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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.

Manufacturer usually replies in 14 days

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.

Manufacturer usually replies in 14 days

fesoterodine fumarate

Tablets, film coated 4 mg, 8 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP, ANVISA, TGA, Mexico, South Africa
Manufacturer #9258

This company is a research-driven pharmaceutical manufacturer specializing in oral solid dosage forms. They offer both pharmaceutical and nutraceutical products, including pre-formulation intermediates like granules and pellets, as well as finished formulations such as tablets, capsules, and oral thin films. Their focus is on developing differentiated generic products using innovative process technologies to enhance patient convenience and affordability. Key therapy areas include urology, cardiovascular health, infectious diseases, gastrointestinal disorders, pain management, vitamins, and skin conditions. The company holds EU-GMP certifications alongside WHO-GMP, ISO 9001, and NSF/ANSI 455-2 certifications. They operate with a robust R&D center recognized by the Indian government and collaborate with pharmaceutical companies globally for product development and marketing.

Manufacturer usually replies in 34 days

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