Alembic Pharmaceuticals spurts on getting USFDA’s final approval for Fluorouracil Injection

Alembic Pharmaceuticals Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 533573 | NSE: APLLTD

06 Mar 2023 Evaluate

Alembic Pharmaceuticals is currently trading at Rs. 516.90, up by 15.35 points or 3.06% from its previous closing of Rs. 501.55 on the BSE.

The scrip opened at Rs. 509.35 and has touched a high and low of Rs. 516.90 and Rs. 507.70 respectively. So far 1760 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 2 has touched a 52 week high of Rs. 792.30 on 28-Apr-2022 and a 52 week low of Rs. 476.30 on 03-Mar-2023.

Last one week high and low of the scrip stood at Rs. 529.10 and Rs. 476.30 respectively. The current market cap of the company is Rs. 9987.37 crore.

The promoters holding in the company stood at 69.61%, while Institutions and Non-Institutions held 17.75% and 12.64% respectively.

Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc. (Spectrum).

Fluorouracil Injection is indicated for the treatment of patients with adenocarcinoma of colon and rectum, adenocarcinoma of the breast, gastric adenocarcinoma and pancreatic adenocarcinoma.

Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Vial, has an estimated market size of $5 million for twelve months ending December 2022 according to IQVIA. Alembic has a cumulative total of 182 ANDA approvals (159 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.

Alembic Pharma Share Price

785.40 8.05 (1.04%)

08-May-2026 16:59 View Price Chart

Peers

Company Name	CMP
Sun Pharma Inds.	1847.30
Dr. Reddys Lab	1293.25
Cipla	1347.70
Zydus Lifesciences	938.90
Lupin	2377.90
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