About
Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd was incorporated in November 18th, 1977. The Company is actively involved in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). It is engaged in the business of development, manufacture and marketing of pharmaceutical products both formulation and active pharmaceuticals ingredients to regulated and semi-regulated markets.
The company has several molecules in various stages of pre-clinical and clinical development primarily focused in the areas of Oncology, Respiratory and Dermatology. Its branded generics business has a significant presence in markets across emerging economies including India. The company has 14 manufacturing facilities across US, India, Argentina, Czech Republic and Switzerland. The generics business services the requirements of developed markets like the US and Western Europe. The API business sells products in over 80 countries including the US, various countries in the EU, South America and India.
In the year 1979, the company entered dermatology market with the launch of 'Candid Cream'. In the year 1980, they started exporting their products. In the year 1983, the company commissioned their first manufacturing facility at Nasik in Maharashtra. In the year 1984, they established R&D department at Nasik Plant. In the year 1987, they launched Ascoril.
In the year 1989, the company started operations in Afghanistan, Sri Lanka, Kenya and Mauritius. In the year 1982, the company expanded the Nashik plant by acquiring the adjacent plot to include the R&D Department as well as increase in installed production capacity. In the year 1996, the company incorporated a wholly owned subsidiary company namely, Glenmark Exports Pvt Ltd to consolidate their position in international business. In the year 1999, they started marketing their products in Brazil. In the year 2000, they came out with the public issue. They entered in diabetes segment. Also, they acquired three brands from Lyka Labs.
In the year 2001, the company launched API manufacturing business. In the year 2002, they acquired an API manufacturing facility at Ankleshwar, Gujarat from Glaxosmithkline Pharmaceuticals Ltd. In the year 2004, the company entered their first out-licensing deal for discovery R&D with Forest Laboratories for Oglemilast, their CIPD/asthma molecule. They acquired Laboratories Klinger; Brazil together with their ANVISA approved manufacturing facility inorder to expand their operations in the Latin American markets. They commissioned their own manufacturing facility in Goa to service exports to regulated markets, namely USA.
In the year 2005, the company launched commercial sales front-end in the US. They commissioned a new manufacturing facility at Baddi, Himachal Pradesh. They entered collaborative agreement on Oglemilast with Teijin Pharma for the Japan region. Also, they announced collaborative agreement with Napa Pharmaceuticals Inc, for their anti-diarrheas compound Crofelemer. The company acquired Servycal S A, a marketing company in Argentina with strengths in oncology. Also, they acquired Bouwer Bartlett Pty Ltd, a sales and marketing company in South Africa.
In the year 2006, the company signed out-licensing deal in discovery R&D with Merck KGaA, Germany for their diabetes molecule, Melogliptin. Their lead molecule Oglemilast (GRC 3886) entered Phase II clinical trials. In the year 2007, the company acquired Medicamenta, a marketing and manufacturing company in the Czech Republic. Their molecule GRC 6211 for the potential treatment of pain, including osteo-arthritis pain out-licensed to Eli Lily. They received MHRA, UK approval for their semi-solid manufacturing plant at Baddi.
In the year 2008, the company initiated Phase II-b for Oglemilast (GRC 3886) in Asthma. They completed pre-clinical development for initiating Phase I trials for GBR 500, a monoclonal antibody for inflammation. The company's molecule for Rheumatoid Arthritis, GRC 4039, entered Phase I trials. They re-organized their business and incorporated Glenmark Genrics Ltd as a subsidiary company. They received USFDA approval for the state-or-the-art semi-solids manufacturing plant at Baddi. In the year 2009, the company's molecule for neurophatic pain, osteoarthritis, completed the Phase I trials. During the year 2009-10, the company incorporated a subsidiary company, namely Glenmark Generics B.V., Netherlands.
In the year 2010, Crofelemer, a first-in-class anti-diarrhoeal molecule completed phase 3 trials. They received the final approval for Pramipexole Dihydrochloride tablets from the USFDA. Glenmark Generics entered into an exclusive licensing agreement with Par Pharmaceuticals, USA to market Ezetimibe. The company and Sanofi-Aventis signed license agreement to grant Sanofi-Aventis a license for the development and commercialization of novel agents to treat chronic pain. They launched 'Prasugrel', a revolutionary new anti-platelet drug for the management of Acure Coronary Syndrome with PCT (Precutaneous Coronary Intervention) for the first time in India.
During the year 2010-11, the company has incorporated a subsidiary company namely, Glenmark Arzneimittel GmbH, Germany. In October 2010, the company won the Frost and Sullivan Award for 'Indian Innovator Pharmaceutical Company of the year' in October 2010. The company was chosen as the 'Best Company Across Emerging Markets' 2011, and recognized for the 'Best Overall Pipeline' 2011 by SCRIP, the largest selling and most respected pharmaceutical magazine in the world.
In 2012, Forest Laboratories and Glenmark Signed Development Agreement for Worldwide Collaboration on Novel Agents to treat Chronic Inflammatory Conditions. Glenmark Generics announces the settlement of Paragraph IV litigation with Janssen Pharmaceuticals, Inc. Glenmark Generics receives tentative approval for zolmitriptan orally disintegrating tablets. The International Centre for Dispute Resolution ruled in favor of Glenmark on arbitration claim against Napo.
In 2013, Glenmark announces launch of Hydrocortisone Butyrate cream in the US. Glenmark announces a new Discovery and the Initiation of IND enabling studies of a novel monoclonal antibody targeting OX40. The USFDA approves the companies Crofelemer 125 mg delayed-release tablets for the symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART). Glenmark Generics receives ANDA approval for Mupirocin Calcium Cream USP 2%. Atovaquone Prognanil (Malarone) patent revoked & Glenmark launches first UK generic. Glenmark discovers IND enabling studies of a novel monoclonal antibody.
In 2014, Glenmark merge its subsidiaries i.e. Glenmark Generics Ltd. ('GGL') and Glenmark Access Ltd. ('GAL') with GPL. Glenmark enters Oncology with the Discovery and the Initiation of IND enabling studies of an innovative bi-specific antibody. Glenmark Pharmaceuticals inaugurates new Antibody Manufacturing Facility in La Chaux-de-Fonds, Switzerland. US Food & Drug Administration (USFDA) has granted Glenmark its final acceptance for abbreviated new drug approval (ANDA) to the company. Glenmark Pharma receives $5 mn from Sanofi as milestone payment from Sanofi on a collaboration of its VLA2 (alpha2-beta l) integrin monoclonal antibody. Glenmark Generics gets USFDA nod for skin infection cream.
In 2015, Glenmark Pharmaceuticals Ltd announces approval and launch of Ashlyna TM Extended - Cycle Oral Contraceptive Tablets in the US. Glenmark Pharmaceuticals Ltd announces approval and launch of Trandolapril & Verapamil Hydrochloride (HCI). Glenmark Pharma gets US FDA nod for Salmecort MDI Inhaler in Russia. The Cabinet Committee on Economic Affairs (CCEA) headed by PM approves the foreign investment proposals of two pharma majors Glenmark Pharmaceuticals and Aurobindo Pharma worth Rs 4,187 crore. Glenmark Pharmaceuticals Ltd. has certified approving the Scheme of Arrangement of Glenmark Generics Ltd. and Glenmark Access Ltd. with Glenmark Pharmaceuticals Ltd. Glenmark announces Strategic Development & Licensing Agreement with Celon, Poland for generic Seretide Accuhaler in Europe. Glenmark Pharmaceuticals receives tentative ANDA approval for Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg. Glenmark Pharmaceuticals receives ANDA approval for Clotrimazole and Betamethasone Dipropionate Cream USP, 1%: 0.05%. Glenmark Pharmaceuticals has entered into a settlement agreement with Forest Laboratories, LLC, Forest Laboratories Holdings, Ltd., and Royalty Pharma. During the year, the company received approval for generic Seretide in Russia.
On 19 September 2016, Glenmark Pharmaceuticals, Inc., USA announced that it has entered into a strategic Development, License and Commercialization Agreement with Particle Sciences, Inc. to develop and market a generic version of Celgene's ABRAXANE product - paclitaxel protein (albumin)-bound particles for injectable suspension. As per the terms of the agreement, Glenmark has obtained Global Exclusive Marketing and Distribution rights of the product upon commercialization. Particle Sciences will develop this product exclusively for Glenmark, and shall receive certain milestone payments during various stages of the product's development from Glenmark, including royalties on sales.
On 12 December 2016, Glenmark Pharmaceuticals Inc., USA announced the availability of ezetimibe, the first and only generic version of ZETIA (Merck) in the United States for the treatment of high cholesterol. The availability of ezetimibe is the result of a licensing partnership with Par Pharmaceutical, an Endo International plc operating company, with whom Glenmark will share profits. Glenmark and its partner, Endo will be entitled to 180 days of generic drug exclusivity for ezetimibe as provided for under Section 505 (j) (5) (B) (iv) of the FD&C Act.
On 19 December 2016, Glenmark Pharmaceuticals announced its strategic blueprint to transition into an innovation-led global pharmaceutical organization over the next decade. The Blueprint conveys the company's greater business alignment expanding generics to prioritizing research and development efforts in three key therapeutic areas: oncology, respiratory and dermatology. The innovative oncology pipeline, with candidates targeting multiple tumors, is the top priority with the greater promise to deliver novel, first-in-class molecules and help Glenmark evolve into a fully commercialized, innovation-led pharmaceutical company. The strategic blueprint also outlines aggressive plans to increase Glenmark's presence worldwide by strengthening focus on complex generics including injectables and expanding its manufacturing footprint.
On 2 March 2017, Glenmark Pharmaceuticals announced that its US subsidiary Glenmark Pharmaceuticals Inc., USA, and Evestra, Inc. have completed a strategic development, license and commercialization agreement to develop and market a generic version of Merck's & Co.'s NuvaRing product - etonogestrel/ethinyl estradiol vaginal ring - designed to allow women access to a more affordable birth control option. Development on the vaginal ring product is currently under way and the two companies expect to file an Abbreviated New Drug Application (ANDA) in fiscal 2019. Evestra will develop this product exclusively for Glenmark for the US market, and will receive certain milestone payments during various stages of the product's development, including royalties on net sales. Glenmark has secured exclusive marketing and distribution rights for the product, including an option to commercialize two additional Evestra vaginal ring products, for the US market.
On 30 March 2017, Glenmark Pharmaceuticals announced positive results for GSP 301, an investigational fixed-dose combination of mometasone furoate (25 mcg) and olopatadine hydrochloride (665 mcg) administered twice daily as a nasal spray being studied for the treatment of seasonal allergic rhinitis. These results are from a recently completed Phase 3 trial assessing the efficacy and safety of GSP 301 combination therapy versus mometasone, olopatadine or placebo.
On 14 December 2017, Glenmark Pharmaceuticals announced that it met its primary clinical endpoint in a Phase 3 study evaluating the safety of Ryaltris, an investigational fixed-dose combination nasal spray, in perennial allergic rhinitis (PAR). Ryaltris has conditionally accepted as the brand name for GSP 301 Nasal Spray by the US Food & Drug Administration (FDA). Glenmark plans to submit the company's first new drug application (NDA) to the FDA for Ryaltris for the treatment of patients with seasonal allergic rhinitis (SAR) in the first quarter of CY 2018.
On 22 February 2018, Glenmark Pharmaceuticals announced that it has entered into an exclusive agreement with South Korea's Sam Chun Dang Pharm. Co. Ltd. (SCD), to develop, manufacture and market a portfolio of ophthalmic products in the US and Canada. Under this agreement, these products will be developed and manufactured by SCD in South Korea. Glenmark will seek all market authorizations and commercialize the products in North America.
On 4 April 2018, Glenmark Pharmaceuticals and Helsinn Group (Helsinn), a Swiss pharmaceutical group focused on building quality cancer care products, announced that they have entered into an exclusive licensing agreement to introduce AKYNZEO in India and Nepal. AKYNZEO, an oral fixed combination of netupitant 300mg and palonosetron 0.5mg in capsule form, is used for prevention of Chemotherapy-induced Nausea and Vomiting (CINV). The licensing agreement with Glenmark for AKYNZEO represents Helsinn's first such agreement in India. Glenmark will have exclusive marketing rights for AKYNZEO in India and Nepal.
On 22 May 2018, Glenmark Pharmaceuticals announced that the company has submitted a New Drug Application (NDA) to the US Food & Drug Administration (FDA) for its leading respiratory pipeline candidate Ryaltris, an investigational fixed-dose combination nasal spray of an antihistamine and a steroid, as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older. Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg), formerly GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name.
On 19 June 2018, Glenmark Pharmaceuticals announced that the US Food & Drug Administration provided its first supplemental Abbreviated New Drug Applications (ANDA) approval for the company's manufacturing facility in Monroe, North Carolina. The approval covers: Atovaquone and Proguanil Hydrochloride Tablets, 250 MG/100 MG and 62.5 MG/25 MG, a generic version of GlaxoSmithKline's Malarone (atovaquone and proguanil hydrochloride) Tablets. The Monroe, North Carolina facility is Glenmark's first manufacturing site in the US, designed to manufacture a variety of fixed dose pharmaceutical formulations. Glenmark has invested more than $100 million into the facility with plans for further expansion in the coming years. At peak capacity, the site is anticipated to produce 300-400 million tablets and capsules, 20-25 million vials and pre-filled syringes and 25-30 million ampoules for inhaled formulations.
During the F.Y. 2017-18 Glenmark Pharmaceuticals Singapore Pte. Ltd. was formed as the wholly owned subsidiary of the company
In FY18, Glenmark was granted approval of 21 Abbreviated New Drug Applications (ANDA), comprising 18 final approvals and three tentative approvals. Notable approvals include Aprepitant Capsules USP, Atomoxetine Capsules USP, Nitroglycerin Sublingual Tablets and Propafenone Hydrochloride Extended-Release Capsules USP. The Company filed a total of 16 ANDA applications with the US FDA throughout the fiscal year.
During the year 2018, Glenmark launched Dermikelp, VWash Plus, Tacroz and Tacroz F in Zambia; Tacroz and Telma H in Tanzania; Ascoril D, Teneligliptin and its combination with Metformin in Mauritius, Momate F in Uganda and Sertaconazole (Onabet) in Sudan.
During the year 2018, Glenmark launched Tacroz, Dosetil and Momate NS in Philippines; Momate NS, Dermikelp and VWash in Malaysia and Konzert in Cambodia in the Asia region.
As on March 31 2018, the Company has filed over 370 Global DMFs in various markets, including 103 USDMFs, 28 CEPs, 40 EU- DMFs, 22 Canadian DMFs, 12 Japan DMFs, 13 Australian DMFs and other DMFs in various Rest-of-the-World (ROW) countries.
During the year 2018, NebZmart, NebZsol and Vocety were launched in Brazil. In Colombia, the Company strengthened its dermatology portfolio and introduced Glenpalene, Glenpalene C, Dermotil S, Glencort, Butemax and Clotridid. Momate AZ nasal spray was launched in the Caribbean region and Glenmark is the first generic alternative in the market offering this unique combination.
In FY18, Momate Rhino Advance, a unique combination of mometasone + azelastine nasal spray on the local market, was launched in Uzbekistan and is indicated for the treatment of patients with seasonal allergic rhinitis. Momat Rino 60 and 120 doses nasal sprays were also launched in Uzbekistan. During the year, Glenmark launched Glenspray (mometasone) 50 mcg/120 doses and Glenspray (mometasone) 50 mcg/60 doses in Ukraine.
During the year 2018, Glenmark also successfully concluded the US FDA audit of the API plant at Mohol and is awaiting the EIR from the agency.
During the year 2018-19, the Company acquired 100% stake in Zorg Laboratories Private Limited (Zorg) for an aggregate consideration of 5 lacs before adjustments and subject to legal and financial due diligence. Subsequently, name of Zorg was changed to Glenmark Life Sciences Limited (GLS). The shareholders of the Company approved the transfer of its Active Pharmaceuticals Business (API) to GLS by passing a resolution through postal ballot.
During the FY2019, the Company had entered into a collaboration with leading, home-grown private equity firm True North Enterprise Private Limited (True North') and transferred its Orthopaedic and Pain management business valued at Rs 635 crore to Integrace Private Limited, a subsidiary of True North. Integrace will market the product portfolio in India and Nepal.
As on 31 March 2019,the company has 42 subsidiary companies under its roof.
The Company filed a total of 13 ANDAs with the USFDA during the financial year. In FY 2018-19, Glenmark was granted approval for 25 Abbreviated New Drug Applications (ANDA), comprising of 20 final approvals and 5 tentative approvals.
During the year, the company bagged CII Safety Health and Environmental Excellence and Innovation Award 2018 for the Indore facility.
During the FY2020,the Company had entered into Business Transfer Agreement with Integrace Private Limited for transfer Company's Gynaecology business, valued at Rs 115 crore.
During the year, the Company entered into definitive agreement with Hindustan Unilever Limited for divestment of VWash franchise comprising VWash Plus Intimate Hygiene Wash, VWash WOW, VWash Plus Bikini Line, VWash Plus wipes and other such assets globally including the associated trademarks, brand names and certain business contracts.
It launched a globally researched innovator molecule, Remogliflozin in FY 2019.
As on 31 March 2020, the company has 44 subsidiary companies under roof. It introduced a fixed-dose combination of Remogliflozin Etabonate and Vildagliptin in 2020. It also launched a fixed-dose combination of Remogliflozin+Metformin under the brand names Remo-M and Remo-Zen M.
Glenmark Life Sciences Limited, a wholly owned subsidiary of the Company on 16th April 2021 has filed a draft red herring prospectus with the Securities and Exchange Board of India for an initial public offer, comprising of a fresh issue of up to Rs. 11,600 million and an offer for sale of up to 7,305,245 equity shares of Rs. 2 each of Glenmark Life Sciences Limited, by Glenmark Pharmaceuticals Limited. The !PO will be subject to market conditions, receipt of applicable approvals and other considerations.
In the fiscal year 2020-21, Glenmark was granted approval of 14 ANDAs comprised of 10 final approvals and 4 tentative approvals. Additionally, it was granted approval on a Prior Approval Supplement (PAS) for the 0.25 mg strength for Fingnolimod Capsules. Notable approvals include: Sirolimus Tablets, Tacrolimus Capsules USP, Topiramate Extended-Release Capsules USP, Chlorpromazine Hydrochloride Tablets USP and Diltiazem Hydrochloride Extended-Release Capsules USP. The Company filed a total of 7 ANDAs with the USFDA in FY21 and plan to file 18-20 ANDAs in FY22 including 5-6 filings which got delayed in FY21 due to the pandemic. During 2021, its subsidiary, Ichnos Sciences signed a licensing agreement with Almirall SA for the IL-1RAP antagonist ISB 880 for an upfront payment of EUR 20.8 Million. It received approval for 14 ANDAs that comprised 10 final approvals and 4 tentative approvals. It launched 10 new products in FY 2020-21. On 30th April, 2021, the Company made a strategic investment of Rs. 400 million in ABCD Technologies LLP .
During the year 2022, Company received US FDA's NDA approval for novel Ryaltris-AZ as a novel fixed dose with a steroid of Mometasone Furoate and Azelastine for the treatment of allergic rhinitis in adults and paediatric patients 12 years of age and older. It launched Tiotropium Bromide Dry Powder Inhaler (DPI) in UK. It launched Tavulus in Spain and Tiotropium in Germany. It also launched Beclometasone to provide asthma patients access to a high-quality, cost-effective inhaler. It launched Glendes in Malaysia for treatment of minor cases of allergy. In Brazil, it launched Salbutamol to relieve symptoms of asthma and chronic obstructive pulmonary disease (COPD) such as coughing, wheezing and feeling breathless. It launched Canditral- SB in India to treat fungal infections of the mouth, throat, toenails, fingernails or lungs. To treat the symptoms of LennoxGastaut Syndrome (seizures), it launched Rufinamide tablets in the USA. It collaborated with Canadian biotech firm SaNOtize Research & Development Corp. to manufacture, market and distribute its breakthrough Nitric Oxide Nasal Spray (NONS) for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam. It launched NONS under the brand name FabiSpray in February 2022, after receiving manufacturing and marketing approval from the Drugs Controller General of India (DCGI) as part of the accelerated approval process. Ichnos Sciences Inc., a subsidiary of Glenmark completed a EUR ~21 Million exclusive licensing agreement for the IL-1RAP antagonist ISB 880. Remogliflozin, Vildagliptin, Metformin, a Fixed Dose Combination (FDC) was launched during the year to enhance patient access to SGLT2 and DPP4 inhibitors for effective treatment of diabetes. FabiSpray was also launched in Singapore and Hong Kong under the brand name VirX. It introduced India's first Probiotic based product across its dermatology portfolio, such as Elovera Pro Cream and Elovera Pro Lotion. It launched 10 new products in the US taking total marketing portfolio in US 174 generic products authorized for distribution in the U.S. market. It entered into an agreement with AstraZeneca to commercialize its product, Pulmicort Respules in Colombia. Besides this, it entered into exclusive licensing agreement with Lotus International Pte. Ltd. for commercializing Ryaltris in Singapore, Hong Kong and Vietnam. Three new pharmaceutical modules became fully operational at its Ankleshwar facility.
During the year 2022-23, in the Respiratory segment, Glenmark became the first company in India to market Indamet - an innovative fixed drug combination of Indaceterol, a long-acting beta-agonist and mometasone, an inhaled corticosteroid, for the treatment of uncontrolled asthma. In the Diabetes segment, it launched sitagliptin under the brand name SITAZIT and its fixed dose combinations with metformin and dapagliflozin respectively; teneligliptin + pioglitazone Fixed-Dose Combination drug for Type 2 Diabetes under the brand name Zita Plus Pio; lobeglitazone 0.5mg, under the brand name LOBG; Fixed-Dose Combination (FDC) of Teneligliptin (20 mg) + Pioglitazone (15 mg) + Metformin (500mg/1000mg) SR under the brand name Zita-PioMet; Lobeglitazone + Metformin under the brand name LOBG-M. In the Cardio-Vascular segment, it launched Sacubitril + Valsartan under the brand name, Sacu V for the treatment of heart failure. New products such as La Shield Pollution Protect, La Shield Probiotic Moisturizer and Scalpe Pro Shampoo contributed to business growth in FY23.
Thereafter, in FY23, Glenmark launched 8 new products during the fiscal year 2022-23, consisting of a mix of immediate-release oral solids and an injectable. Notable launches include Ezetimibe Tablets USP; Abiraterone Acetate Tablets USP, 500 mg; Fingolimod Capsules, 0.5 mg; Sodium Phenylbutyrate Tablets USP, 500 mg; Nicardipine Hydrochloride Capsules; Bumetanide Injection, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials; and 2.5 mg/10 mL (0.25 mg/mL) Multi-Dose Vials, and Teriflunomide Tablets. It launched first generics, Teriflunomide (Aubagio) Tablets. It got into a distribution agreement with Cediprof for USFDA approved Mixed Amphetamines Immediate-Release Tablets.
As of March 31, 2023, Glenmark's marketing portfolio included 183 generic products authorized for distribution in the U.S. market. 4 new products were introduced in the market, including Fenismart(dimetindene) gel and Phelisans (phenasone + lidocaine) ear drops. It launched RYALTRIS in the Malaysian market in 4Q of FY23.
Glenmark Pharmaceuticals Ltd
Chairman Speech
Dear Shareholder,
We have just seen a year of extraordinary challenges, a year that has
changed our lives in different ways. The COVID-19 pandemic has created immense disruption
in the global economy and the healthcare sector.
The unpredictability remains, and we expect that the coming year will
continue to test our resilience and determination to navigate volatility.
As an organization, it was apparent to us right at the beginning that
COVID-19 was a one-of-a-kind situation facing humanity and our industry, and its effects
would be far-reaching. We also realized that to succeed in such a business environment,
organizations needed to adopt a different mindset. Undoubtedly, the tenets of doing
business in a post-COVID world are resilience, adaptability, and flexibility. Only with
these capabilities can an organization align itself to the changing reality, and continue
to create value for its customers and other stakeholders.
Our response to COVID-19 was unparalleled, and it put us on par with
other global pharmaceutical companies that worked against the clock to find treatment
options for COVID-19.
Our performance demonstrated our operational robustness and ability to
cater to diverse patient needs in challenging situations. Our competitive advantage came
from our timely action, quick adaptation, and purposeful innovation - with a firm focus on
business continuity. Every team and business function across Glenmark embraced agility in
its way of working from the onset of the pandemic.
FabiFlu: Glenmark's timely response to the pandemic
Our oral antiviral, FabiFlu (favipiravir), is a testament to the deep
capabilities that define brand Glenmark. In March 2020, the World Health Organization
declared the COVID-19 a global pandemic.
In less than three months, Glenmark became the first pharmaceutical
company in India to receive emergency use authorization for FabiFlu. I am proud to say
that we ploughed through all challenges to ensure that our therapy reached more than 5
million patients in India, making the impact real, tangible, and timely. By April 2021,
FabiFlu had become the highest selling drug in the Indian pharma market amongst all
therapies.
Recalibration for a new reality
We demonstrated operational resilience and agility in our successful
clearing of virtual audits, and in our introduction of digital tools to communicate with
doctors and sales staff.
Our collaborative mindset saw our Operations and Manufacturing teams
working seamlessly round the clock to produce an uninterrupted supply of medicines for
patients around the world. Thus honoring our commitment to patients, partners, and the
community.
Our frontline and corporate functions further re- examined and
recalibrated their business models, and worked in unison to achieve new milestones and set
new benchmarks of excellence.
Leading through innovation
Innovation is how we generate value. Our investments in R&D go
beyond launching generics, and fuel development of innovative products that raise the
standard of care for diseases with significant unmet needs.
We launched a number of products in FY21. In addition to FabiFlu, the
other significant launch was Ryaltris™ (olopatadine hydrochloride and mometasone
furoate monohydrate), an anti-allergy nasal spray that is being marketed globally.
Ryaltris™ sales continue to progress well in Australia, South Africa, Ukraine and
Uzbekistan. We have initiated launch in Russia and received marketing approval for launch
in the Philippines.
We are entering into partnership agreements for the commercialization
of Ryaltris™ in other countries and plan to launch it on our own in some markets.
Glenmark's novel, patent-protected, and globally- researched sodium
glucose co-transporter-2 (SGLT2) inhibitor, Remogliflozin Etabonate(Remogliflozin), for
the treatment of type 2 diabetes, continues to do well in India.
Furthermore, Glenmark has received a positive response to the launch of
the Remogliflozin + Vildagliptin fixed dose combination, underthe brand names Remo V and
Remozen V, for adults with type 2 diabetes in India. The brands have gained a market share
of 37.9% in the SGLT/DPP4 market, according to IQVIA Jan-March 2021 data.
Our specialty/innovative pipeline
GRC 17536 (TRPA1 antagonist) is a specialty asset being developed as an
orally administered treatment for patients with painful diabetic peripheral neuropathy.
We announced the successful Phase 1 results of GBR 310 that suggest
similarity in pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles
between GBR 310 and the reference product, omalizumab, marketed in the US under the brand
name Xolair. We are in discussions with potential partners and plan to finalize a deal
before initiating Phase 3 studies.
GRC 39815 (RORyt antagonist) is the company's respiratory pipeline
asset, that is being developed as an inhaled therapy for the treatment of mild to moderate
chronic obstructive pulmonary disease (COPD). It is currently under Phase 1 clinical
development with a single ascending dose study in the US. The Phase 1 study is expected to
be completed in the next few quarters.
In oncology, our pipeline molecule - GRC 54276 (HPK1 inhibitor) - is
being developed as an orally administered, immuno-oncology-adjuvanttreatment for patients
with solid tumors.
In the dermatology segment, we are evaluating GRC 4039 (PDE4 inhibitor)
as a topically administered treatment for patients with mild to moderate atopic
dermatitis.
An impressive pipeline from Ichnos
Our biologics pipeline in Ichnos is gaining traction. In FY21, we made
a strategic decision to refine the Ichnos pipeline by sharpening our focus on oncology
biologics based on BEAT, our proprietary, bi-/trispecific engineering platform, and
out-licensing our immunology assets.
The technology platform is enabling us to develop novel immune cell
engagers and modulators in oncology. It will help us realize our mission to provide
breakthrough therapies that will extend and improve lives, and thereby write a new chapter
in healthcare.
Ichnos' current, multi-specific oncology pipeline consists of five
programs, including a clinical-stage, first-in-class T-cell engager, ISB 1342,
thattargetsCD38 and CD3; and a preclinical-stage, first-in-class CD38 x CD47 immune cell
engager, ISB 1442, which leverages multiple mechanisms of cellular cytotoxicity.
Additionally, Ichnos is working to out-license two antibodies with
potential across a range of autoimmune diseases. ISB 830 (telazorlimab), an 0X40
antagonist monoclonal antibody (mAb), is in Phase 2b trials for the treatment of atopic
dermatitis. ISB 880 is a preclinical stage, high-affinity IL-1RAP antagonist mAb that is
being targeted for IND submission bythe end of fiscal year 2021-2022.
A positive performance
Despite multiple challenges, our business has remained stable and is
growing. Forthe year under review (2020- 21), Glenmark's consolidated revenue recorded an
increase of 2.8% to reach INR1,09,439 Mn, as against INR 1,06,410 Mn overthe previous
corresponding period. Net profit stood at INR 9,701 Mn in FY21, as against INR 7,760 Mn in
the previous fiscal - a growth of 25%.
Glenmark stayed its course as one of the fastest growing companies in
India, with a growth of 14% versus the average growth rate of 6% in the Indian
pharmaceutical market. Our prescription (Rx) business in India continued to drive market
share in respiratory, dermatology, oncology, and cardio-metabolics. Today, Glenmark is
ranked 2nd in dermatology, 3rd in respiratory medicine, 6th
in cardiology, and is amongst the top 15 companies in the diabetes and oncology space in
the country.
The Glenmark Consumer Care (GCC) business maintained its lead with top
brands Candid, LaShield, and Scalpe. It is a matter of pride for us that in FY21,
Candid powder became the first GCC brand with sales of over INR 1 Bn (INR 100Cr+).
Broadening our global presence
In the fiscal year 2020-21, Glenmark received approval for 14 ANDAs
that comprised 10 final approvals and four tentative approvals. Today, Glenmark is ranked
15th in the US amongst generic companies (in terms of volume) and 17th
in terms of total prescriptions. Our products fill about 83 Mn prescriptions each year in
the US, and this number is expected to continue increasing annually.
Glenmark has built a strong presence across key markets in Western and
Central Eastern Europe. Our present geographies include the UK, Germany, the Netherlands,
Spain, the Czech Republic, the Nordic countries, Slovakia, Poland, and Romania. For this
financial year, the European region signed 21 major contractsforin-licensing products.
Restof theworld markets continue to be an emerging growth area. We have now expanded in
regions such as Australia and Thailand.
Reorganizing to resurge
A strategic restructuring of the organization enabled us to build a
leading, focused, and integrated pharmaceutical company powered by advanced therapy
platforms. We spun off our API business and biologics divisions into separate
subsidiaries, to unlock their value and propel them into new growth trajectories.
Following the restructuring, the company's flagship brand, Glenmark
Pharmaceuticals Ltd., continues to focus on generics, branded, and specialty/innovative
products. The API subsidiary (Glenmark Life Sciences) is expected to show robust growth,
with the world looking at India to de-risk its supply chain for its API needs. Ichnos
Sciences Inc. is Glenmark's US-based innovation biologics business that is working on
expediting the development of oncology and autoimmune medicines. All three entities
operate independently with separate management teams and Boards of Directors.
Glenmark Life Sciences is now separately listed on the Indian Stock
Exchanges (BSE and NSE) under the ticker 'GLS'.
Future outlook
Glenmark will continue to forge ahead as an integrated, innovation-led,
global pharmaceutical company. It extends across the pharmaceutical value chain from API
to finished formulations, harnesses technologies from complex chemistry to biologics, and
makes products from affordable generics to value-added specialties, and soon, cutting-edge
innovation.
We expect to see robust growth across major geographies and emerging
markets. Our focus for FY22 comprises deepening our presence in existing geographies and
expanding our portfolio in new markets. We are also working on building a strong, global
compliance framework, and investing in further automation across our manufacturing plants,
to drive qualityand efficiency.
Glenmark Pharmaceuticals:
The long-term goal of Glenmark Pharmaceuticals is to move up the value
chain into complex generics, specialty products, and innovative products. We continue our
present focus on the key therapy areas of respiratory, dermatology, and oncology, and aim
to develop a strong regional presence in select therapeutic areas.
In India, we expect to drive our market leading growth by centering our
efforts on our key therapy areas, expanding our reach by utilizing new ways of digital
communications, and growing our portfolio of OTC products.
Glenmark signed an exclusive partnership with Canadian biotech SaNOtize
Research & Development Corp. to manufacture, market and distribute its novel
preventive breakthrough Nitric Oxide Nasal Spray (NONS) for COVID-19 treatment in India
and other Asian markets. Glenmark's FabiSpray, is an effective antiviral treatment to
prevent COVID-19 transmission, shorten its course, and reduce symptom severity. We expect
to complete Phase III clinical trials for NONS, followed by its commercial launch in
India, by the fourth quarter of 2021.
In North America, Glenmark has over 171 products authorized for
distribution in the US and another 41 products pending authorization. We are working to
file 18-20 ANDAs in FY22, including 5-6 filings that got delayed in FY21 because of the
pandemic. The Monroe facility will play a critical role in this endeavor.
Glenmark Pharmaceuticals Ltd
Company History
Glenmark Pharmaceuticals Ltd was incorporated in November 18th, 1977. The Company is actively involved in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). It is engaged in the business of development, manufacture and marketing of pharmaceutical products both formulation and active pharmaceuticals ingredients to regulated and semi-regulated markets.
The company has several molecules in various stages of pre-clinical and clinical development primarily focused in the areas of Oncology, Respiratory and Dermatology. Its branded generics business has a significant presence in markets across emerging economies including India. The company has 14 manufacturing facilities across US, India, Argentina, Czech Republic and Switzerland. The generics business services the requirements of developed markets like the US and Western Europe. The API business sells products in over 80 countries including the US, various countries in the EU, South America and India.
In the year 1979, the company entered dermatology market with the launch of 'Candid Cream'. In the year 1980, they started exporting their products. In the year 1983, the company commissioned their first manufacturing facility at Nasik in Maharashtra. In the year 1984, they established R&D department at Nasik Plant. In the year 1987, they launched Ascoril.
In the year 1989, the company started operations in Afghanistan, Sri Lanka, Kenya and Mauritius. In the year 1982, the company expanded the Nashik plant by acquiring the adjacent plot to include the R&D Department as well as increase in installed production capacity. In the year 1996, the company incorporated a wholly owned subsidiary company namely, Glenmark Exports Pvt Ltd to consolidate their position in international business. In the year 1999, they started marketing their products in Brazil. In the year 2000, they came out with the public issue. They entered in diabetes segment. Also, they acquired three brands from Lyka Labs.
In the year 2001, the company launched API manufacturing business. In the year 2002, they acquired an API manufacturing facility at Ankleshwar, Gujarat from Glaxosmithkline Pharmaceuticals Ltd. In the year 2004, the company entered their first out-licensing deal for discovery R&D with Forest Laboratories for Oglemilast, their CIPD/asthma molecule. They acquired Laboratories Klinger; Brazil together with their ANVISA approved manufacturing facility inorder to expand their operations in the Latin American markets. They commissioned their own manufacturing facility in Goa to service exports to regulated markets, namely USA.
In the year 2005, the company launched commercial sales front-end in the US. They commissioned a new manufacturing facility at Baddi, Himachal Pradesh. They entered collaborative agreement on Oglemilast with Teijin Pharma for the Japan region. Also, they announced collaborative agreement with Napa Pharmaceuticals Inc, for their anti-diarrheas compound Crofelemer. The company acquired Servycal S A, a marketing company in Argentina with strengths in oncology. Also, they acquired Bouwer Bartlett Pty Ltd, a sales and marketing company in South Africa.
In the year 2006, the company signed out-licensing deal in discovery R&D with Merck KGaA, Germany for their diabetes molecule, Melogliptin. Their lead molecule Oglemilast (GRC 3886) entered Phase II clinical trials. In the year 2007, the company acquired Medicamenta, a marketing and manufacturing company in the Czech Republic. Their molecule GRC 6211 for the potential treatment of pain, including osteo-arthritis pain out-licensed to Eli Lily. They received MHRA, UK approval for their semi-solid manufacturing plant at Baddi.
In the year 2008, the company initiated Phase II-b for Oglemilast (GRC 3886) in Asthma. They completed pre-clinical development for initiating Phase I trials for GBR 500, a monoclonal antibody for inflammation. The company's molecule for Rheumatoid Arthritis, GRC 4039, entered Phase I trials. They re-organized their business and incorporated Glenmark Genrics Ltd as a subsidiary company. They received USFDA approval for the state-or-the-art semi-solids manufacturing plant at Baddi. In the year 2009, the company's molecule for neurophatic pain, osteoarthritis, completed the Phase I trials. During the year 2009-10, the company incorporated a subsidiary company, namely Glenmark Generics B.V., Netherlands.
In the year 2010, Crofelemer, a first-in-class anti-diarrhoeal molecule completed phase 3 trials. They received the final approval for Pramipexole Dihydrochloride tablets from the USFDA. Glenmark Generics entered into an exclusive licensing agreement with Par Pharmaceuticals, USA to market Ezetimibe. The company and Sanofi-Aventis signed license agreement to grant Sanofi-Aventis a license for the development and commercialization of novel agents to treat chronic pain. They launched 'Prasugrel', a revolutionary new anti-platelet drug for the management of Acure Coronary Syndrome with PCT (Precutaneous Coronary Intervention) for the first time in India.
During the year 2010-11, the company has incorporated a subsidiary company namely, Glenmark Arzneimittel GmbH, Germany. In October 2010, the company won the Frost and Sullivan Award for 'Indian Innovator Pharmaceutical Company of the year' in October 2010. The company was chosen as the 'Best Company Across Emerging Markets' 2011, and recognized for the 'Best Overall Pipeline' 2011 by SCRIP, the largest selling and most respected pharmaceutical magazine in the world.
In 2012, Forest Laboratories and Glenmark Signed Development Agreement for Worldwide Collaboration on Novel Agents to treat Chronic Inflammatory Conditions. Glenmark Generics announces the settlement of Paragraph IV litigation with Janssen Pharmaceuticals, Inc. Glenmark Generics receives tentative approval for zolmitriptan orally disintegrating tablets. The International Centre for Dispute Resolution ruled in favor of Glenmark on arbitration claim against Napo.
In 2013, Glenmark announces launch of Hydrocortisone Butyrate cream in the US. Glenmark announces a new Discovery and the Initiation of IND enabling studies of a novel monoclonal antibody targeting OX40. The USFDA approves the companies Crofelemer 125 mg delayed-release tablets for the symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy (ART). Glenmark Generics receives ANDA approval for Mupirocin Calcium Cream USP 2%. Atovaquone Prognanil (Malarone) patent revoked & Glenmark launches first UK generic. Glenmark discovers IND enabling studies of a novel monoclonal antibody.
In 2014, Glenmark merge its subsidiaries i.e. Glenmark Generics Ltd. ('GGL') and Glenmark Access Ltd. ('GAL') with GPL. Glenmark enters Oncology with the Discovery and the Initiation of IND enabling studies of an innovative bi-specific antibody. Glenmark Pharmaceuticals inaugurates new Antibody Manufacturing Facility in La Chaux-de-Fonds, Switzerland. US Food & Drug Administration (USFDA) has granted Glenmark its final acceptance for abbreviated new drug approval (ANDA) to the company. Glenmark Pharma receives $5 mn from Sanofi as milestone payment from Sanofi on a collaboration of its VLA2 (alpha2-beta l) integrin monoclonal antibody. Glenmark Generics gets USFDA nod for skin infection cream.
In 2015, Glenmark Pharmaceuticals Ltd announces approval and launch of Ashlyna TM Extended - Cycle Oral Contraceptive Tablets in the US. Glenmark Pharmaceuticals Ltd announces approval and launch of Trandolapril & Verapamil Hydrochloride (HCI). Glenmark Pharma gets US FDA nod for Salmecort MDI Inhaler in Russia. The Cabinet Committee on Economic Affairs (CCEA) headed by PM approves the foreign investment proposals of two pharma majors Glenmark Pharmaceuticals and Aurobindo Pharma worth Rs 4,187 crore. Glenmark Pharmaceuticals Ltd. has certified approving the Scheme of Arrangement of Glenmark Generics Ltd. and Glenmark Access Ltd. with Glenmark Pharmaceuticals Ltd. Glenmark announces Strategic Development & Licensing Agreement with Celon, Poland for generic Seretide Accuhaler in Europe. Glenmark Pharmaceuticals receives tentative ANDA approval for Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg. Glenmark Pharmaceuticals receives ANDA approval for Clotrimazole and Betamethasone Dipropionate Cream USP, 1%: 0.05%. Glenmark Pharmaceuticals has entered into a settlement agreement with Forest Laboratories, LLC, Forest Laboratories Holdings, Ltd., and Royalty Pharma. During the year, the company received approval for generic Seretide in Russia.
On 19 September 2016, Glenmark Pharmaceuticals, Inc., USA announced that it has entered into a strategic Development, License and Commercialization Agreement with Particle Sciences, Inc. to develop and market a generic version of Celgene's ABRAXANE product - paclitaxel protein (albumin)-bound particles for injectable suspension. As per the terms of the agreement, Glenmark has obtained Global Exclusive Marketing and Distribution rights of the product upon commercialization. Particle Sciences will develop this product exclusively for Glenmark, and shall receive certain milestone payments during various stages of the product's development from Glenmark, including royalties on sales.
On 12 December 2016, Glenmark Pharmaceuticals Inc., USA announced the availability of ezetimibe, the first and only generic version of ZETIA (Merck) in the United States for the treatment of high cholesterol. The availability of ezetimibe is the result of a licensing partnership with Par Pharmaceutical, an Endo International plc operating company, with whom Glenmark will share profits. Glenmark and its partner, Endo will be entitled to 180 days of generic drug exclusivity for ezetimibe as provided for under Section 505 (j) (5) (B) (iv) of the FD&C Act.
On 19 December 2016, Glenmark Pharmaceuticals announced its strategic blueprint to transition into an innovation-led global pharmaceutical organization over the next decade. The Blueprint conveys the company's greater business alignment expanding generics to prioritizing research and development efforts in three key therapeutic areas: oncology, respiratory and dermatology. The innovative oncology pipeline, with candidates targeting multiple tumors, is the top priority with the greater promise to deliver novel, first-in-class molecules and help Glenmark evolve into a fully commercialized, innovation-led pharmaceutical company. The strategic blueprint also outlines aggressive plans to increase Glenmark's presence worldwide by strengthening focus on complex generics including injectables and expanding its manufacturing footprint.
On 2 March 2017, Glenmark Pharmaceuticals announced that its US subsidiary Glenmark Pharmaceuticals Inc., USA, and Evestra, Inc. have completed a strategic development, license and commercialization agreement to develop and market a generic version of Merck's & Co.'s NuvaRing product - etonogestrel/ethinyl estradiol vaginal ring - designed to allow women access to a more affordable birth control option. Development on the vaginal ring product is currently under way and the two companies expect to file an Abbreviated New Drug Application (ANDA) in fiscal 2019. Evestra will develop this product exclusively for Glenmark for the US market, and will receive certain milestone payments during various stages of the product's development, including royalties on net sales. Glenmark has secured exclusive marketing and distribution rights for the product, including an option to commercialize two additional Evestra vaginal ring products, for the US market.
On 30 March 2017, Glenmark Pharmaceuticals announced positive results for GSP 301, an investigational fixed-dose combination of mometasone furoate (25 mcg) and olopatadine hydrochloride (665 mcg) administered twice daily as a nasal spray being studied for the treatment of seasonal allergic rhinitis. These results are from a recently completed Phase 3 trial assessing the efficacy and safety of GSP 301 combination therapy versus mometasone, olopatadine or placebo.
On 14 December 2017, Glenmark Pharmaceuticals announced that it met its primary clinical endpoint in a Phase 3 study evaluating the safety of Ryaltris, an investigational fixed-dose combination nasal spray, in perennial allergic rhinitis (PAR). Ryaltris has conditionally accepted as the brand name for GSP 301 Nasal Spray by the US Food & Drug Administration (FDA). Glenmark plans to submit the company's first new drug application (NDA) to the FDA for Ryaltris for the treatment of patients with seasonal allergic rhinitis (SAR) in the first quarter of CY 2018.
On 22 February 2018, Glenmark Pharmaceuticals announced that it has entered into an exclusive agreement with South Korea's Sam Chun Dang Pharm. Co. Ltd. (SCD), to develop, manufacture and market a portfolio of ophthalmic products in the US and Canada. Under this agreement, these products will be developed and manufactured by SCD in South Korea. Glenmark will seek all market authorizations and commercialize the products in North America.
On 4 April 2018, Glenmark Pharmaceuticals and Helsinn Group (Helsinn), a Swiss pharmaceutical group focused on building quality cancer care products, announced that they have entered into an exclusive licensing agreement to introduce AKYNZEO in India and Nepal. AKYNZEO, an oral fixed combination of netupitant 300mg and palonosetron 0.5mg in capsule form, is used for prevention of Chemotherapy-induced Nausea and Vomiting (CINV). The licensing agreement with Glenmark for AKYNZEO represents Helsinn's first such agreement in India. Glenmark will have exclusive marketing rights for AKYNZEO in India and Nepal.
On 22 May 2018, Glenmark Pharmaceuticals announced that the company has submitted a New Drug Application (NDA) to the US Food & Drug Administration (FDA) for its leading respiratory pipeline candidate Ryaltris, an investigational fixed-dose combination nasal spray of an antihistamine and a steroid, as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older. Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg), formerly GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name.
On 19 June 2018, Glenmark Pharmaceuticals announced that the US Food & Drug Administration provided its first supplemental Abbreviated New Drug Applications (ANDA) approval for the company's manufacturing facility in Monroe, North Carolina. The approval covers: Atovaquone and Proguanil Hydrochloride Tablets, 250 MG/100 MG and 62.5 MG/25 MG, a generic version of GlaxoSmithKline's Malarone (atovaquone and proguanil hydrochloride) Tablets. The Monroe, North Carolina facility is Glenmark's first manufacturing site in the US, designed to manufacture a variety of fixed dose pharmaceutical formulations. Glenmark has invested more than $100 million into the facility with plans for further expansion in the coming years. At peak capacity, the site is anticipated to produce 300-400 million tablets and capsules, 20-25 million vials and pre-filled syringes and 25-30 million ampoules for inhaled formulations.
During the F.Y. 2017-18 Glenmark Pharmaceuticals Singapore Pte. Ltd. was formed as the wholly owned subsidiary of the company
In FY18, Glenmark was granted approval of 21 Abbreviated New Drug Applications (ANDA), comprising 18 final approvals and three tentative approvals. Notable approvals include Aprepitant Capsules USP, Atomoxetine Capsules USP, Nitroglycerin Sublingual Tablets and Propafenone Hydrochloride Extended-Release Capsules USP. The Company filed a total of 16 ANDA applications with the US FDA throughout the fiscal year.
During the year 2018, Glenmark launched Dermikelp, VWash Plus, Tacroz and Tacroz F in Zambia; Tacroz and Telma H in Tanzania; Ascoril D, Teneligliptin and its combination with Metformin in Mauritius, Momate F in Uganda and Sertaconazole (Onabet) in Sudan.
During the year 2018, Glenmark launched Tacroz, Dosetil and Momate NS in Philippines; Momate NS, Dermikelp and VWash in Malaysia and Konzert in Cambodia in the Asia region.
As on March 31 2018, the Company has filed over 370 Global DMFs in various markets, including 103 USDMFs, 28 CEPs, 40 EU- DMFs, 22 Canadian DMFs, 12 Japan DMFs, 13 Australian DMFs and other DMFs in various Rest-of-the-World (ROW) countries.
During the year 2018, NebZmart, NebZsol and Vocety were launched in Brazil. In Colombia, the Company strengthened its dermatology portfolio and introduced Glenpalene, Glenpalene C, Dermotil S, Glencort, Butemax and Clotridid. Momate AZ nasal spray was launched in the Caribbean region and Glenmark is the first generic alternative in the market offering this unique combination.
In FY18, Momate Rhino Advance, a unique combination of mometasone + azelastine nasal spray on the local market, was launched in Uzbekistan and is indicated for the treatment of patients with seasonal allergic rhinitis. Momat Rino 60 and 120 doses nasal sprays were also launched in Uzbekistan. During the year, Glenmark launched Glenspray (mometasone) 50 mcg/120 doses and Glenspray (mometasone) 50 mcg/60 doses in Ukraine.
During the year 2018, Glenmark also successfully concluded the US FDA audit of the API plant at Mohol and is awaiting the EIR from the agency.
During the year 2018-19, the Company acquired 100% stake in Zorg Laboratories Private Limited (Zorg) for an aggregate consideration of 5 lacs before adjustments and subject to legal and financial due diligence. Subsequently, name of Zorg was changed to Glenmark Life Sciences Limited (GLS). The shareholders of the Company approved the transfer of its Active Pharmaceuticals Business (API) to GLS by passing a resolution through postal ballot.
During the FY2019, the Company had entered into a collaboration with leading, home-grown private equity firm True North Enterprise Private Limited (True North') and transferred its Orthopaedic and Pain management business valued at Rs 635 crore to Integrace Private Limited, a subsidiary of True North. Integrace will market the product portfolio in India and Nepal.
As on 31 March 2019,the company has 42 subsidiary companies under its roof.
The Company filed a total of 13 ANDAs with the USFDA during the financial year. In FY 2018-19, Glenmark was granted approval for 25 Abbreviated New Drug Applications (ANDA), comprising of 20 final approvals and 5 tentative approvals.
During the year, the company bagged CII Safety Health and Environmental Excellence and Innovation Award 2018 for the Indore facility.
During the FY2020,the Company had entered into Business Transfer Agreement with Integrace Private Limited for transfer Company's Gynaecology business, valued at Rs 115 crore.
During the year, the Company entered into definitive agreement with Hindustan Unilever Limited for divestment of VWash franchise comprising VWash Plus Intimate Hygiene Wash, VWash WOW, VWash Plus Bikini Line, VWash Plus wipes and other such assets globally including the associated trademarks, brand names and certain business contracts.
It launched a globally researched innovator molecule, Remogliflozin in FY 2019.
As on 31 March 2020, the company has 44 subsidiary companies under roof. It introduced a fixed-dose combination of Remogliflozin Etabonate and Vildagliptin in 2020. It also launched a fixed-dose combination of Remogliflozin+Metformin under the brand names Remo-M and Remo-Zen M.
Glenmark Life Sciences Limited, a wholly owned subsidiary of the Company on 16th April 2021 has filed a draft red herring prospectus with the Securities and Exchange Board of India for an initial public offer, comprising of a fresh issue of up to Rs. 11,600 million and an offer for sale of up to 7,305,245 equity shares of Rs. 2 each of Glenmark Life Sciences Limited, by Glenmark Pharmaceuticals Limited. The !PO will be subject to market conditions, receipt of applicable approvals and other considerations.
In the fiscal year 2020-21, Glenmark was granted approval of 14 ANDAs comprised of 10 final approvals and 4 tentative approvals. Additionally, it was granted approval on a Prior Approval Supplement (PAS) for the 0.25 mg strength for Fingnolimod Capsules. Notable approvals include: Sirolimus Tablets, Tacrolimus Capsules USP, Topiramate Extended-Release Capsules USP, Chlorpromazine Hydrochloride Tablets USP and Diltiazem Hydrochloride Extended-Release Capsules USP. The Company filed a total of 7 ANDAs with the USFDA in FY21 and plan to file 18-20 ANDAs in FY22 including 5-6 filings which got delayed in FY21 due to the pandemic. During 2021, its subsidiary, Ichnos Sciences signed a licensing agreement with Almirall SA for the IL-1RAP antagonist ISB 880 for an upfront payment of EUR 20.8 Million. It received approval for 14 ANDAs that comprised 10 final approvals and 4 tentative approvals. It launched 10 new products in FY 2020-21. On 30th April, 2021, the Company made a strategic investment of Rs. 400 million in ABCD Technologies LLP .
During the year 2022, Company received US FDA's NDA approval for novel Ryaltris-AZ as a novel fixed dose with a steroid of Mometasone Furoate and Azelastine for the treatment of allergic rhinitis in adults and paediatric patients 12 years of age and older. It launched Tiotropium Bromide Dry Powder Inhaler (DPI) in UK. It launched Tavulus in Spain and Tiotropium in Germany. It also launched Beclometasone to provide asthma patients access to a high-quality, cost-effective inhaler. It launched Glendes in Malaysia for treatment of minor cases of allergy. In Brazil, it launched Salbutamol to relieve symptoms of asthma and chronic obstructive pulmonary disease (COPD) such as coughing, wheezing and feeling breathless. It launched Canditral- SB in India to treat fungal infections of the mouth, throat, toenails, fingernails or lungs. To treat the symptoms of LennoxGastaut Syndrome (seizures), it launched Rufinamide tablets in the USA. It collaborated with Canadian biotech firm SaNOtize Research & Development Corp. to manufacture, market and distribute its breakthrough Nitric Oxide Nasal Spray (NONS) for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam. It launched NONS under the brand name FabiSpray in February 2022, after receiving manufacturing and marketing approval from the Drugs Controller General of India (DCGI) as part of the accelerated approval process. Ichnos Sciences Inc., a subsidiary of Glenmark completed a EUR ~21 Million exclusive licensing agreement for the IL-1RAP antagonist ISB 880. Remogliflozin, Vildagliptin, Metformin, a Fixed Dose Combination (FDC) was launched during the year to enhance patient access to SGLT2 and DPP4 inhibitors for effective treatment of diabetes. FabiSpray was also launched in Singapore and Hong Kong under the brand name VirX. It introduced India's first Probiotic based product across its dermatology portfolio, such as Elovera Pro Cream and Elovera Pro Lotion. It launched 10 new products in the US taking total marketing portfolio in US 174 generic products authorized for distribution in the U.S. market. It entered into an agreement with AstraZeneca to commercialize its product, Pulmicort Respules in Colombia. Besides this, it entered into exclusive licensing agreement with Lotus International Pte. Ltd. for commercializing Ryaltris in Singapore, Hong Kong and Vietnam. Three new pharmaceutical modules became fully operational at its Ankleshwar facility.
During the year 2022-23, in the Respiratory segment, Glenmark became the first company in India to market Indamet - an innovative fixed drug combination of Indaceterol, a long-acting beta-agonist and mometasone, an inhaled corticosteroid, for the treatment of uncontrolled asthma. In the Diabetes segment, it launched sitagliptin under the brand name SITAZIT and its fixed dose combinations with metformin and dapagliflozin respectively; teneligliptin + pioglitazone Fixed-Dose Combination drug for Type 2 Diabetes under the brand name Zita Plus Pio; lobeglitazone 0.5mg, under the brand name LOBG; Fixed-Dose Combination (FDC) of Teneligliptin (20 mg) + Pioglitazone (15 mg) + Metformin (500mg/1000mg) SR under the brand name Zita-PioMet; Lobeglitazone + Metformin under the brand name LOBG-M. In the Cardio-Vascular segment, it launched Sacubitril + Valsartan under the brand name, Sacu V for the treatment of heart failure. New products such as La Shield Pollution Protect, La Shield Probiotic Moisturizer and Scalpe Pro Shampoo contributed to business growth in FY23.
Thereafter, in FY23, Glenmark launched 8 new products during the fiscal year 2022-23, consisting of a mix of immediate-release oral solids and an injectable. Notable launches include Ezetimibe Tablets USP; Abiraterone Acetate Tablets USP, 500 mg; Fingolimod Capsules, 0.5 mg; Sodium Phenylbutyrate Tablets USP, 500 mg; Nicardipine Hydrochloride Capsules; Bumetanide Injection, 1 mg/4 mL (0.25 mg/mL) Single-Dose Vials; and 2.5 mg/10 mL (0.25 mg/mL) Multi-Dose Vials, and Teriflunomide Tablets. It launched first generics, Teriflunomide (Aubagio) Tablets. It got into a distribution agreement with Cediprof for USFDA approved Mixed Amphetamines Immediate-Release Tablets.
As of March 31, 2023, Glenmark's marketing portfolio included 183 generic products authorized for distribution in the U.S. market. 4 new products were introduced in the market, including Fenismart(dimetindene) gel and Phelisans (phenasone + lidocaine) ear drops. It launched RYALTRIS in the Malaysian market in 4Q of FY23.
Glenmark Pharmaceuticals Ltd
Directors Reports
Glenmark Pharmaceuticals Ltd
Company Background
| Incorporation Year | 1977 |
| Registered Office | B/2 Mahalaxmi Chambers,22 Bhulabhai Desai Road
Mumbai,Maharashtra-400026 |
| Telephone | 91-22-40189999,Managing Director |
| Fax | 91-22-40189986 |
Glenn SaldanhaGlenn Saldanha| Company Secretary | |
| Auditor | Suresh Surana & Associates LLP |
| Face Value | 1 |
| Market Lot | 1 |
| Listing | BSE,MSEI ,NSE, |
| Registrar | KFin Techologies Ltd
Karvy Selenium Tow-B,31&32 Financial Dist,Nanakramguda ,Hyderabad-500032 |
Glenmark Pharmaceuticals Ltd
Company Management
| Director Name | Director Designation | Year |
|---|
| Gracias Saldanha | Chairman | 2008 |
| Glenn Saldanha | Chairman / Executive Director / M D / Promoter | 2023 |
| Glenn Saldanha | Managing Director & CEO | 2008 |
| Cheryl Pinto | Executive Director (Corporate) | 2023 |
| V S Mani | Executive Director & Group CFO | 2023 |
| Julio F Ribeiro | Director | 2008 |
| B E Saldanha | Non Executive Director | 2023 |
| Natvarlal B Desai | Director | 2008 |
| Rajesh Desai. | Independent Non Exe. Director | 2023 |
| M Gopal Krishnan | Director | 2008 |
| Devendra Raj Mehta | Independent Non Exe. Director | 2023 |
| Sridhar Gorthi | Director | 2008 |
| Bernard Munos | Independent Non Exe. Director | 2023 |
| Cheryl Pinto | Director | 2008 |
| Brian W Tempest | Independent Non Exe. Director | 2023 |
| Sridhar Gorthi | Independent Non Exe. Director | 2023 |
| A S Mohanty | Director | 2008 |
| Sona Saira Ramasastry | Independent Non Exe. Director | 2023 |
| M J Mendonza | Company Secretary | 2008 |
| Dipankar Bhattacharjee | Independent Non Exe. Director | 2023 |
| Sanjay Chowdhary | Joint Company Secretary | 2008 |
| V R Iyer | Independent Non Exe. Director | 2023 |
| D R Mehta | Additional Director | 2008 |
| B E Saldanha | Additional Director | 2008 |
Glenmark Pharmaceuticals Ltd
Listing Information
| Listing Information |
|---|
| BSE_500 |
| BSE_HC |
| CNX500 |
| BSEMID |
| CNXPHARMA |
| CNXSMALLCA |
| CNXALPHAIN |
| BSEALLCAP |
| SML250 |
| MSL400 |
| BSEMOI |
| NFTYMSC400 |
| NFTYSC50 |
| NFTYSC250 |
| NFTYHEALTH |
| NF500M5025 |
| NFTYTOTMKT |
| NFTYMIDSMH |
| NMIM503020 |
Glenmark Pharmaceuticals Ltd
Finished Product
| Product Name | Unit | Installed
Capacity | Production
Quantity | Sales
Quantity | Sales
Value |
|---|
| Sales | NA | 0 | 0 | 0 | 7991.982 |
| Other Operating Income | NA | 0 | 0 | 0 | 124.201 |
| Services | NA | 0 | 0 | 0 | 25.398 |
| Sale of Abbreviated New Drug | NA | 0 | 0 | 0 | 0 |
| Sale of Scrap and Others | NA | 0 | 0 | 0 | 0 |
| Export Incentives | NA | 0 | 0 | 0 | 0 |
| Bulk Drugs | Kg | 0 | 0 | 0 | 0 |
| Aerosol Spray | No | 0 | 0 | 0 | 0 |
| Injectables | Ltr | 0 | 0 | 0 | 0 |
| Liquid Orals | Ltr | 0 | 0 | 0 | 0 |
| Lotions | Ltr | 0 | 0 | 0 | 0 |
| Ointment | Kg | 0 | 0 | 0 | 0 |
| Solids & Powders | Kg | 0 | 0 | 0 | 0 |
| Tablets & Capsules | No | 0 | 0 | 0 | 0 |
| Inhaler Capsules | No | 0 | 0 | 0 | 0 |
| Pesticides | NA | 0 | 0 | 0 | 0 |
| Cardiac Division | Rs. | 0 | 0 | 0 | 0 |