Warning Letter Prompts Hikma to Halt Production at NJ Generics Plant

December 28, 2012

Hikma Pharmaceuticals will cease commercial production at its Eatontown, N.J., plant through mid-January to focus on bringing the facility back into compliance with GMP regulations following a February 2012 warning letter.

Further, FDA observations from a recent inspection showed additional compliance work is required and halting production will allow it to be completed faster, Hikma said. The company could not be reached for additional information on the planned compliance fixes.

The remediation and additional restructuring for its generics business are expected to cost about $5 million this year, the company said.

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