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neratinib

Tablets, film coated 40 mg, 80 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #287

A globally-oriented pharmaceutical manufacturer operating with integrated in-house development and supply chain capabilities for pharmaceutical products. The company offers over 180 medicines across more than 10 dosage forms (tablets, capsules, powders, drops, inhalers, patches, eye-drops) and serves markets in more than 80 countries. Its manufacturing network includes a European production site with EU batch testing and release of pharmaceutical products, and a specialised facility in India for high-potency drugs under a GMP-compliant environment.

Manufacturer usually replies in 15 days

neratinib

Tablets 40 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
China
GMP approvals
China
Manufacturer #31065

This biopharmaceutical company specializes in the research, development, production, and marketing of recombinant protein therapeutics and microecological agents. They focus on treating a range of conditions including antiviral, oncology, immunology, hematology, digestive disorders, and degenerative diseases. The company boasts seven world-leading technology platforms, including recombinant protein secretion and expression, long-acting recombinant proteins, and antibody technology. Their product portfolio includes recombinant protein therapeutics such as Human Erythropoietin (EPOSINO), Human Interferon α1b (SINOGEN), and Human Granulocyte Colony-stimulating Factor (WHITE-C), as well as the microecological agent "Combined Clostridium Butyricum and Bifidobacterium (CLOBICO)". The company has a strong presence in major markets such as North America, the EU, Brazil, the Philippines, and Indonesia.

Manufacturer usually replies in 6 days

neratinib

Tablets 240 mg

Dossier type
CTD
Dossier status
Under development
Country of origin
Argentina
GMP approvals
PICS
Manufacturer #16454

A pharmaceutical company based in South America with 15+ years of experience in a drug market. More than 40 products in 25+ countries: LATAM; Wester, Southern and South-eastern Asia. Company’s therapeutic areas consist of products that can used in such areas as: urology, oncology, rare diseases and more.

Manufacturer usually replies in 7 days

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