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JB Chem gets US FDA nod for Panoli drug unit

Our Bureau

Mumbai , Jan. 12

IN a development that would help the Mumbai-based JB Chemicals & Pharmaceuticals Ltd step up activity in the US generic drugs market, the company today said that it had received approval from the US regulatory authorities for its manufacturing facility at Panoli, Gujarat.

The US Food and Drug Administration (FDA) has given its approval to the Panoli plant for manufacturing tablet dosage forms for the US market, the company told the BSE.

The US FDA inspected the company's manufacturing plant in October 2003, following which it classified the plant as acceptable for the US market, according to a company communiqué. The plant at Panoli is equipped to manufacture various tablet dosage forms and the approval enables the company to explore the US market more effectively and speedily, it added. It would also facilitate future abbreviated new drug applications (ANDA) submitted in global markets. To expand its exports, the company is exploring high-growth regulated markets such as Europe, the UK and South America, besides the US.

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