Archives for December 11, 2014

From CPHI India

IPA says bad inspectors making Indian manufacturers fear visits

The Indian Pharmaceutical Alliance says the quality of US FDA inspections has “significantly deteriorated” this year, and their approach is creating a climate of fear among Indian manufacturers.

USFDA issues track and trace draft guidance for third-party logistic firms

Third-party logistics providers (3PLs) will have to report annually to the US FDA according to draft guidance published to help implement track and trace legislation.

After AZ R&D exit, CMOs anxious to keep pharma in the country

Pharma companies have called on the Swedish government to prevent manufacturing going the way of R&D and leaving the country, after AstraZeneca closed its research in Lund in 2012.

Peregrine expanding own CMO to make mAb candidate rather than outsource

Peregrine Pharmaceuticals is expanding its contract manufacturing capacity to meet growing client demand and to produce its own monoclonal antibody bavituximab, the company has revealed.