Strides Pharma Science on Friday said it has received an Establishment Inspection Report from the U.S. health regulator for its Bengaluru-based manufacturing facility.
The U.S. Food and Drug Administration issues an EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted scrutiny.
The company's flagship facility was inspected by the US FDA during Dec. 5-9, 2022, and a form 483 listing three inspectional observations was issued, Strides Pharma Science said in a regulatory filing.
Based on the company's response to the observations and subsequent commitments, the USFDA has classified the outcome of this inspection as voluntary action indicated, and the EIR states that the inspection is closed, it added.
The Bengaluru-based plant is the largest for the company. It rolls out finished formulation products across multiple dosage formats, including tablets, capsules, ointments, creams, and liquids.
The facility services key regulated markets of the U.S., Europe, and Australia, it said.
Shares of the company were trading 0.17% lower at Rs 298.30 apiece on the BSE.
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