Gland Pharma gets 3 USFDA observations for Pashamylaram facility

Hyderabad: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded an inspection of the Company's Pashamylaram Facility at Hyderabad for Good Manufacturing Practices (GMP) with three 483 Observations.

The un-announced inspection was conducted between 25 th July, 2024 and 02nd August, 2024.

"These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity," the Company stated in a BSE filing.

Medical Dialogues team had earlier reported that the Company had received an Establishment Inspection Report (EIR) from the US FDA indicating the closure of the inspection at the said facility.

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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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