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Zydus Cadila's Baddi facility receives US FDA nod

The company has also received US FDA approval for anti-depressant drug, mirtazapine

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Last Updated : Sep 28 2017 | 8:24 PM IST

Zydus Cadila's formulations manufacturing facility at Baddi (Himachal Pradesh) has received the establishment inspection report (EIR) from the US Food & Drug Administration (FDA). “The company’s formulations manufacturing facility at Baddi has received an establishment inspection report from the US FDA. This receipt of EIR indicates the successful closure of the inspection points (483s) raised based on the inspection carried out between February 21, 2017 to March 1, 2017,” said Zydus Cadila in a press release.

Meanwhile, Zydus Cadila has received the final approval from the US FDA to market mirtazapine orally disintegrating tablets in strengths of 15 mg, 30 mg and 45 mg. The approved drug, an anti-depressant, will be produced at the group's formulations manufacturing facility at Baddi.

With this, the group now has more than 115 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.