Apitoria Pharma Private Limited Unit 1

CLOSEOUT LETTER Apitoria Pharma Private Limited Unit 1 MARCS-CMS 618091 — November 13, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: FEI 3004021253 Product: Drugs Recipient: Recipient Name Dr. Sanjay Chaturvedi Recipient Title Chief Executive Officer Apitoria Pharma Private Limited Unit 1 Floor No.’s 22, 23, & 24. Galaxy, Plot No-1, Survey no: 83/1 Knowledge City, Raidurg Hyderabad 500032 Telangana India sanjay@apitoria.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Dr. Chaturvedi: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning 320-22-10 dated January 12, 2022. 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/ Daniel W. Brisker Compliance Officer Division of Drug Quality II Content current as of: 11/17/2025 Regulated Product(s) Drugs