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Nitisinone manufacturers

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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 2 mg, 5 mg, 10 mg

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
United States
Unavailable markets
United States
Comments
Reference: Orfadin®
Manufacturer #17451

A global specialty-focused pharmaceutical manufacturer that develops and supplies complex pharmaceutical products and active pharmaceutical ingredients, with particular emphasis on hospital, autoimmune, rare-disease and pain-management therapies. The company operates a network of cGMP-compliant facilities that are routinely inspected by major regulators, with at least one manufacturing site holding EU-GMP certification and additional approvals from agencies such as the US FDA, Japanese PMDA and UK authorities, supporting reliable worldwide supply of high-value pharmaceutical products.

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.

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