Granules now has a total of 26 ANDA approvals from US FDA (24 Final approvals and 2 tentative approvals).
Granules India share price rose 6 percent in the early trade on April 24 after company had received USFDA approval dor drug for the treatment of overactive bladder.
The US Food & Drug Administration (US FDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India for Trospium Chloride Extended-Release Capsules, 60 mg, as per company release.
It is bioequivalent to the reference listed drug product (RLD), Sanctura XR Capsules, 60 mg, of Allergan, Inc.
Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
“We are pleased to announce approval of this niche, limited competition product, which is a nice addition to our growing product portfolio in the US market,” said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc.
Trospium had US sales of approximately USD 25 million MAT for the most recent 12 months ending in February 2020, according to IQVIA Health.
Granules now has a total of 26 ANDA approvals from US FDA (24 Final approvals and 2 tentative approvals).At 09:52 hrs, Granules India was quoting at Rs 165.90, up Rs 5.40, or 3.36 percent on the BSE.