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 The leading web portal for pharmacy resources, news, education and careers March 21, 2019
Pharmacy Choice - Pharmaceutical News - Alembic Pharmaceuticals announces Orit Laboratories LLC receives USFDA Approval for Fenofibrate Tablets USP, 54 mg and 160 mg - March 21, 2019

Pharmacy News Article

 2/13/19 - Alembic Pharmaceuticals announces Orit Laboratories LLC receives USFDA Approval for Fenofibrate Tablets USP, 54 mg and 160 mg

Alembic Pharmaceuticals Limited (Alembic) today announced that its wholly owned step down subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Tablets USP, 54 mg and 160 mg.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc. (AbbVie). Fenofibrate Tablets USP, 54 mg and 160 mg are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia.

Fenofibrate Tablets USP, 54 mg and 160 mg have an estimated market size of US$ 92 million for twelve months ending December 2018 according to IQVIA.

Alembic has a cumulative total of 85 ANDA approvals (72 final approvals and 13 tentative approvals) from USFDA.

About Alembic Pharmaceuticals 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 pharmaceutical products 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.

Contact:

Ajay Kumar Desai

Tel: +91 22 306 11681

Email: ajay.desai@alembic.co.in



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