Alembic Pharmaceuticals trades higher on getting final nod from USFDA for Pirfenidone Tablets
Alembic Pharmaceuticals is currently trading at Rs. 767.75, up by 7.35 points or 0.97% from its previous closing of Rs. 760.40 on the BSE.
The scrip opened at Rs. 760.70 and has touched a high and low of Rs. 768.50 and Rs. 754.00 respectively. So far 1638 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1025.00 on 11-Jun-2021 and a 52 week low of Rs. 672.00 on 22-Feb-2022.
Last one week high and low of the scrip stood at Rs. 774.85 and Rs. 730.55 respectively. The current market cap of the company is Rs. 14838.55 crore.
The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.76% and 12.63% respectively.
Alembic Pharmaceuticals 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 $ 548 million for twelve months ending December 2021. Alembic has settled the case with Genetech and will launch its generic as per the terms of settlement. The company has a cumulative total of 167 ANDA approvals (144 final approvals and 23 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
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