With the serialization deadline approaching, Sovereign Pharmaceuticals implemented open-source software that allows the company to make their own changes and improve packaging efficiency.
Keren Sookne
Jan 16th, 2020
Sovereign Pharmaceuticals, LLC is a CDMO specializing in small-batch prescriptions drugs, packaging solid and liquid products in their Ft Worth, TX, facility. They handle a variety of bottle sizes—from 50 cc up to 950 cc and from 1 oz to 16 oz—for a number of drugs and indications. Dealing with several virtual companies for clients, they spend a lot of time educating them about regulatory requirements.
In 2016, the company sought a serialization solution to meet the DSCSA enforcement date in Nov. 2018. While they were driven by regulations, meeting the deadline appeared it would be a challenge. “We tried one solution and our customers tried three other solutions and none of them were going to meet the deadline,” says Ryan DeSario, Serialization Supervisor at Sovereign.
