Granules India announced today morning that it has received the US FDA approval for the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., its wholly owned foreign subsidiary, for Trospium Chloride Extended-Release Capsules, 60 mg.
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.
These capsules had U.S. sales of approximately $25 million MAT for the most recent twelve 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).
The stock price has reacted positively to this news; the price rose 6% to hit an intraday high at Rs.169.80 and currently trades at Rs.165 levels.