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Nitisinone manufacturers

9 products found

Filters

9 products found

nitisinone

Capsules 2mg, 5mg, 10mg, 20mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Canada
GMP approvals
EU GMP
Manufacturer #16649
It is a pharmaceutical company dedicated to the treatment of rare diseases. A rare disease is any disease that affects a small or very small percentage of the population. It is estimated that more than 300 million people worldwide are living with one of the 7,000 diseases they define as rare.

nitisinone

Capsules 5 mg, 10 mg, 20 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Turkey
GMP approvals
EU GMP
Unavailable markets
Albania , Bosnia And Herzegovina , Bulgaria , Costa Rica , Kosovo , Serbia , Slovenia
Registered in
Bulgaria , Switzerland , Turkey
Manufacturer #361

It is a global player with more than half a century of experience. It has more than 4 facilities to operate from. They have marketing and promotion in more than 20 countries. It exports to more than 50 countries. The only motto is to improve the quality of human life and to provide access to reliable, high-quality products for human health worldwide. It is focused to create its own cadres in every country it operates.

Manufacturer usually replies in 33 days

nitisinone

Capsules 2 mg, 5 mg, 10 mg, 20 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #34252

Established in 2004, this vertically integrated pharmaceutical manufacturer is committed to delivering high-quality, affordable medicines globally. As a CTD dossier owner and manufacturer, it holds GMP certifications from the US FDA, EU, and WHO, ensuring compliance with stringent international quality standards. The company's state-of-the-art R&D center is capable of handling oral solids, liquids, and parenteral formulations. Its products have received marketing authorizations from regulatory authorities such as the US FDA, Health Canada, CDSCO-India, and New Zealand. With over 20 ANDA/ANDs under approval, the manufacturer operates advanced production lines adhering to rigorous GMP guidelines. Its diverse portfolio includes therapeutics in areas like antivirals, neurology, women's health, cardiology, and imaging contrast agents.

Manufacturer usually replies in 8 days

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