Maithri Drugs Private Limited, a leading Indian pharmaceutical API manufacturer, has announced the successful filing of its 71st US Drug Master File (USDMF #041847) for Trospium Chloride, a key active pharmaceutical ingredient (API) used in the treatment of Overactive Bladder (OAB) and other conditions.
This milestone highlights Maithri’s continued growth in the regulated markets and its commitment to delivering high-quality, affordable APIs for global healthcare.
About Trospium Chloride
Trospium Chloride is an anticholinergic medication approved for managing Overactive Bladder (OAB) symptoms such as:
- Urinary urgency
- Frequent urination
- Urge urinary incontinence
It works by blocking acetylcholine receptors in the bladder, thereby reducing involuntary contractions and improving bladder control.
Dosage Forms and Therapeutic Use
Trospium Chloride is available in two main dosage forms:
- Immediate-Release Tablets (20 mg): Typically taken twice daily
- Extended-Release Capsules (60 mg): Taken once daily
The drug is approved both as a standalone therapy and as a combination therapy:
- Standalone: For treating OAB symptoms in adults
- Combination: Paired with xanomeline under the brand name Cobenfy, approved for treating schizophrenia in adults
Safety Profile and Precautions
While effective, Trospium Chloride should be used cautiously. It is contraindicated in patients with:
- Glaucoma
- Urinary retention
- Severe gastrointestinal motility disorders
Common side effects include dry mouth, constipation, and blurred vision.
Strategic Importance
Maithri’s 71st USDMF filing underscores its growing influence in the urology and central nervous system (CNS) API markets. The company continues to strengthen its position in regulated markets like the United States by maintaining a robust pipeline of high-quality APIs.
Speaking on the achievement, a senior official from Maithri Drugs stated, “This milestone reflects our commitment to innovation, compliance, and meeting the dynamic needs of the global pharmaceutical industry.”
