Gland Pharma Ltd

History of Gland Pharma Ltd

Gland Pharma Limited was incorporated as Gland Pharma Private Limited', a private limited company on March 20, 1978 and was granted the certificate of incorporation by Registrar of Companies, Andhra Pradesh at Hyderabad. Subsequently, the name of the Company was changed to Gland Pharma Limited' and a fresh certificate of incorporation dated April 25, 1995 was issued by the Registrar of Companies, Andhra Pradesh at Hyderabad. The Company is primarily engaged in manufacturing injectable formulations. Established in Hyderabad, India, Company has evolved into a prominent entity in the global generic injectables market, with operations extending to over 60 countries including the United States, Europe, Canada, Australia, and India. Primarily functioning under a B2B model, the company provides comprehensive services such as contract development, dossier compilation, technology transfer, and manufacturing across various delivery systems. Over the years, the company has made substantial investments in the companies manufacturing infrastructure to support the product portfolio needs and reach. The company has seven manufacturing facilities in India, comprising four finished formulations facilities with a total of 42 production lines and three API facilities. The companies API facilities provide with in-house manufacturing capabilities for critical APIs, enabling the company to control costs and quality and mitigate supply chain related risks around the key products. The companie ...s capabilities as a vertically integrated company include internal research and development (R&D) expertise, robust manufacturing capabilities, a strict quality assurance system, extensive regulatory experience and established marketing and distribution relationships. As of March 31, 2020, the company along with partners had 265 ANDA filings in the United States, of which 204 were approved and 61 were pending approval. The 265 ANDA filings comprise 189 ANDA filings for sterile injectables, 50 for oncology and 26 for ophthalmics related products. Out of these 265 ANDA filings, 100 represent ANDAs owned by the company, of which 63 ANDA filings are approved and 37 are pending approval. As of the same date, the company along with partners had a total of 1,415 product registrations, comprising 368 product registrations in the United States, Europe, Canada and Australia, 54 in India and 993 in the Rest of the world. The company also has a consistent regulatory compliance track record and all the facilities are approved by the USFDA from whom the company have had no warning letters since the inception of each facility. Other key regulatory agencies for which certain of our facilities have approvals include MHRA (UK), TGA (Australia), ANVISA (Brazil), AGES (Austria) and BGV Hamburg (Germany). During the year 2020-21, the Company has incorporated Gland Pharma International Pte. Ltd., a Wholly-owned Subsidiary in Singapore. It has incurred capital expenditure of Rs. 2,287.76 million at its manufacturing facilities at Dundigal, Pashamylaram, VSEZ and Pharmacity. It has issued and allotted 8,333,333 fully paid-up equity shares in the Initial Public Offer during November, 2020. During FY 2022, the Company launched 47 product SKUs of 28 molecules like Micafungin, Ziprasidone, Bivalirudin RTU and Olapatadine Ophthalmic (OTC). As of March 31, 2022, it along with the partners had 284 ANDA filings in the US, of which 234 were approved and 50 were pending approval. Out of these, 115 were owned by the Company with 85 approvals and 30 pending for approval. It had manufacturing capacity for finished formulations of approximately 767 million units per annum. It filed 21 ANDAs, 5 DMFs and received 32 ANDA approvals. It signed an agreement to supply upto 252 million doses of RDIF's Sputnik V COVID-19 vaccine. It purchased assets of Vitane Biologics, Hyderabad based biopharmaceutical company. On 27th April, 2023, Gland Pharma International Pte. Ltd., Wholly Owned Subsidiary of the Company acquired Phixen SAS and 3 holding companies in Cenexi for a purchase consideration costing Euro 114,259,004.44 and repaid a loan of Euro 79,457,194.11 on behalf of the Sellers through Share Purchase Agreement dated 6th January, 2023 and as a result, Phixen SAS and the Cenexi Holding Entities became the Wholly Owned step-down Subsidiaries of the Company, which in turn resulted in indirect acquisition of 7 subsidiaries of Cenexi, a) Cenexi SAS, (b) Cenexi Services SAS, (c) Cenexi HSC SAS, (d) Cenexi 2 SASU, (e) Cenexi 3 SASU, (f) Cenexi Laboratories Thissen SA and (g) Phineximmo SA. 'Dexrazoxane' the first product was launched in China during the year 2023. The Company launched Eribulin as its first major complex product in May, 2024. The Company commissioned a new high-capacity ampoule line, adding an annual capacity of 40 to 50 Million units at Fontenay, France in FY 2025.