CFDA Approves Drug Developed with CDMO Support
WuXi STA supported the development of hepatitis drug through marketing authorization holder pilot program.
STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec, announced on June 14, 2018 that its partner, Ascletis, has received approval from China Food and Drug Administration (CFDA) for its Category 1 drug, Ganovo (Danoprevir or ASC08), to treat viral hepatitis C. WuXi STA provided process optimization and process validation support for the active pharmaceutical ingredient (API), as well as new drug application (NDA) submission and approval.
The approval of Ganovo marks the first time a contract development and manufacturing organization (CDMO) in China supported the launch of an innovative drug using the Marketing Authorization Holder (MAH) pilot program, the company reported in a statement.
In December 2017, WuXi STA’s Jinshan API manufacturing site passed the pre-approval inspection by CFDA as part of the Ganovo NDA application process.
Source: WuXi STA
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Drug Solutions Podcast: Applying Appropriate Analytics to Drug Development
March 26th 2024In this episode of the Drug Solutions Podcast, Jan Bekker, Vice President of Business Development, Commercial and Technical Operations at BioCina, discusses the latest analytical tools and their applications in the drug development market.
