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Sun Pharma gets one observation from USFDA for Baska plant


Sun Pharma gets one observation from USFDA for Baska plant
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.
 
New Delhi: 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.

As per the USFDA, an FDA Form 483 is issued to a firm’s management at the conclusion of an inspection “when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.”

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.

Read Also: NPPA fixes retail price of Sun Pharma Baclofen Oral Solution

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Farhat Nasim

Farhat Nasim

Farhat Nasim joined Medical Dialogue as Reporter in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier's College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751


Source: PTI
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