U.S Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) in relation to the inspection of Strides Pharma Science’s flagship facility in Bangalore, India. The Company’s flagship facility was inspected by the USFDA between December 5 and 9, 2022, and a form 483 listing three inspectional observations was issued. Based on the Company’s response to the observations and subsequent commitments, the USFDA has classified the outcome of this inspection as VAI (voluntary action indicated), and the EIR states that the inspection is closed.
The flagship facility in Bangalore is the largest manufacturing facility for the company, with the capability to produce finished dosage formulation products across multiple dosage formats, including tablets, capsules, ointments, creams, and liquids. The facility services the key regulated markets of the US, Europe, and Australia.
Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world’s largest manufacturers of soft gelatin capsules.
