Glenmark Pharmaceuticals Limited

CLOSEOUT LETTER Glenmark Pharmaceuticals Limited MARCS-CMS 637314 — September 23, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3004672766 Product: Drugs Recipient: Recipient Name Mr. Ganpat Sonybapu Pote Recipient Title VP Operation & Site Head Glenmark Pharmaceuticals Limited Plot No S - 7, Colvale Industrial Estate Colvale 403513 Goa India Ganpat.Pote@glenmarkpharma.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Pote: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-23-04 dated November 22, 2022. 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 be observed during a subsequent inspection or through other means. Sincerely, VILMARY NEGRON RODRIGUEZ -S Digitally signed by VILMARY NEGRON RODRIGUEZ -S Date: 2026.09.23 08:43: Vilmary Negrón Rodríguez Compliance Officer Division of Drug Quality I Content current as of: 10/05/2026 Regulated Product(s) Drugs