NEW DELHI, June 7: Drug firm Strides Shasun has received Establishment Inspection Report (EIR) from the US health regulator on closure of inspection of its oral dosage Facility at Bengaluru.
“The company’s Oral Dosage Forms manufacturing site (KRS Gardens) in Bengaluru which was inspected by the USFDA in February 2016 has received the EIR, thereby confirming the closure of the inspection. The facility continues to be USFDA approved,” Strides said in a BSE filing.
USFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed.
Strides’s KRS Gardens facility manufactures oral dosage forms including tablets, capsules (both hard and soft gelatine). The manufacturing plant supports important current and future submissions for the US market.
(PTI)
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