Gadoteridol manufacturers

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gadoteridol

Injection 279.3 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.

gadoteridol

Solution for injection 279.3 mg/ml

Dossier type
US CTD
Dossier status
Under development
Country of origin
China
GMP approvals
FDA
Manufacturer #16160

The company is a leading integrated pharmaceutical group specializing in traditional Asian medicine, chemical medicine, and biopharmaceutical products. It operates multiple subsidiaries and is recognized as a top innovator with state-of-the-art research facilities, including national engineering and technology centers. The company collaborates with over 100 research institutions globally and has received prestigious national awards for technological innovation and scientific progress. It maintains high standards of quality with certifications from ICH, FDA, and EDQM, and has passed national GMP authentication. The company focuses on innovation and service, aiming to strengthen its position in chemical pharmaceuticals, traditional Asian medicine, and biopharmaceuticals.

gadoteridol

Solution for injection 279.3 mg/ml - 5 ml, 10 ml, 15 ml, 20 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
FDA
Manufacturer #8101

A pharmaceutical manufacturer offering both active pharmaceutical ingredients (APIs) and finished dosage pharmaceutical products, with multiple production bases and full-chain capabilities from raw materials to formulations. The company has passed cGMP certifications in China, Europe and the U.S., with manufacturing lines for injectables, oral solids and other complex dosage forms, and supports global exports with extensive R&D and CDMO/CMO services.

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