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Delafloxacin manufacturers

6 products found

Filters

6 products found
The only EU CTD dossier on the platform

delafloxacin

Solution for infusion 300 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
Available for various territories in EU (not EU5), CEE, Russia, CIS, APAC
Manufacturer #33499

The manufacturer is a global leader in pharmaceuticals and diagnostics, with a presence in over 140 countries across regions including Europe, Asia, Africa, and North America. With a history of over 135 years, the manufacturer specializes in prescription medications and diagnostics, focusing on key therapy areas such as oncology, cardiology, pneumology, and gastroenterology. It operates 18 manufacturing sites, including a biotech plant for monoclonal antibodies, and nine R&D centers dedicated to developing innovative therapies, including small molecules and biologics for hematologic and solid tumors. The manufacturer maintains GMP certifications and invests in advanced diagnostic technologies.

Manufacturer usually replies in 63 days

The only EU CTD dossier on the platform

delafloxacin

Tablets 450 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP
Comments
Available for various territories in EU (not EU5), CEE, Russia, CIS, APAC
Manufacturer #33499

The manufacturer is a global leader in pharmaceuticals and diagnostics, with a presence in over 140 countries across regions including Europe, Asia, Africa, and North America. With a history of over 135 years, the manufacturer specializes in prescription medications and diagnostics, focusing on key therapy areas such as oncology, cardiology, pneumology, and gastroenterology. It operates 18 manufacturing sites, including a biotech plant for monoclonal antibodies, and nine R&D centers dedicated to developing innovative therapies, including small molecules and biologics for hematologic and solid tumors. The manufacturer maintains GMP certifications and invests in advanced diagnostic technologies.

Manufacturer usually replies in 63 days

delafloxacin

Tablets 450 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
FDA
Registered in
United States
Manufacturer #38372

Manufacturer founded in 1993, with over 17,000 employees, acts as a CTD dossier owner and manufacturer. It is also a GMP manufacturer with approvals including NMPA (China), US FDA, EU GMP, UK MHRA. Products are sold in 70 countries and regions worldwide As a CTD dossier owner and manufacturer, it holds GMP manufacturer status for both APIs and finished dosage forms. There are 26 finished dosage production lines and 7 narcotic API production lines, certified under national top-ranking GMP standards. This Manufacturer is both CTD dossier owner and manufacturer in key therapeutic areas (steroid hormones, anesthetics etc.), combining R&D, registration and production. It functions as CTD dossier owner and manufacturer across multiple product types.

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