Drug firm Strides Shasun’s oral dosage facility in Bangalore has had successful inspection by the US health regulator with no adverse observations made.
The United States Food and Drug Administration (USFDA) has completed the inspection of the company’s oral dosage facility in Bangalore with ‘Zero 483s’, Strides Shasun said in a filing to BSE.
With the recently closed Establishment Inspection Report (EIR), the entire facility is now USFDA compliant, it added.
“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”, Strides Shasun said.
The Bangalore facility manufactures oral dosage forms including tablets, capsules, ointments and liquids, it added.
The plant supports current and future submissions for the US market, Strides Shasun said.
Strides Shasun has 14 manufacturing facilities including 6 USFDA approved facilities and 8 facilities for the emerging markets.