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Regis Passes Inspections to Manufacture Ampyra

Regis Technologies, Inc. received an Establishment Inspection Report (EIR) from the FDA stating that the company has passed pre-approval inspection (PAI) for the manufacture of 4-Aminopyridine, the active ingredient in Ampyra.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Regis Technologies, Inc. received an Establishment Inspection Report (EIR) from the FDA stating that the company has passed pre-approval inspection (PAI) for the manufacture of 4-Aminopyridine, the active ingredient in Ampyra.

Acorda Therapeutics received FDA approval of Ampyra on January 22, 2010, as a treatment to improve walking in patients with multiple sclerosis (MS). Ampyra is an oral, sustained-release tablet formulation of 4-aminopyridine. The FDA inspected Regis’s facility for seven days in April and May 2009 and the EIR and PAI approvals were issued in November 2009.

“We are thrilled to see Ampyra receive FDA approval as a treatment that may help the many people with MS with walking impairment. Regis is proud to partner with Acorda and looks forward to continuing collaborations in the development of life-changing therapeutics,” said Louis Glunz IV, president of Regis Technologies.

Click here for more information about Regis

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