Unichem Lab gets FDA approval pain management drug

Unichem Lab gets FDA approval for pain management drug

10:25 AM, 14th August 2019
Unichem Laboratories logo

NEW DELHI, INDIA: Unichem Laboratories has received Abbreviated New Drug Application (ANDA) approval from US Food & Drug Administration (USFDA), for Tramadol Hydrochloride tablets.

Tramadol Hydrochloride tablets are indicated as a pain management drug in adults. The approved product is a generic version of Ultram tablets of Janssen Pharmaceuticals Inc. 

Unichem said that the product will be commercialised from its Ghaziabad, Uttar Pradesh, India plant.

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