Vivozon Begins Process Validation for Ophirangerin Injection in the US

[Asia Economy Reporter Hyungsoo Park] Vibozone is accelerating preparations for the commercialization of the non-narcotic analgesic 'Opiranjerin Injection (VVZ-149)'.

On the 24th, Vibozone announced that it has commenced 'Process Validation' for the manufacturing and quality control of Opiranjerin Injection.

Process validation is a necessary step before the commercialization of pharmaceuticals. It objectively verifies and documents whether the product is manufactured according to pre-established standards throughout the entire process from drug manufacturing process development to production stage. The entire process, from manufacturing to documentation, is expected to take approximately eight months.

The process validation is being conducted by a U.S.-based contract manufacturing organization (CMO) that has received approval from the U.S. Food and Drug Administration (FDA). This company was pre-selected by Vibozone in 2019, considering the commercialization stage of Opiranjerin Injection. It produces clinical drugs in compliance with the FDA's current Good Manufacturing Practice (cGMP) standards.

A Vibozone official stated, "We have prepared the necessary data for the commercial mass production of Opiranjerin Injection over a long period in a phased manner." He added, "If the process validation is successfully completed, we will be able to complete the procedures required for commercialization in terms of manufacturing and quality control."

Furthermore, he explained, "We have secured sufficient raw material inventory necessary for mass production of Opiranjerin Injection."

This content was produced with the assistance of AI translation services.