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Zydus gets US FDA tentative marketing nod for Pregabalin capsules

Our Bureau, Mumbai
Friday, December 1, 2017, 13:10 Hrs  [IST]

Zydus Pharmaceutical (USA) Inc., a wholly owned subsidiary of Cadila Healthcare Limited, has received the tentative approval from the US FDA to market Pregabalin capsules in strengths of 25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg.

Pregabalin is used for management of certain kinds of seizures, neuropathic pain (never pain) and fibromyalgia. It will be manufactured at the group's formulation manufactured facility at Moraiya, Ahmedabad.

The group now has more than 175 approvals and has so far filed over 310 ANDAs since the commencement of the filing process in FY 2003-04.


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