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USFDA completes inspection of J B Chemicals Panoli facility with two observations


USFDA completes inspection of J B Chemicals Panoli facility with two observations

New Delhi: J B Chemicals and Pharmaceuticals said the US health regulator has completed inspection of its Panoli facility in Gujarat with two minor observations.

“The company’s API manufacturing facility at Panoli, Gujarat has successfully passed periodical inspection by US Food and Drug Administration (USFDA) with two minor procedural observations,” J B Chemicals and Pharmaceuticals said in a BSE filing.

The company said these observations do not impact continuity of its business and it would continue its manufacturing activities in Current Good Manufacturing Practice (CGMP) compliant manner.

“The company proposes to address these observations in next 30 days,” it added.

The inspection was carried out from May 7 to May 11, 2018.

This US FDA/EU/Japan approved API facility primarily manufactures APIs for exports to EU and formulations exports to US, it said.



Source: PTI
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