Strides Shasun has successfully completed US Food and Drug Administration (USFDA) inspection at its flagship oral dosage facility in Bangalore 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 USFDA 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.
Strides Shasun (formerly known as Strides Arcolab) is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures wide range of IP-lead niche pharmaceutical products with an emphasis on sterile injectables.