Granules has a total of 27 ANDA approvals from US FDA (25 Final approvals and 2 tentative approvals).
US Food & Drug Administration (USFDA) has approved JB Chemicals' abbreviated new drug application (ANDA) for Carbamazepine Extended-Release Tablets USP 100 mg, 200 mg and 400 mg. (for treatment of Epilepsy and Trigeminal Neuralgia).
The product is a generic version of Tegretol XR tablet in the same strength of Novartis Pharmaceuticals Corp.
The Company plans to commercialise this product in Q3 of this financial year and is expected to boost the Company's US sales.
USFDA has also approved the ANDA filed by Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of Granules India for Vigabatrin for Oral Solution USP, 500 mg.
It is bioequivalent to the reference listed drug product (RLD), Sabril (vigabatrin) for Oral Solution, 500 mg, of Lundbeck Pharmaceuticals LLC.
Granules now has a total of 27 ANDA approvals from US FDA (25 Final approvals and 2 tentative approvals).At 09:30 hrs, Granules India was quoting at Rs 173.75, up Rs 6.45, or 3.86 percent and JB Chemicals was quoting at Rs 559, up Rs 6.35, or 1.15 percent on the BSE.