Alembic Pharmaceuticals gets USFDA nod for Parkinson’s drug

Pharmaceutical manufacturer Alembic Pharmaceuticals Ltd said it received approval from the United States Food and Drug Administration (USFDA) for the sales of a therapeutic equivalent of Merck Sharp & Dohme Corp’s Sinemet Carbidopa/Levodopa sustained release tablets in the US market.

Carbidopa and Levodopa Extended-Release tablets are used to treat symptoms of Parkinson’s disease and Parkinson’s-like symptoms that may develop after encephalitis, i.e. the swelling of the brain or injury to the nervous system caused by carbon monoxide poisoning or manganese poisoning.

Carbidopa and Levodopa Extended-Release tablets, in doses of 25 mg, 50 mg, 100 mg and 200 mg, had annual sales of USD 24 million for twelve months ending December 2018.

With the latest nod, Alembic has so far received 95 approvals, including 83 final and 12 tentative approvals from the USFDA.

Headquartered in Vadodara, Alembic manufactures and markets generic pharmaceutical products all over the world.

Established in 1907, it is also one of the leaders in branded generics in India, and has a marketing team of over 5,000 in its home market.