Zydus Cadila's Baddi facility receives US FDA nod

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.