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Fesoterodine fumarate manufacturers

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fesoterodine fumarate

Tablets, prolonged release (PR) 4 mg, 8 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #419

The manufacturer based in Europe, has decades of experience in the industry. They focus on a diverse range of products, including prescription drugs, over-the-counter medications, and medical devices. Their portfolio covers a variety of therapeutic areas, with key focuses on cardiovascular health, oncology, and pain management. The manufacturer holds numerous patents for their innovative products and adheres to strict GMP standards for both the European Union and the United States. They distribute their products across key regions in Europe, North America, and other international markets. Their production lines include solid oral dosage forms, injectables, and liquids, offering a wide range of treatment options for patients.

fesoterodine fumarate

Tablets, extended release (ER) 4 mg, 8 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Manufacturer #23786
Founded in the 1950s with nearly seven decades of pharmaceutical leadership, this integrated pharma company is among the top players in its home market. Rx and OTC portfolio spans branded generics, biosimilars, APIs, and novel drugs across oncology, metabolic, cardiac, and infectious disease therapy areas. US FDA and EU-GMP approved facilities operate across multiple continents.

fesoterodine fumarate

Tablets, extended release (ER) 4 mg, 8 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO, EU GMP
Manufacturer #20273
A pharmaceutical manufacturer specializing in contract research and development as well as formulation services for pharmaceutical products including solid orals, injectables, liquids, ophthalmics and complex/niche dosage forms. The company offers comprehensive services spanning pre-formulation, formulation development, analytical method development and validation, stability testing, bioequivalence support, dossier preparation, and regulatory-filing assistance — enabling partners to take products from development through to commercialization under globally accepted standards. Their facilities are described as compliant with USFDA/EU-approved manufacturing requirements, supporting development of both generic and specialized pharmaceutical products for global markets.

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