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Clascoterone manufacturers

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clascoterone

Cream 1 %

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP, China
Comments
Ref : Winlevi®
Manufacturer #252

This company is a leading player in the pharmaceutical industry, boasting decades of experience in research, development, and manufacturing. They specialize in the production of a wide range of pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) for both human and veterinary use. Their product portfolio spans multiple therapeutic areas, including but not limited to, oncology, cardiology, and other essential therapeutic categories. They offer a comprehensive range of services, including contract manufacturing (CMO) and the production of over-the-counter (OTC) products. The company holds EU and US GMP approvals for its production lines, ensuring adherence to rigorous quality standards. Their production lines encompass various dosage forms, including solids, liquids, and injectables. Their global presence extends across Europe and North America, with a network of 10 manufacturing facilities. They have a strong commitment to research and development, with dedicated teams focusing on innovative solutions and advancements in the pharmaceutical field.

Manufacturer usually replies in 37 days

clascoterone

Cream 1 %

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Bangladesh
GMP approvals
Bangladesh
Manufacturer #36531

Established in 1963, this manufacturer specializes in producing hormones, steroids, and other pharmaceutical products in various dosage forms, including tablets, capsules, injections, and ophthalmic drops. As a CTD dossier owner and manufacturer, it holds GMP approvals from multiple international regulatory authorities, including the U.S. FDA, the Therapeutic Goods Administration (TGA) of Australia, and the Malta Medicines Authority (European Union). The manufacturer operates advanced production lines adhering to stringent GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed in multiple countries worldwide.

 

 

 

 

Manufacturer usually replies in 19 days

clascoterone

Cream 1 %

Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
China
Manufacturer #18656
This China-based firm provides comprehensive regulatory and market-entry services for pharmaceutical products, offering support that spans API and finished-dosage registration, DMF and CTD preparation, clinical and marketing-authorization submissions, and the sourcing and registration of APIs, reference substances, impurities, excipients, and intermediates, while also delivering translation, dossier development, and quality-review services that assist any pharmaceutical manufacturer seeking compliance within the Chinese market.

Manufacturer usually replies in 42 days

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