According to Edge, with the new FDA and state 503B outsourcing laws, the pharmaceutical industry is in a transitional period, since it is no longer legal to purchase many medications from traditional compounding pharmacies for office or hospital use, which is precipitating a large increase in the need for FDA registered and inspected facilities capable of keeping up with the demand. Included in Edge's expansion plan is the introduction of robotics into the manufacturing processes. Typically reserved for traditional pharmaceutical manufacturing, bringing industrial automation to the 503B outsourcing space is a critical step to providing customers with not only the necessary throughput, but the assurance that quality and repeatability are built into the basic operations of the manufacturing process.
This will allow it to keep pace with the production demands, while also passing along the benefits of economies of scale to its customers in the form of reduced costs. It says, like any other industry, as volumes increase the justification for automation becomes easier, which in turn results in lower costs for the customer.
The company says it has been diligent in complying with new rules and regulations implemented by the Boards of Pharmacy, the Food and Drug Administration, USP-795, and USP-797. In the last 3 years, Edge has completed two FDA inspections and 7 Board of Pharmacy inspections.