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None products found
Few EU CTD dossiers available

daunorubicin + cytarabine

Vials, injection 44 mg + 100 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
FDA, EU GMP, ANVISaudi Arabia, Libya, Saudi Arabia, South Korea, Turkey
Comments
Dossier Status: Upon request.Reference product: Vyxeos
Manufacturer #11907
A pharmaceutical manufacturer based in the EU that is active in 40+ countries selling its products for 20+ years. Key production lines include Rx, OTC, medical devices, and cosmetics. The company's production lines are EU GMP-compliant. The company owns branches in the EU, North America, and Africa.

Manufacturer usually replies in 39 days

cytarabine

Injection 100 mg/5 ml,500 mg/5 ml

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Comments
Under Stability Study
Manufacturer #34048

Established in 2004, this pharmaceutical manufacturer specializes in producing liquid orals, cephalosporin tablets, capsules, dry powder syrups, dry powder injections, liquid injectables (SVP) in ampoules and vials, and lyophilized injections. As a CTD dossier owner and manufacturer, it holds multiple GMP certifications, including EU GMP, ISO 9001:2015 (BVQI), WHO-GMP, and cGMP. Additionally, its facilities are approved by national drug authorities in countries such as Uganda, Kenya, Yemen, Ethiopia, Congo, Ghana, Zimbabwe, Cambodia, Vietnam, Malawi, Namibia, Nigeria, Côte d'Ivoire, the Philippines, and Peru. The manufacturer operates advanced production lines adhering to stringent GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed across over 50 countries globally, with 292 registered products and an additional 210 products under registration.

Manufacturer usually replies in 6 days

cytarabine

Injection 100 mg/ml, 500 mg/5 ml, 1000 mg/10 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, PICS, MHRA, WHO
Manufacturer #38657

The company is a pharmaceutical manufacturer engaged in the development, production and export of a range of pharmaceutical products across key therapeutic segments including oncology, critical care and lifesaving medicines, operating with certified manufacturing capabilities and global distribution networks to supply these pharmaceutical products to international healthcare markets.

Manufacturer usually replies in 7 days

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