Alembic Pharmaceuticals jumps on getting USFDA`s tentative nod for Darolutamide Tablets
Alembic Pharmaceuticals is currently trading at Rs. 781.55, up by 13.15 points or 1.71% from its previous closing of Rs. 768.40 on the BSE.
The scrip opened at Rs. 765.00 and has touched a high and low of Rs. 791.05 and Rs. 765.00 respectively. So far 7503 shares were traded on the counter.
The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 1107.80 on 30-Jun-2025 and a 52 week low of Rs. 635.30 on 23-Mar-2026.
Last one week high and low of the scrip stood at Rs. 836.00 and Rs. 720.00 respectively. The current market cap of the company is Rs. 15270.01 crore.
The promoters holding in the company stood at 69.74%, while Institutions and Non-Institutions held 20.43% and 9.83% respectively.
Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Darolutamide Tablets, 300 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nubeqa Tablets, 300 mg, of Bayer HealthCare Pharmaceuticals Inc. (Bayer).
Darolutamide is an androgen receptor inhibitor indicated for the treatment of adult patients with: i) non-metastatic castration-resistant prostate cancer (nmCRPC), ii) metastatic castration-sensitive prostate cancer (mCSPC), and iii) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
Darolutamide Tablets, 300 mg, have an estimated market size of $3,155 million for twelve months ending March 2026 according to IQVIA. The company has a cumulative total of 238 ANDA approvals (219 final approvals and 19 tentative approvals) from USFDA.
