Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per SingleDose Prefilled Syringe. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Faslodex Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP. Fulvestrant Injection is an estrogen receptor antagonist indicated for the treatment of breast cancer.
Fulvestrant Injection, 250 mg/5 mL, has an estimated market size of $71 million for twelve months ending September 2022 according to IQVIA. Alembic has received a cumulative total of 179 ANDA approvals (156 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 |
|---|---|
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| Dr. Reddys Lab | 1218.30 |
| Cipla | 1226.65 |
| Zydus Lifesciences | 936.00 |
| Lupin | 2339.20 |
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