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USFDA conducts pre-approval inspection for J B Chemicals & Pharmaceuticals

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Issues four minor observations

J B Chemicals & Pharmaceuticals announced that the company went through USFDA per-approval inspection for ANDA filed for a capsule product. The said inspection was carried out from 15 October 2018 to 18 October 2018 at the company's solid oral manufacturing facility at Panoli, Gujarat. At the end of the inspection, USFDA has issued four minor observations. The company proposes to address these observations within next 15 days. These observations will not have any impact on the current business and will facilitate ANDA of capsule product that is already filed.

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First Published: Oct 19 2018 | 12:23 PM IST

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