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4 products found

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4 products found

eliglustat

Capsules 84 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP, FDA
Manufacturer #17457
In the past fifty years, the company has reached significant milestones—a result of enviable performance, strict adherence to the highest ethical and operational standards, and full compliance with global regulatory authorities. During this journey, they have emerged as one of the leading in-house development partners based in Europe, specializing in the development, registration, manufacturing, and life-cycle management of highly complex pharmaceutical technologies and generic formulations.

Manufacturer usually replies in 31 days

eliglustat

Capsules 84 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

eliglustat

Capsules 84 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Comments
Ref. product: Cerdelga® Sanofi-Aventis
Manufacturer #261
A pharmaceutical manufacturer based in the EU that has been selling its products in Europe for 20+ years. Main therapeutic areas include diabetes, CNL, dermatology, and oncology. Main dosage forms include solid and liquid oral, sterile dosage forms, and ointments. The company possesses 10+ manufacturing facilities that are cGMP-compliant.

Manufacturer usually replies in 16 days

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