Alembic Pharmaceuticals Limited (Alembic) today announced that it has received
final approval from the US Food & Drug Administration (USFDA ) for its Abbreviated
New Drug Application (ANDA) for Pirfenidone Tablets, 267 mg and 801 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product
(RLD) Esbriet Tablets, 267 mg and 801 mg, of Genentech, Inc. (Genentech).
Pirfenidone Tablets are indicated for the treatment of idiopathic pulmonary fibrosis
(IPF). Alembic had previously received tentative approval for this ANDA. Alembic
was one of the first ANDA applicants to submit a substantially complete ANDA with a
paragraph IV certification. It may not be indicated for certain other uses due to
unexpired exclusivities for the RLD for such uses.
Pirfenidone Tablets, 267 mg and 801 mg have an estimated market size of US$ 548
million for twelve months ending December 2021 according to IQVIA. Alembic hassettled the case with Genetech and will launch its generic as per the terms of settlement.
Alembic has a cumulative total of 167 ANDA approvals (144 final approvals and 23 tentative approvals) from USFDA. 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.
Information about Alembic can be found
at https://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg:
forALPM) (NSE: APLLTD) (BSE: 533573)
