Alembic Pharmaceuticals (Alembic) 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) Single-Dose 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 (10 mg/mL), of Hospira, Inc. Docetaxcel Injections are indicated for the breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, gastric adenocarcinoma and squamous cell carcinoma of head and neck.
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 $11 million for twelve months ending December 2022 according to IQVIA. Alembic has a cumulative total of 181 ANDA approvals (158 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.
| Company Name | CMP |
|---|---|
| Sun Pharma. Inds. | 1876.40 |
| Dr. Reddys Labs. | 1180.50 |
| Cipla | 1431.85 |
| Lupin | 2225.00 |
| Zydus Lifesciences | 1117.00 |
| View more.. | |
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