Gland Pharma gets 2 USFDA observations for Dundigal facility
Telangana: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded a surprise inspection of the Company's Dundigal Facility at Hyderabad for Good Manufacturing Practices (GMP) with two 483 Observations.
Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and develops, manufactures, and markets sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.
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