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Roxadustat manufacturers

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roxadustat

Tablets, film coated 20 mg, 50 mg, 70 mg, 100 mg, 150 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Turkey
GMP approvals
FDA, EU GMP
Unavailable markets
Iraq
Comments
Ref. Evrenzo / Astellas PRODUCT PROTECTION EXPIRATION (EU) 2031 (ME) / 2029 (SPC). In-House API
Manufacturer #13072
This pharmaceutical company, established in 1958, boasts a long history and operates across multiple regions, including Europe and North America. They specialize in the production of prescription medications, with a focus on three key therapy areas: oncology, immunology, and dermatology. Their principal dosage forms include tablets, capsules, and topical solutions. The company possesses GMP certifications and holds patents for several product innovations. With three production facilities and a logistics center, they prioritize efficiency and international expansion, aiming to become a global leader in the pharmaceutical industry.

roxadustat

Capsules 20 mg, 50 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
EU GMP
Manufacturer #39894

roxadustat

Capsules 20 mg, 50 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
China
Manufacturer #16160

The company is a leading integrated pharmaceutical group specializing in traditional Asian medicine, chemical medicine, and biopharmaceutical products. It operates multiple subsidiaries and is recognized as a top innovator with state-of-the-art research facilities, including national engineering and technology centers. The company collaborates with over 100 research institutions globally and has received prestigious national awards for technological innovation and scientific progress. It maintains high standards of quality with certifications from ICH, FDA, and EDQM, and has passed national GMP authentication. The company focuses on innovation and service, aiming to strengthen its position in chemical pharmaceuticals, traditional Asian medicine, and biopharmaceuticals.

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