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niraparib

Tablets 100 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 26 days

niraparib

Capsules 100 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Manufacturer #10856

It is a pharmaceutical manufacturing company offering unique services covering a strategic base for the development of generics and ‘Day 1’ launch into the EU and beyond. Established in the 2000s, with a considerable investment of founding energy, expertise, and resources. The company boasts a state-of-the-art facility, infrastructure, and high-end equipment, dedicated to high potency ‘contained production’ to supply a range of therapeutic products for world markets.

niraparib

Capsules 100 mg, 200 mg, 300 mg

Dossier type
EU CTD
Dossier status
Under development
Country of origin
Turkey
GMP approvals
FDA, EU GMP
Comments
Ref. Zejula / Tesaro (GlaxoSmithKline) PRODUCT PROTECTION EXPIRATION (EU) 2032
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.

Manufacturer usually replies in 13 days

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