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teneligliptin hydrobromide + metformin hydrochloride

Tablets 10 mg + 500 mg, 10 mg + 750 mg, 20 mg + 1000 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
EU GMP, WHO, PICS
Manufacturer #20943

​Established in 1954, this Manufacturer is a CTD dossier owner and manufacturer with a global presence spanning over 15 countries and regions. With a workforce of approximately 1,000 employees, it operates GMP-certified facilities in South Korea, producing tablets, capsules, and injectable formulations. As a GMP manufacturer, it holds certifications such as PIC/S GMP and EU GMP compliance. The Manufacturer's commitment to excellence as a CTD dossier owner and manufacturer and GMP manufacturer solidifies its reputation in the global pharmaceutical market.​

 

Manufacturer usually replies in 11 days

teneligliptin hydrobromide

Tablets 20 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
EU GMP, WHO, PICS
Manufacturer #20943

​Established in 1954, this Manufacturer is a CTD dossier owner and manufacturer with a global presence spanning over 15 countries and regions. With a workforce of approximately 1,000 employees, it operates GMP-certified facilities in South Korea, producing tablets, capsules, and injectable formulations. As a GMP manufacturer, it holds certifications such as PIC/S GMP and EU GMP compliance. The Manufacturer's commitment to excellence as a CTD dossier owner and manufacturer and GMP manufacturer solidifies its reputation in the global pharmaceutical market.​

 

Manufacturer usually replies in 11 days

teneligliptin hydrobromide + metformin hydrochloride

Tablets, sustained release (SR) 10 mg + 500 mg, 10 mg + 750 mg, 20 mg + 1000 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
South Korea
GMP approvals
PICS
Manufacturer #35087

Established in 2020, this manufacturer employs approximately 677 individuals and specializes in providing comprehensive pharmaceutical manufacturing services, including product development, analytical and regulatory services, as well as clinical and commercial manufacturing and packaging for various dosage forms. As a CTD dossier owner and manufacturer, it holds GMP certifications from international regulatory authorities, ensuring compliance with stringent quality standards. The manufacturer operates advanced production lines adhering to rigorous GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed in over 20 countries worldwide.

Manufacturer usually replies in 14 days

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