Gland Pharma has announced that its Pashamylaram facility has received a Good Manufacturing Practices (GMP) Compliance Certificate from the Danish Medicines Agency. This certification is crucial for marketing authorizations involving manufacturers outside the European Economic Area (EEA).
The approval specifically covers the company’s aseptically prepared powder products used for injection, infusion, and inhalation. The recognition underscores Gland Pharma’s commitment to maintaining global manufacturing standards and strengthens its position in international markets.
In the exchange filings, the company shared, “This is to inform you that the Pashamylaram Facility of the Company has received certificate of Good Manufacturing Practices (GMP) Compliance from Danish Medicines Agency in connection with Marketing authorizations listing manufacturers located outside of the European Economic Area, for aseptically prepared Powder for injection, infusion and inhalation.”
This GMP certification will enable Gland Pharma to continue expanding its reach in Europe and support the export of critical injectable and inhalable formulations.
