Granules India rises on receiving USFDA approval for Penicillamine capsules

Granules India, a Hyderabad-based pharmaceutical company, announced on Thursday that it has received approval from United States Food & Drug Administration (USFDA) for Penicillamine capsules USP, the abbreviated new drug application (ANDA).

Penicillamine capsules USP, 250 mg is bioequivalent to Cuprimine of Bausch Health Americas, Inc. The capsules are used in the treatment of Wilson's disease, Cystinuria, and also in patients with severe, active rheumatoid arthritis, who have failed to respond to an adequate trial of conventional therapy.

The manufacturing of the drug will take place at the company’s manufacturing facility in Chantilly (Virginia) and its launch is expected soon.

According to IQVIA Health for the most recent twelve months ending in October 2020, Penicillamine capsules had recorded US sales of approximately USD 67 million.

Granules India is engaged in the manufacturing of active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs). On the revenue front, it earns 52 per cent from FDs, 31 per cent from API, 16 per cent from PFI, and 1 per cent from other services.

At 2:21 pm on Friday, its share was trading higher by 0.73 per cent at Rs 422.50. It recorded an intraday high of Rs 430 and an intraday low of Rs 422.50 on BSE.