Pharma major Alembic Pharmaceuticals Ltdon Thursday announced that it has received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride Capsules, USP, 100 mg.
According to the company, the approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Symmetrel Capsules, 100 mg, of Endo Pharmaceuticals Inc.
“Amantadine Hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions,” it said.
Amantadine Hydrochloride Capsules have an estimated market size of $37 million for 12 months ending December 2016 according to IMS.
Based in Gujarat, Alembic Pharmaceuticals develops, manufactures and markets pharmaceutical products, pharmaceutical substances and intermediates. The company is in the Macrolides segment of anti-infective drugs in India. Alembic’s manufacturing facilities are located in Vadodara and Baddi in Himachal Pradesh.
Alembic now has a total of 58 ANDA approvals (52 final approvals and 6 tentative approvals) from the USFDA.
Alembic shares were trading in red at Rs 527, down 0.92% from the previous closing of Rs 531.90, on BSE at 1.01pm today.

here is company details.

 

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