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zoledronic acid monohydrate

Concentrate for solution for injection 4 mg/5 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
FDA, EU GMP
Manufacturer #13072
This pharmaceutical company, established in 1958, boasts a long history and operates across multiple regions, including Europe and North America. They specialize in the production of prescription medications, with a focus on three key therapy areas: oncology, immunology, and dermatology. Their principal dosage forms include tablets, capsules, and topical solutions. The company possesses GMP certifications and holds patents for several product innovations. With three production facilities and a logistics center, they prioritize efficiency and international expansion, aiming to become a global leader in the pharmaceutical industry.

Manufacturer usually replies in 15 days

zoledronic acid monohydrate

Injection 5 mg/100 ml - 100 ml

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

zoledronic acid monohydrate

Vials, injection 4 mg/5 ml - 5 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
PICS
Manufacturer #2272
The company integrates and applies enormous experience and technology in the field of hospital products. Their goal is to become a global leader in intensive care units and maintain that position. The company's headquarters were established in Europe in 1980ies, and serum production was continuing in a plant in Europe till the end of the 2000s. With a nationwide market share of 50%, it has become one of the leading serum producers. They've already started making the first ready-to-use injections.

Manufacturer usually replies in 22 days

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