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Sun Pharma gets FDA observation for Baska plant
Highlights
New Delhi: Drug major Sun Pharma on Monday said it has received one observation from the US health regulator for its Baska manufacturing facility in...
New Delhi: Drug major Sun Pharma on 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.
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