Suven Pharmaceuticals’ wholly owned subsidiary -- Casper Parma has received EIR from US Food and Drug Administration (USFDA) for its pre-approval inspection (PAI). The pre- approval inspection was conducted during July 25, 2022 through July 29, 2022. The inspection concluded with no observation (FDA-483) issued. Pre-Approval Inspections covering of three applications: NDA 016084, ANDA 217020 and ANDA 217030.
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.
