Alembic Pharmaceuticals gets USFDA final approval for ANDA Docetaxel Injection

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) SingleDose Vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Docetaxel Injection, 20 mg/2 mL, 80 mg/8 mL, and 160 mg/16 mL (10mg/mL), of Hospira, Inc. Docetaxcel Injections are indicated for the breast cancer, nonsmall cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck. Refer to our label for full indication.

Docetaxel Injection USP, 20 mg/2 mL (10 mg/mL) Single-Dose Vial, and 80 mg/8 mL (10 mg/mL) and 160 mg/16 mL (10 mg/mL) Multiple-Dose Vials, have an estimated market size of US$ 11 million for twelve months ending Dec 2022 according to IQVIA.

Alembic has a cumulative total of 181 ANDA approvals (158 final approvals and 23 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 510.05 as compared to the previous close of Rs. 509.60. The total number of shares traded during the day was 2382 in over 188 trades.

The stock hit an intraday high of Rs. 512.70 and intraday low of 506.30. The net turnover during the day was Rs. 1213476.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA DocetaxelInjection