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ganirelix acetate

Injection 0.25 mg/0.5 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
EU GMP
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.

Manufacturer usually replies in 81 days

ganirelix acetate

Injection 250 mcg/0.5 ml

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
China
Manufacturer #18656
This China-based firm provides comprehensive regulatory and market-entry services for pharmaceutical products, offering support that spans API and finished-dosage registration, DMF and CTD preparation, clinical and marketing-authorization submissions, and the sourcing and registration of APIs, reference substances, impurities, excipients, and intermediates, while also delivering translation, dossier development, and quality-review services that assist any pharmaceutical manufacturer seeking compliance within the Chinese market.

Manufacturer usually replies in 43 days

ganirelix acetate

Injection, pre-filled syringe 250 mcg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
FDA
Manufacturer #36628

Established in 1986, this manufacturer employs approximately 1,451 individuals and specializes in heparin-related products, including standard heparin and low molecular weight heparin. As a CTD dossier owner and manufacturer, it holds GMP approvals from multiple countries, ensuring compliance with international quality standards. The manufacturer operates advanced production lines for both active pharmaceutical ingredients and finished dosage forms, adhering to stringent GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed in over 60 countries worldwide

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