Glenmark Pharmaceuticals Ltd has received final approval from the US Food and Drug Administration (USFDA) for fluphenazine hydrochloride tablets USP in strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg. These tablets are the generic version of Prolixin tablets manufactured by Apothecon Inc.
Glenmark Pharmaceuticals Inc, USA, will handle the distribution of the fluphenazine hydrochloride tablets in the US.
As per IQVIATM sales data for the 12-month period ending September 2023, r Prolixin tablets recorded annual sales of about $18.1 million. Glenmark currently holds a portfolio of 189 products authorised for distribution in the US market, with 50 ANDAs pending approval by the USFDA.
The shares were up by 0.45 per cent to Rs 759 at 3 pm on BSE.