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edoxaban tosylate

Tablets, film coated 15mg, 30mg, 60mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Available for
Licensing with supply
Comments
Interested in projects only for European markets.
Manufacturer #15224
This pharmaceutical company is a leader in its region, recognized for producing high-quality, affordable medications. With over four decades of experience, it operates two state-of-the-art manufacturing facilities certified by both EU and WHO-cGMP standards. Their R&D center, recognized by the Indian government, focuses on developing novel drug delivery systems to improve patient compliance. The company's product portfolio spans a wide range of therapy areas, including cardiovascular, anti-diabetic, lipid-lowering, pain management, respiratory system, vitamins & nutrition, and gastrointestinal health. They offer various dosage forms, such as tablets, capsules, and syrups.

Manufacturer usually replies in 15 days

edoxaban tosylate

Tablets 15 mg, 30 mg, 6- mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #34252

Established in 2004, this vertically integrated pharmaceutical manufacturer is committed to delivering high-quality, affordable medicines globally. As a CTD dossier owner and manufacturer, it holds GMP certifications from the US FDA, EU, and WHO, ensuring compliance with stringent international quality standards. The company's state-of-the-art R&D center is capable of handling oral solids, liquids, and parenteral formulations. Its products have received marketing authorizations from regulatory authorities such as the US FDA, Health Canada, CDSCO-India, and New Zealand. With over 20 ANDA/ANDs under approval, the manufacturer operates advanced production lines adhering to rigorous GMP guidelines. Its diverse portfolio includes therapeutics in areas like antivirals, neurology, women's health, cardiology, and imaging contrast agents.

Manufacturer usually replies in 8 days

edoxaban tosylate

Tablets 15 mg, 30 mg, 60 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
India
Manufacturer #16857
A pharmaceutical manufacturer with integrated capabilities in active pharmaceutical ingredients, intermediates, and finished formulations, supplying pharmaceutical products to global partners across key therapy areas such as diabetes, cardiac care, neurology, anti-bacterial and anti-fungal segments. The organisation highlights strong in-house R&D, backward integration into intermediates and APIs, and scalable manufacturing from development to multi-ton commercial output. For quality, the site states that its formulation manufacturing operates in a GMP-compliant facility recognised by major regulators, and specifically lists approvals/recognition including USFDA, EU-GMP, WHO and TGA, supporting reliable international supply of pharmaceutical products.

Manufacturer usually replies in 10 days

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