olaparib Tablets, film coated 100 mg, 150 mg
Dossier type
EU CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
FDA, EU GMP, ANVISaudi Arabia, Libya, Saudi Arabia, South Korea, Turkey
Comments
Reference product: Lynparza.
Patent: EU - 03/2029 (SPC), US - 09/2027 (Patent term extension)
Manufacturer #11907
A pharmaceutical manufacturer based in the EU that is active in 40+ countries selling its products for 20+ years.
Key production lines include Rx, OTC, medical devices, and cosmetics.
The company's production lines are EU GMP-compliant.
The company owns branches in the EU, North America, and Africa.
Manufacturer usually replies in 37 days
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