Alembic Pharmaceuticals gains on getting USFDA’s tentative approval for Macitentan Tablets
Alembic Pharmaceuticals is currently trading at Rs. 729.90, up by 0.85 points or 0.12% from its previous closing of Rs. 729.05 on the BSE.
The scrip opened at Rs. 730.45 and has touched a high and low of Rs. 737.75 and Rs. 725.00 respectively. So far 5095 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1090.00 on 27-Apr-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. 741.80 and Rs. 711.85 respectively. The current market cap of the company is Rs. 14407.09 crore.
The promoters holding in the company stood at 69.48%, while Institutions and Non-Institutions held 17.50% and 13.03% respectively.
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Macitentan Tablets, 10 mg. The tentatively 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) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Macitentan Tablets also reduced hospitalization for PAH. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses. Macitentan Tablets, 10 mg have an estimated market size of $ 797 million for twelve months ending Dec 2021 according to IQVIA.
Alembic has received year to date (YTD) 22 approvals (15 final approvals and 7 tentative approvals) and a cumulative total of 161 ANDA approvals (138 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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