Generics 7

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Sapropterin manufacturers

7 products found

Filters

7 products found

sapropterin

Tablets 100 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
Iceland
GMP approvals
EU GMP
Unavailable markets
Kuwait , Qatar , United Arab Emirates
Manufacturer #28915

This company specializes in generic pharmaceuticals within the EU region. They offer out-licensing and contract manufacturing services to pharmaceutical companies seeking high-quality production from a reliable European partner. Their facility utilizes green energy sources, highlighting their commitment to sustainability. While specific therapy areas and product details are not provided, they likely focus on various dosage forms common in generic pharmaceuticals. The company emphasizes its skilled workforce and dedication to employee well-being.

Manufacturer usually replies in 41 days

sapropterin

Tablets 100 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

sapropterin

Tablets, soluble 100 mg

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Comments
Ref. product: Kuvan® BioMarin
Manufacturer #261
A pharmaceutical manufacturer based in the EU that has been selling its products in Europe for 20+ years. Main therapeutic areas include diabetes, CNL, dermatology, and oncology. Main dosage forms include solid and liquid oral, sterile dosage forms, and ointments. The company possesses 10+ manufacturing facilities that are cGMP-compliant.

Manufacturer usually replies in 20 days

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