Granules India up 2 per cent on USFDA approval

Granules India’s foreign arm, Granules Pharmaceuticals, Inc has received approval from USFDA for Abbreviated New Drug Application (ANDA) for methylphenidate hydrochloride extended-release capsules for 10 mg, 20 mg, 30 mg, 40 mg and 60 mg, which is bioequivalent to the reference listed drug product (RLD), Ritalin LA extended-release capsules of Novartis.

Methylphenidate hydrochloride extended-release capsules are used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The company has submitted a total 19 ANDAs out of which 16 are waiting for approval.

In the recently concluded quarter Q4FY19, the revenue mix stood at FD (47 per cent), API (36 per cent) and PFI (17 per cent). On the geographical front, revenue mix comprises of North America (54 per cent), Europe (19 per cent), India (15 per cent), LATAM (8 per cent) and ROW (4 per cent).

On Monday, the stock opened at Rs. 113, up by 2 per cent from its previous close of Rs. 110.60 on the BSE. At 10:06 hours, the stock was trading nearly at Rs. 112.60.