Gland Pharma Ltd

Gland Pharma Ltd

Gland Pharma Ltd was incorporated as `Gland Pharma Private Limited' a private limited company under the Companies Act 1956 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' pursuant to a special resolution passed by the shareholders of the Company on December 5 1994 and a fresh certificate of incorporation dated April 25 1995 was issued by the Registrar of Companies Andhra Pradesh at Hyderabad consequent upon change of name and conversion into a public limited company under the Companies Act 1956. The Company is primarily engaged in manufacturing injectable formulations.The company is one of the fastest growing generic injectables-focused companies by revenue in the United States from 2014 to 2019. The company has 8 manufacturing facilities in India comprising four finished formulations facilities with a total of 23 production lines and three API facilities. The company sells products primarily under a business to business (B2B) model in over 60 countries as of March 31 2022 including the United States Europe Canada Australia India and the Rest of the world. The company has a consistent compliance track record with a range of regulatory regimes across these markets. The company also have an extensive track record in complex injectables development manufacturing and marketing and a close understanding of the related sophisticated scientific technical and regulatory processes. The company has expanded it nature of business from liquid parenterals to cover other elements of the injectables value chain including contract development own development dossier preparation and filing technology transfer and manufacturing across a range of 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 22 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 companies 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 1415 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. 2287.76 million at its manufacturing facilities at Dundigal Pashamylaram VSEZ and Pharmacity. It has issued and allotted 8333333 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 114259004.44 and repaid a loan of Euro 79457194.11 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.