US FDA successfully completes Strides Shasun’s facility inspection

The oral dosage facility in Bengaluru is now US FDA compliant

Strides Shasun has announced successful completion of US FDA inspection at its flagship oral dosage facility in Bengaluru with ‘Zero 483s.’ The audit was carried out related to a product filed from the new semi solids block from where the company has made a series of filings.

With the recently closed Establishment Inspection Report (EIR) announced on June 7, 2016, the entire facility is now US FDA compliant. The oral dosage facility (KRS Gardens facility) in Bangalore manufactures oral dosage forms including tablets, capsules (both hard gelatine and soft gelatine), ointments and liquids. The manufacturing plant supports important current and future submissions for the US market.