NEW DELHI, Mar 25: Drug major Sun Pharma Monday said it has received one observation from the US health regulator for its Baska manufacturing facility in Gujarat.
In a regulatory filing, the Mumbai-based company said the US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) of Baska facility from January 28 to February 5, 2019.
“At the conclusion of the inspection, the USFDA issued a Form 483, with one observation for which the company has submitted the response,” it added.
The Baska injectibles plant had recently filed for approvals to sell its products in the US, which is currently Sun Pharma’s biggest market. The manufacturing plant is located near the company’s Halol plant which is already facing regulatory issues from the US health regulator.
(PTI)
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