Strides Pharma Science Ltd. said the inspection of its formulation facility in Bengaluru by the U.S. health regulator has been completed successfully, with a voluntary action indicated classification.
The company's facility underwent a U.S. Food and Drug Administration inspection that ended on May 24, the drugmaker said in a statement.
The Bengaluru facility is the largest manufacturing facility for the company with capabilities to produce finished dosage formulation products across multiple dosage formats including tablet, capsules, ointments, creams and liquids, Strides Pharma said.
The facility services key regulated markets of the U.S., Europe, and Australia, it said.
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