JB Chemicals gets zero USFDA observations for Panoli unit

The US Food and Drug Administration (USFDA) has concluded inspection of company's newly set-up and commissioned solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat, JB Chemicals & Pharmaceuticals said in a BSE filing.

New Delhi: JB Chemicals & Pharmaceuticals Wednesday said the US health regulator has concluded inspection of its manufacturing facility at Panoli in Gujarat without any observations.

The US Food and Drug Administration (USFDA) has concluded inspection of company's newly set-up and commissioned solid oral dosage forms formulations manufacturing facility at Panoli, Gujarat, JB Chemicals & Pharmaceuticals said in a BSE filing.

The said inspection was carried out from June 24-28, 2019, the company said.

A Form 483, is issued by the USFDA to notify a company's management of any objectionable condition at its manufacturing facility. The form is issued after completing the inspection.

JB Chemicals & Pharmaceuticals said this facility has the capacity of two billion tablets per annum, which is expandable to nine billion tablets per annum.

The company said the new facility will augment its manufacturing capacity for regulated markets like the USA and the EU, as and when the product approvals are received.

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