As per the agreement, AMRI will offer process development, manufacturing and supply of active pharmaceutical ingredients (APIs) to support the filing of Parnell’s new animal drug application (NADA) with the US Food and Drug Administration (FDA).
AMRI will also support Parnell in the commercial launch of its veterinary product onto the US market pending regulatory approval.
AMRI chairman, president and CEO Thomas D’Ambra said their new relationship with Parnell illustrates again AMRI’s ability to provide integrated support covering development and manufacturing to FDA standards.
"We look forward to working with Parnell to expeditiously achieve regulatory approval, a successful project launch and great success in the US market," D’Ambra said.