Jan 19, 2022 09:07 AM
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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 sells products primarily under a business to business (`B2B`) model in over 60 countries as of March 31, 2020, 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. As of March 31, 2020, the company had manufacturing capacity for finished formulations of approximately 755 million units per annum. 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 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).
|AGM Date (Month)||:||Aug|
|Face Value Equity Shares||:||1|
|Market Lot Equity Shares||:||1|
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