Gland Pharma gets one USFDA observation for Pashamylaram Facility
Hyderabad: Gland Pharma has recently announced that the US Food and Drug Administration (USFDA) has concluded the inspection at the company's Pashamylaram Facility with one 483 Observation.
The Pre-Approval Inspection (PAI) for Seven (7) Products and Good Manufacturing Practice (GMP) Inspection at the Company’s Pashamylaram Facility at Hyderabad has been conducted by USFDA between 15th June 2023 and 27th June 2023.
"This observation is procedural in nature and the corrective and preventive actions for this observation will be submitted to the US FDA within the stipulated period. The observation issued is neither a repeated observation nor related to data integrity," the company stated in a BSE filing.
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Gland Pharma, a generic injectable-focused pharmaceutical company was established in 1978 in Hyderabad. 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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