Granules India has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets USP, 50 mg, 100 mg, 150 mg, and 300 mg. It is bioequivalent and therapeutically equivalent to the reference listed drug, Desyrel Tablets, 50 mg, 100 mg, 150 mg, and 300 mg, of Pragma Pharmaceuticals, LLC.
Trazodone tablets are indicated for the treatment of major depressive disorder in adults. Granules now has 65 ANDA approvals from the USFDA (64 final approvals and 1 tentative approval). The current annual U.S. market for Trazodone tablets is approximately $128 million, according to MAT Jun 2024, IQVIA/IMS Health.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1665.25 |
| Dr. Reddys Lab | 1220.75 |
| Cipla | 1232.90 |
| Zydus Lifesciences | 928.85 |
| Lupin | 2311.75 |
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