Unichem gets observation from USFDA for Ghaziabad facility

The United States Food and Drug Administration (USFDA) conducted inspection at the Unichem Laboratories’ Ghaziabad formulation facility between August 19-23, 2019.

The inspection was a routine GMP surveillance. At the end of inspection, the facility received one observation which is not a repeat observation and is procedural in nature.

Unichem will provide the response and corrective action plan within next 15 working days to address the USFDA observation.

Earlier this month, the company had received ANDA approval from USFDA for Unichem's Tramadol Hydrochloride Tablets USP, 50 mg. to market a generic version of Ultram Tablets, 50 mg, of Janssen Pharmaceuticals, Inc. which are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Also, Unichem had received ANDA approval from USFDA for its Chlorthalidone Tablets USP, 25 mg and 50 mg to market a generic version of Hygroton Tablets, 25 mg and 50 mg of Sanofi Aventis US, LLC.

On Monday, the stock of Unichem Lab opened at Rs. 171.15 on BSE. In the early trading session, it was down by 3.3 per cent to Rs. 166.90.