ALEMBIC PHARMACEUTICALS LIMITED PRESS RELEASE
22nd June,2017,Vadodara ,India
Alembic Pharmaceuti cals receives USFDA Approval for Amantadi ne Hydrochloride Capsules1USP
Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Amantadine Hydrochloride Capsules,USP,1OOmg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Symmetrel® Capsules, 100mg ,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.
Amantadine Hydrochloride Capsules have an estimated market size of US$ 37 million for twelve months ending December 2016 according to IMS.
Alembic now has a total of 58 ANDA approvals (52 final approvals and 6 tentative approvals) from USFDA.
About Alembic PharmaceuticalsLimited
Alembic Pharmaceuticals Limited,a vertically integrated research and development pharmaceutical company ,has been at the forefront of healthcare since 1907. Headquartered inIndia,Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of theart research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands,marketed through a marketing team of over 5000 are well recognized by doctors and patients.
Information about the company can be found at http://www.alembicpharmaceuti cals.com/; (Reuters: ALEM .NS) (Bloomberg: ALPM) (NSE: APLLTD) (SSE:533573)
For more information contact:
Ajay Kumar Desai Mitanshu Shah
Phone: +91 22 -306 11681 Phone: +91 265 -3007630
Email:ajay.desai@alembic.co.inEmail:mitanshu.shah@al embic.co.i n
ALEMBIC PHARMACEUTICALS LIMITED
REG.OFFICE :ALEBIC ROAD,VADODARA - 390003.•TEL :(0265) 2280550, 2280880• FAX :(0265) 2281229
website :www.alemb1cpharmaceuticals.com • E-mail :alembic@alembic.co.in•CIN :l24230GJ2010PLC061123
Alembic Pharmaceuticals Limited published this content on 22 June 2017 and is solely responsible for the information contained herein.
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