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Mitomycin manufacturers

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Country of origin : India

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14 products found

mitomycin

Injection 2 mg, 10 mg, 40 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #20510

This CTD dossier owner and manufacturer specializes in oncology medications, with a focus on providing high-quality products that meet international pharmaceutical standards. They operate dedicated oncology units certified under both EU GMP and WHO GMP guidelines to ensure consistent quality across their range of products. Their key therapy areas likely revolve around cancer treatment, and they offer various dosage forms to address diverse patient needs. The company is committed to regulatory compliance, working closely with local and international bodies to maintain approvals for all their medications.

Manufacturer usually replies in 2 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 7 days

mitomycin

Vials, lyophilized injection 5 mg, 10 mg, 20 mg, 40 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #30013
The company, established in 2016 and later restructured as a private limited entity in 2018, specializes in manufacturing APIs, advanced intermediates, and finished dosage forms. With robust relationships in the pharmaceutical industry, it has built a strong customer base of over 50 clients and achieved an annual turnover exceeding 200 crore. The company operates extensive facilities capable of scaling from lab-scale development to bulk production, supporting its global expansion strategy. Committed to ethical practices and social responsibility, the company aims to make healthcare affordable and accessible worldwide, with export markets across Asia, Latin America, and Africa.

Manufacturer usually replies in 2 days

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