USFDA completes inspection at Gland Pharma Visakhapatnam facility with Zero 483 observations
Telangana: Gland Pharma has informed in a BSE filing that the United States Food and Drug Administration (US FDA) has completed an inspection with Zero 483 observations at the Company’s API Facility at JNPC, Visakhapatnam.
The facility was inspected from May 20, 2024 to May 24, 2024.
"We wish to inform you that the United States Food and Drug Administration (US FDA) conducted an inspection at the Company’s API Facility at JNPC, Visakhapatnam from May 20, 2024 to May 24, 2024 and has been completed with Zero 483 observations,"
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Gland Pharma was established in 1978 in Hyderabad. The Company has grown over the years from a contract manufacturer of small-volume liquid parenteral products to a injectable-focused companies. Its global footprint is spread 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 has an excellent track record in developing, manufacturing, and marketing 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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