USFDA Inspecting Sun Pharma’s Injectibles Plant
The U.S. drug regulator is conducting a surprise inspection at Baska plant of Sun Pharmaceuticals Ltd. starting today, two people aware of the development told BloombergQuint requesting anonymity.
The Baska injectibles unit recently filed for approvals to sell its products in the U.S., Sun Pharma’s biggest market. It’s close to India’s largest drugmaker’s Halol plant that faces regulatory issues from the U.S. Food and Drug Administration.
Such an inspection typically lasts seven to eight working days, one of the people quoted above said. The company didn’t respond to BloombergQuint’s emailed queries on why the USFDA inspectors were at the site.
Sun Pharma will report its earnings for the quarter ended September tomorrow and the Street will be keenly watching commentary on inspection timelines for the Halol unit.