PRESS RELEASE
15th May,2017, Vadodara, India
Alembi cPharmaceuticalsreceivesUSFDAA pproval for Fenofibric Aci dDel ayedReleaseCapsul es
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 Fenofibric Acid Delayed-Release Capsules, 45 mg and 135 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trilipix® Delayed-Release Capsules, 45 mg and 135 mg,of Abbvie Inc. Fenofibric Acid DelayedRelease Capsules are indicated as an adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia and to reduce elevated LDL-C,total cholesterol (Total-C), TG and Apo B,and to increase HDL-C in patients with primary hypercholesterolemia or mixed dyslipidemia.
Fenofibric Acid Delayed-Release Capsules have an estimated market size of US$ 93 million for twelve months ending December 2016 according to IMS.
Alembic now has a total of 56 ANDA approvals (50 final approvals and 6 tentative approvals) from USFDA.
AboutAlembi cPharmaceuticals Limited
Alembic Pharmaceuticals Limited,a vertically integrated research and development pharmaceutical company,has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceuticalproducts all over the world.Alembic's state of the art 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.alembicpharmaceuticals.com; (Reuters: ALEM.NS) (Bloomberg:ALPM) (NSE: APLLTD) (BSE:533573)
For more information contact:
Ajay Kumar Desai Mitanshu Shah
Phone: +91 22 - 306 11681 Phone:+91 265 - 3007630
Email:ajay.desai@alembic.co.in Email:mitanshu .shah@alembic.co.in
ALEMBIC PHARMACEUTICALS LIMITED
REGO. OFFICE :ALEMBIC ROAD,VADODARA •390 003.INDIA •TEL :+91-0265-2280550 •FAX :+91-0265-2282837
Website :www.alembic india.com •E-mail:alembic@alembic.co.in
CIN:L24230GJ2010PLC061123
Alembic Pharmaceuticals Limited published this content on 15 May 2017 and is solely responsible for the information contained herein.
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