Gland Pharma Secures USFDA Approval For Generic Injectable

Gland Pharma said that it has got permission from the US Food and Drug Administration to manufacture a generic blood pressure medication. According to a regulatory filing, the Hyderabad-based business has acquired provisional clearance from the US Food and Drug Administration (USFDA) for Angiotensin II Injection , 2.5 mg/mL Single Dose Vial.The company believes that it is the only company with first to file for this product and may be eligible for 180 days of generic drug exclusivity, it added, as per economictimes.Gland Pharma said it will launch the medicine with its marketing partner once final permission is received. Angiotensin II Injection (2.5 mg/mL Single Dose Vial) has US sales of roughly USD 38 million for the fiscal year ending September 2023.On the BSE, shares of the pharmaceutical company were trading 0.68 percent down at Rs 1,613.35 apiece.Gland Pharma has evolved from a contract manufacturer [HK1] of small volume liquid parenteral products to one of the world's largest and fastest growing generic injectables manufacturers, with a global footprint spanning 60 countries, including the United States, Europe, Canada, Australia, India, and other markets.We typically operate on a business-to-business (B2B) basis and have a strong track record in pharmaceutical R&D production, and marketing of complicated injectables. This presence throughout the value chain has enabled us to experience exponential development. We have an experienced management team, and one of our Promoters, Shanghai Fosun Pharma, is a worldwide pharmaceutical conglomerate