Gland Pharma gets 3 USFDA observations for Visakhapatnam facility
Hyderabad: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection with three observations at the Company’s Facility at JNPC, Visakhapatnam.
A Pre-approval inspection (PAI) for Sterile APIs was held between February 19, 2025 and February 25, 2025.
Conclusion of US FDA Inspection at Company’s JNPC Facility, Visakhapatnam
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.
Read also: USFDA completes inspection at Gland Pharma Visakhapatnam facility with Zero 483 observations
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