Celltrion confident in quality of biosimilar supply despite US FDA 483
Celltrion Inc has received a FDA Form 483 with 12 observations but remains confident no exported biosimilar products have any quality issues.
Archives for September 6, 2017
Shimadzu buys CDMO AlsaChim
Shimadzu has acquired French radiolabelling contractor AlsaChim.
Ageing facilities & drug shortages: industry concern drives guidance for manufacturers
The Parental Drug Association (PDA) is offering guidance to drug makers with ageing, sometimes non-compliant facilities, which it hopes will help combat drug shortages.
Clintec’s research site boost at Scotland HQ
Clintec International has opened a centre of excellence for clinical research and quality assurance capabilities as part of its headquarters expansion in Glasgow, Scotland.
When is a commercially available chemical not "commercially available"? ICH issues new Q11 Q&A
The ICH has sought to clarify how API and drug firms should source and justify their starting materials under Q11 guidelines.
Cadila says Moraiya drug plant has passed US FDA inspection
Cadila Healthcare says its formulation plant in Moraiya, Gujarat has passed a US Food and Drug Administration (FDA) inspection with no Form483 observations.
PSI CRO opens in Seoul with sites across South Korea
There are many opportunities in Asia Pacific for mid-sized CROs says PSI, after opening a new office in Seoul, South Korea in response to client requests.