Jubilant Generics Limited

CLOSEOUT LETTER Jubilant Generics Limited MARCS-CMS 569799 — April 23, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: 3006895982 Product: Drugs Recipient: Recipient Name Dr. Jaidev Sanjeev Rajpal Recipient Title Managing Director & CEO Jubilant Generics Limited Plot No. 15, Knowledge Park – II Greater Noida 201306 Uttar Pradesh India Issuing Office: Center for Drug Evaluation and Research | CDER United States Secondary Issuing Offices United States Dear Dr. Rajpal The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-15 dated March 6, 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 be observed during a subsequent inspection or through other means. Sincerely, /S/ Marisa Heayn Compliance Officer Division of Drug Quality II Content current as of: 05/01/2024 Regulated Product(s) Drugs