Share Market Live

NSE

Aurobindo Pharma has received tentative approval from the United States Food and Drug Administration (USFDA) for Dimethyl Fumarate capsules, which are used for the treatment of multiple sclerosis. The approval from the USFDA has been received for 120 mg and 240 mg capsules.

Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Tecfidera Delayed-Release Capsules, 120 mg and 240 mg, of Biogen Inc.

Dimethyl fumarate is used to treat relapsing forms of multiple sclerosis in adults. This includes clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

The USFDA granted tentative approval as the final approval was not granted due to the patent issue.

Last month, Aurobindo Pharma's wholly owned subsidiary Eugia Pharma Specialities received final approval from the US drug regulator for Amphotericin B Liposome injection, which is used for treating fungal infections.

Besides, the company's subsidiary Acrotech Biopharma entered into a license agreement with global biopharmaceutical company Evive Biotech to commercialise Ryzneuta in the United States.

Ryzneuta is developed for the treatment of Chemotherapy-Induced Neutropenia (CIN) in cancer patients after chemotherapy.

Aurobindo Pharma is the leading drug maker in India and it exports to over 155 countries across the globe with more than 90 percent of its revenues derived from international operations.

Shares of Aurobindo Pharma are trading 1.1 percent higher at Rs 442.10.