Gland Pharma arm Fontenay facility gets 10 observations from France drug regulator
Telangana: Through a recent BSE filing, Gland Pharma has informed that its material subsidiary, Cenexi's Fontenay manufacturing facility gets ten observations from the Agence nationale de sécurité du médicament et des produits de santé (ANSM), France, at the conclusion of a Good Manufacturing Practices (GMP) inspection
The facility was inspected between December 9th to 19th, 2024.
"The said inspection was concluded, and the Facility received an official notification on December 24, 2024, citing 10 (TEN) observations," the Company stated.
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.
