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Amifostine manufacturers

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Country of origin : India

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5 products found

amifostine

Injection 500 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP, PICS, COFEPRIS, MHRA, Canada, South Africa, United Arab Emirates, Turkey
Manufacturer #36255

Established in 2013, this manufacturer specializes in oncology, focusing on the research, manufacturing, and marketing of high-quality specialty formulations. As a CTD dossier owner and manufacturer, it holds GMP certifications from international regulatory authorities, including USFDA, MHRA, and PIC/S, ensuring compliance with stringent quality standards. The manufacturer operates a state-of-the-art facility in Hyderabad, India, designed to meet global regulatory requirements. As a CTD dossier owner and manufacturer, its products are distributed worldwide. With a commitment to innovation and quality, the manufacturer aims to provide the best options to oncologists and their patients.

Manufacturer usually replies in 32 days

amifostine

Injection, lyophilized 500 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
PICS
Manufacturer #36647

Established in 2018, this manufacturer specializes in oncology, anti-cancer, cytotoxic, critical-care, life-saving, and general injectables, as well as oral solids like tablets and capsules. As a CTD dossier owner and manufacturer, it exports products to over 30 countries across Asia, Africa, LATAM, CIS, MENA, and Europe. Operating under WHO-GMP and PIC/S certifications, the GMP manufacturer maintains advanced production lines for liquid injectables, lyophilized injectables, pre-filled syringes, tablets, and capsules. As a CTD dossier owner and manufacturer, it upholds stringent quality standards and regulatory compliance

Manufacturer usually replies in 46 days

amifostine

Injection 500 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
WHO
Manufacturer #31073

This pharmaceutical company specializes in oncology and has nearly two decades of experience developing generic and specialty drugs. They focus on delivering affordable, world-class chemotherapy medications across a wide range of therapeutic areas. Their robust research and development team possesses expertise in complex drug molecule development, serving diverse markets globally. With over 35 developed generics and specialty drugs, they have filed over 40 dossiers across 25 countries in emerging markets. The company is committed to expanding its presence in the oncology therapeutic area within emerging markets.

Manufacturer usually replies in 48 days

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