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Divi's Labs' Vizag plant banned from shipping to US

Indian API firm Divi’s Laboratories has been banned from shipping drug ingredients made at its Vizag plant to the US.

Compounding firm looks at NDA opportunity for reformulation of Mallinckrodt's H.P. Acthar

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.

Chiron AS cleared to make carfentanyl for opioid researchers

Reference material manufacturer Chiron AS has been cleared to make carfentanyl for opioid researchers working in Europe.

Pulmatrix secures EU patent for dry powder delivery tech

Pulmatrix Inc has extended its IP portfolio with a European patent for its particle-based drug delivery technology.

US FDA says Jinan Jinda Pharma must do more make Shandong plant compliant

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.

US FDA criticizes Indian drug firm USV for problems at multiple sites

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 targets Roche in Europe with Herceptin biosimilar submission

Amgen has signalled its intention to take a share of the $6.9bn Herceptin market by filing its trastuzumab candidate in the EU.

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