Xspray Pharma informed of FDA follow-up inspection at contract manufacturer NerPharMa's Italian facility

Xspray Pharma was notified by its contract manufacturer NerPharMa that the FDA has begun an unannounced follow-up inspection at the manufacturer's Italian facility. Approval of its NDAs for Dasynoc and Nilopki remains subject to satisfactory cGMP status at the facility.

Detected & updated continuously · Source: Nebula