Gland Pharma gets quality certification from Danish regulator for Pashamylaram facility

Gland Pharma’s Pashamylaram facility was awarded a Good Manufacturing Practices (GMP) Compliance Certificate on Friday (July 11) by the Danish Medicines Agency.This certification applies to marketing authorisations for manufacturers outside the European Economic Area and specifically covers aseptically prepared powder formulations for injection, infusion and inhalation.

In a separate development, the company’s Visakhapatnam facility, which earlier this year underwent a pre-approval inspection (PAI) by the US Food and Drug Administration (FDA), has received an Establishment Inspection Report (EIR)

from the agency on June 24.
The inspection took place between December 9 and December 19, 2024. Following the inspection, Cenexi submitted a comprehensive Corrective and Preventive Action (CAPA) plan, outlining a series of measures scheduled for implementation over a period ranging from three to twelve months, depending on the specific nature of each observation.The regulatory authority reviewed and accepted the proposed action plan. Gland Pharma confirmed that these observations would not interfere with or disrupt the ongoing manufacturing operations at the facility.

The announcement came after the close of the market hours. Shares of Gland Pharma Ltd ended at ₹1,857.90, up by ₹15.30, or 0.83%, on the BSE.

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