Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.
Imprimis Pharmaceuticals says it is evaluating pursuing New Drug Application (NDA) status for some of its product reformulations through the US FDA 505(b)(2) development pathway.
Reference material manufacturer Chiron AS has been cleared to make carfentanyl for opioid researchers working in Europe.
Pulmatrix Inc has extended its IP portfolio with a European patent for its particle-based drug delivery technology.
Jinan Jinda Pharmaceutical Chemistry Co. Ltd has more to do to bring its drug ingredient plant in Shandong, China up to code according to the US FDA.
The US FDA has called on Indian drug firm USV Private Limited to rethink how its tests for microbial contamination at its manufacturing facilities.
Amgen has signalled its intention to take a share of the $6.9bn Herceptin market by filing its trastuzumab candidate in the EU.