Alembic Pharma gets USFDA approval for Amantadine Hydrochloride tablets

Indian multinational pharmaceutical company, Alembic Pharmaceuticals Limited announced on Friday that it has received USFDA approval for Amantadine Hydrochloride tablets, 100 mg. 

The pharma company got approval from United States Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) Amantadine Hydrochloride tablets, 100 mg. The drug is therapeutically equivalent to the reference listed drug product (RLD), Symmetrel tablets, 100 mg, of Endo Pharmaceuticals, Inc. (Endo).

The drug is indicated for the prophylaxis of signs and symptoms of infection caused by various strains of influenza A virus and is also used in the treatment of parkinsonism and drug-induced extrapyramidal reactions.

Alembic Pharmaceuticals is vertically integrated with the ability to develop, manufacture & market pharmaceutical products, pharmaceutical substances, and intermediates. Formulations make up 85 per cent of the revenue and API makes up for the remaining 15 per cent.

At 1.40 pm, its share was trading at Rs 945.35, lower by 0.35 per cent than Thursday’s closing price. The share has an intraday high of Rs 957 and an intraday low of Rs 933 on BSE.