Centaur Pharmaceuticals Private Ltd.

CLOSEOUT LETTER Centaur Pharmaceuticals Private Ltd. MARCS-CMS 651080 — December 03, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3003973520 Product: Drugs Recipient: Recipient Name Santosh Badhe Recipient Title Vice President Centaur Pharmaceuticals Private Ltd. Plot No. 75, 76 & 76/1, & 74 Chikhloli MIDC Ambernath-West Thane 421501 Maharashtra India Issuing Office: Center for Drug Evaluation and Research | CDER United States Secondary Issuing Offices United States Dear Mr. Badhe: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-15 dated June 5, 2023. Based on our evaluation, it appears that you have addressed the deviations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Matthew Jensen Compliance Officer Division of Drug Quality I Content current as of: 07/21/2026 Regulated Product(s) Drugs