Torrent Pharmaceuticals Limited

CLOSEOUT LETTER Torrent Pharmaceuticals Limited MARCS-CMS 585255 — September 04, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3005029956 Product: Drugs Recipient: Recipient Name Mr. Jinesh Shah Recipient Title Director and Board of Director Torrent Pharmaceuticals Limited Taluka-Kadi, Ahmedabad Mehsana Highway Indrad 382721 Gujarat India Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Shah: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-20-03 dated October 8, 2019. Based on our evaluation, it appears that you have addressed the violations 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 violations or deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Bryce Hammer Compliance Officer Division of Drug Quality II Content current as of: 09/06/2024 Regulated Product(s) Drugs