Glenmark Generics gets USFDA nod for Ropinirole Hydrochloride
Glenmark Generics, (GGI) USA, a subsidiary of Glenmark Generics (GGL), has received ANDA approval from the United States Food and Drug Administration (USFDA) for Ropinirole Hydrochloride tablets 0 .25 mg, 0 .5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 5 mg.
The company will immediately commence marketing and distribution the approved product. Ropinirole Hydrochloride tablet is the generic version of GSK` s Requip® tablet in the US market.
Ropinirole hydrochloride is indicated for treatment of the signs and symptoms of idiopathic Parkinson`s disease as well as the treatment of moderate to severe primary restless leg syndrome (RLS).
Total sales for Ropinirole Hydrochloride tablets in the twelve month period ending December 2009 were USD 104 million , as reported by IMS Health.
Shares of Glenmark Pharmaceutical (Q,N,C,F)* gained Rs 6.45, or 2.56%, to trade at Rs 258.05. The total volume of shares traded was 138,426 at the BSE (1.43 p.m., Tuesday).
March 04, 2010