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gadoterate meglumine

Solution for injection 27.7 % - 10 ml, 15 ml, 20 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP, Greece
Unavailable markets
Austria , Belgium , Bulgaria , Croatia , Cyprus , Czech Republic , Denmark , Estonia , Finland , France , Germany , Greece , Hungary , Iceland , Ireland , Italy , Kosovo , Latvia , Lithuania , Malta , Netherlands , Norway , Poland , Portugal , Romania , Slovakia , Spain , Sweden , United Kingdom , Vietnam
Available for
Distribution only
Comments
Product is not available for Europe
Manufacturer #298

This company is a global pharmaceutical and commercial organization that has been operating for over five decades. It specializes in injectable and prescription drug products, medical devices, and food supplements. Their manufacturing facilities are EU and US GMP approved. They have a strong presence in international markets, especially in Europe, North America, and Asia. The company also prides itself on its commitment to research and development of new products, particularly in the field of monoclonal antibodies. This commitment has earned them recognition and awards for their innovation and manufacturing excellence.

Manufacturer usually replies in 8 days

gadoterate meglumine

Vials, injection 0.5 mmol/ml - 5 ml, 10 ml, 15 ml, 20 ml, 50 ml, 60 ml, 100 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
EU GMP
Manufacturer #2722
It originally entered the pharmaceutical industry in 1987, when it introduced blood derivative products to Europe and became the exclusive distributor for prominent European brands. Oncology, hematology, dermatology, radiology, rheumatology, immunology, and OTC products are the seven main therapeutic fields.

Manufacturer usually replies in 7 days

gadoterate meglumine

Injection 376.9 mg/ml

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

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