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With July 2013 Deadline Looming, Debate Continues Over How to Require GMPs for APIs in Europe

 
• By Bowman Cox

As Europe prepares to subject API imports to GMP controls, industry urges a different approach. Questions linger over how to keep Anti-Falsification Directive from drying up Europe’s API supplies.

The European Commission came under fire last month for the way it is proposing to extend European GMP requirements to active pharmaceutical ingredients.

There is a concern that the proposal could prevent Europe from importing APIs from India and China, where most of them are made, after new import controls take effect in...

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• By Laura Helbling

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