Strides Shasun Limited has announced successful completion of USFDA 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, said a company note.
The Oral Dosage facility (KRS Gardens facility) in Bengaluru 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.
The company has four business verticals: regulated markets, emerging markets, institutional business and pharmaceutical services & active ingredients. It has global manufacturing foot print with 14 manufacturing facilities spread across three continents including 6 US FDA approved facilities and 8 facilities for the emerging markets. In addition, it has three dedicated R&D facilities in India with global filing capabilities and a strong commercial footprint across 85 countries.