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Mitomycin manufacturers

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Country of origin : India

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14 products found

mitomycin

Vials, injection 2 mg, 10 mg

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

mitomycin

Injection 5 mg, 20 mg, 40 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
WHO
Manufacturer #1356
The company, established in 2005, focuses on generic pharmaceuticals, particularly in niche segments like oncology, CNS, gastroenterology, and anti-diabetics. Specializing in the development of finished formulations and product dossiers, the company prepares for upcoming patent expirations to expand its market presence. With state-of-the-art, WHO-GMP certified manufacturing facilities across the country, the company supplies high-quality formulations globally under its own license and through contract manufacturing. Committed to improving quality of life, the company emphasizes innovation and consistency in its product offerings, aiming to meet the specific needs of diverse markets worldwide.

Manufacturer usually replies in 10 days

mitomycin

Injection 5 mg, 20 mg, 40 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Unavailable markets
United States
Comments
Available Only For Non-USA
Manufacturer #28190

This privately held company develops, manufactures, and commercializes high-quality, affordable generic pharmaceuticals globally. Their focus is on products with formulation challenges and first-to-market opportunities within the generic space. Key therapeutic areas include those requiring complex formulations like injectables, sterile ophthalmic, and dermal products. They specialize in solid oral dosage forms through partnerships with other manufacturing facilities. The company holds GMP certifications and has a track record of developing patented product formulations. Their main production facility in North America is equipped for multi-format packaging and end-product release testing, ensuring a seamless process from bulk manufacturing to finished goods.

Manufacturer usually replies in 54 days

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