Granules India gets USFDA nod for Trospium Chloride ER Capsules
Hyderabad: Granules India Limited has announced that 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 Limited 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.
"We are pleased to announce the 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., commenting on the approval.
Trospium Chloride Extended-Release Capsules, 60 mg 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 have a total of 26 ANDA approvals from US FDA (24 Final approvals and 2 tentative approvals).
Granules India is an Indian pharmaceutical manufacturing company which was founded in 1984 named Triton Laboratories located in Hyderabad, India.
Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets.
Granules India Limited entered the CRAMS segment, which focuses on contract research and manufacturing. Granules has seven manufacturing facilities; six are in India while the seventh is through a joint venture with the Hubei Bio case in Wuhan, China along with two research centers, at Hyderabad and Pune.