Alembic Pharmaceuticals gets USFDA Final Approval for Fluorouracil Injection USP

Alembic Pharmaceuticals Limited (Alembic) today announced it 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. Refer to our label for full indication.

Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Vial, has an estimated market size of US$ 5 million for twelve months ending Dec 2022 according to IQVIA.

Alembic has a cumulative total of 182 ANDA approvals (159 final approvals and 23 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 501.55 as compared to the previous close of Rs. 503.20. The total number of shares traded during the day was 15577 in over 1181 trades.

The stock hit an intraday high of Rs. 509.75 and intraday low of 476.30. The net turnover during the day was Rs. 7729534.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA ANDA FinalApproval FluorouracilInjection