Gland Pharma arm Fontenay facility gets 10 observations from France drug regulator

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-12-26 06:00 GMT | Update On 2024-12-26 06:00 GMT

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.

"Cenexi is committed to working closely with the ANSM to address the observations and will provide further updates to the exchanges as they become available," it added.

Medical Dialogues team had earlier reported that the United States Food and Drug Administration (US FDA) had concluded an inspection of the Company's Pashamylaram Facility at Hyderabad for Good Manufacturing Practices (GMP) with three 483 Observations.

Read also: USFDA nod to Gland Pharma Vitamin K deficiency treatment drug

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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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Gland Pharma arm Fontenay facility gets 10 observations from France drug regulator

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