Regis Technologies' 4-Aminopyridine manufacturing facility receives FDA's EIR and PAI approval

Regis Technologies, Inc., a leading provider of cGMP and non-GMP synthesis and separations services for active pharmaceutical ingredients (APIs) and intermediates, announced it has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) stating that Regis passed the FDA’s pre-approval inspection (PAI) for its manufacture of 4-Aminopyridine the active ingredient in Ampyra™.

“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”

Acorda Therapeutics’ drug, Ampyra™, was approved by the FDA on January 22, 2010, as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. The FDA inspected Regis’s facility for seven days in April and May 2009. The EIR and PAI approval was 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.

Ampyra ™ is an oral, sustained-release tablet formulation of 4-aminopyridine, which in laboratory studies has been found to improve impulse conduction in nerve fibers where the insulating layer, called myelin, has been damaged. Regis initially developed the synthesis for 4-aminopyridine more than 25 years ago, when the compound was first investigated at Rush’s Hospital in Chicago. It currently holds the U.S. and several foreign drug master files (DMFs) for this compound.

Regis Technologies, which increased its facility to 51,000 square feet in 2009, also passed its general inspection by the FDA, conducted during the same period as the pre-approval inspection.