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Alembic Pharmaceuticals rises on getting USFDA’s final approval for Macitentan Tablets

Macitentan Tablets, 10 mg, have an estimated market size of $1,180 million for twelve months ending June 2025 according to IQVIA

Alembic Pharmaceuticals is currently trading at Rs. 980.55, up by 7.25 points or 0.74% from its previous closing of Rs. 973.30 on the BSE.

The scrip opened at Rs. 968.40 and has touched a high and low of Rs. 998.65 and Rs. 968.40 respectively. So far 3799 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1296.15 on 09-Oct-2024 and a 52 week low of Rs. 725.60 on 03-Mar-2025.

Last one week high and low of the scrip stood at Rs. 998.65 and Rs. 940.10 respectively. The current market cap of the company is Rs. 19193.41 crore.

The promoters holding in the company stood at 69.67%, while Institutions and Non-Institutions held 20.42% and 9.90% respectively.

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Macitentan Tablets, 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Opsumit Tablets, 10 mg, of Actelion Pharmaceuticals US, Inc. (Actelion).

Macitentan tablets are an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. 

Macitentan Tablets, 10 mg, have an estimated market size of $1,180 million for twelve months ending June 2025 according to IQVIA. The company has a cumulative total of 224 ANDA approvals (203 final approvals and 21 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.