- Home
- Medical news & Guidelines
- Anesthesiology
- Cardiology and CTVS
- Critical Care
- Dentistry
- Dermatology
- Diabetes and Endocrinology
- ENT
- Gastroenterology
- Medicine
- Nephrology
- Neurology
- Obstretics-Gynaecology
- Oncology
- Ophthalmology
- Orthopaedics
- Pediatrics-Neonatology
- Psychiatry
- Pulmonology
- Radiology
- Surgery
- Urology
- Laboratory Medicine
- Diet
- Nursing
- Paramedical
- Physiotherapy
- Health news
- AYUSH
- State News
- Andaman and Nicobar Islands
- Andhra Pradesh
- Arunachal Pradesh
- Assam
- Bihar
- Chandigarh
- Chattisgarh
- Dadra and Nagar Haveli
- Daman and Diu
- Delhi
- Goa
- Gujarat
- Haryana
- Himachal Pradesh
- Jammu & Kashmir
- Jharkhand
- Karnataka
- Kerala
- Ladakh
- Lakshadweep
- Madhya Pradesh
- Maharashtra
- Manipur
- Meghalaya
- Mizoram
- Nagaland
- Odisha
- Puducherry
- Punjab
- Rajasthan
- Sikkim
- Tamil Nadu
- Telangana
- Tripura
- Uttar Pradesh
- Uttrakhand
- West Bengal
- Medical Education
- Industry
Granules India gets USFDA nod for Trospium Chloride ER Capsules
![Granules India gets USFDA nod for Trospium Chloride ER Capsules Granules India gets USFDA nod for Trospium Chloride ER Capsules](https://medicaldialogues.in/h-upload/2020/04/25/750x450_127806-125287-granules-pharma.webp)
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.
Read also: Granules India Gets USFDA Approval For Butalbital, Acetaminophen, Caffeine Capsules
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751