Alembic Pharmaceuticals receives USFDA Final Approval for Pirfenidone Tablets, 267 mg and 801 mg

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 has settled 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.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 760.40 as compared to the previous close of Rs. 752.85. The total number of shares traded during the day was 3252 in over 407 trades.

The stock hit an intraday high of Rs. 774.85 and intraday low of 744.25. The net turnover during the day was Rs. 2487896.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 ANDA USFDA FinalApproval PirfenidoneTablets