Strides Pharma said the US Food & Drug Administration completed an inspection of the company’s primary manufacturing facility in India with zero adverse observations.
The company’s formulations facility at KRSG Gardens in Bangalore was inspected by the USFDA for good manufacturing practices in August 2018 and November 2018.
Strides Pharma said it received the Establishment Inspection Report (EIR), which indicates the closure of the inspection process.
“The inspection conducted in November 2018 had concluded with Zero 483 observations,” it said.
Closure of an inspection with zero observations is considered an achievement as a large number of inspections tend to generate one or two observations, which are subsequently addressed using mitigation measures.
Strides’ flagship facility in Bangalore manufacturers tablets, capsules, liquids, creams ointments, sachets.
It is the largest for company and supports several current and future products for the US markets.
Incorporated in 1990, Strides Pharma Science Limited is a global pharmaceutical Company headquartered in Bangalore and has two business divisions — Regulated Markets and Emerging Markets.
It has seven manufacturing facilities spread across three continents including 5 US FDA approved facilities and 2 facilities for the emerging markets.
The Company has a dedicated R&D facility in India with global filing capabilities and a strong footprint across 100 countries.