US Food & Drug Administration (US FDA) has completed Pre-Approval Inspections (PAI) and Good Manufacturing Practices (GMP) inspections at Suven Pharmaceuticals’ Active Pharmaceutical Ingredients (API) and Formulations facilities (Unit-3 and Unit-5, respectively) in Pashamylaram, Hyderabad, India. The inspections were conducted from February 12, 2024, to February 23, 2024. No Form 483 has been issued as a result of the inspection.
Suven Pharmaceuticals is a bio-pharmaceutical company, incorporated with the object of being engaged in the business of development and manufacturing of New Chemical Entity (NCE) based Intermediates, Active Pharmaceutical Ingredients (API), Speciality Chemicals and formulated drugs under contract research and manufacturing services for global pharmaceutical, biotechnology and chemical companies.
