Archives for June 7, 2016

Ko Da not at end of regulatory problems: US FDA says Taiwan firm should hire CFR 211 consultant

The US FDA says Ko Da Pharmaceutical facility in Taoyuan City, Taiwan will not be able to supply the US unless the firm corrects all GMP deviations identified during an inspection last May.

Micro Macinazione opens narcotic and high potency APIs warehouse

Micro Macinazione SA has upped storage capacity with a warehouse for high potency and narcotic drug actives in Molinazzo di Monteggio, Switzerland.

Dispatches from BIO 2016

Brammer Bio opens new cell and gene therapy manufacturing facility

The new 50,000 square foot facility in Lexington, MA will be dedicated to late phase development and commercial manufacturing for advanced cell and gene therapies.

Teva confirms it halted production at Hungary injectables plant in January

Teva has confirmed it stopped making all but two sterile injectable drugs at its plant in Godollo, Hungary in January after a US FDA inspection.

update

TTIP negotiators mull end of duplicate US, EMA facility inspections

Parties negotiating TTIP have discussed measures that would end EMA API and drug manufacturing plant inspections in the US and FDA inspections in Europe.

Dispatches from BIO

Dedicated or condominium? Patheon talks 'creative' capacity models at BIO

With problems in forecasting capacity demand, biopharma is looking to a number of new models from third-party manufacturers according to Patheon.