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

Today, the stock opened at Rs 509.35 and has touched a high and low of Rs 525.95 and Rs 507.70 respectively.

At 12 pm, the shares of Alembic Pharmaceuticals were trading at Rs 525, up by 23.45 points or 4.68% from its previous closing of Rs 501.55 on the BSE.

Receiving final approval from USFDA

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.

Stock price movement

The BSE group 'A' stock of face value of Rs 2 has touched a 52-week high and low of Rs 792.30 and Rs 476.30, respectively. 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 10,238.97 crore.

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

Company Profile

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company is in the business of development, manufacturing, and marketing of Pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients. The company has 3 R&D and 5 manufacturing facilities.