Edge Pharma is preparing an ANDA submission for FDA approval of methacholine chloride

Published: September 10, 2019

Edge Pharma, one of the leaders in 503B pharmaceutical outsourcing, is excited to announce that it is preparing the required ANDA submissions to the FDA for approval of a generic methacholine chloride. Methacholine chloride is typically used during a challenge test as a means to diagnose bronchial hyperresponsiveness. According to Edge’s CEO Bill Chatoff,

"Methacholine is the first in a series of ANDAs that is going to become a significant part of Edge Pharma’s 503B strategy in the United States.”

By combining FDA approved drugs within the flexibility of 503B outsourcing, Edge leverages the world-class team and facilities it has developed to bring safe, cost effective solutions across 17 medical specialties.

As the 503B industry continues to mature, Edge sees companies within the segment moving in the direction of having broad ANDA portfolios. Edge itself has a pipeline that includes many ANDA submissions to the FDA over the next three years, allowing the company to continue to deliver creative solutions to compliance challenges across all of healthcare.