Zydus Lifesciences’ (including its subsidiaries/affiliates hereafter referred to as Zydus) subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) for Gabapentin Tablets (Once-Daily), 300 mg and 600 mg (USRLD: Gralise Tablets).
Gabapentin tablets are indicated for the management of Postherpetic Neuralgia (PHN). The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya. Gabapentin Tablets had annual sales of $90 million in the United States.
The group now has 343 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
