US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules India for Fexofenadine Hydrochloride Tablets USP, 60 mg and 180 mg (OTC). It is bioequivalent to the reference listed drug product (RLD), Allegra Allergy Tablets, 60 mg and 180 mg, of Sanofi-Aventis US LLC.
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. | 1673.45 |
| Dr. Reddys Lab | 1235.10 |
| Cipla | 1233.00 |
| Zydus Lifesciences | 939.95 |
| Lupin | 2330.65 |
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