Onyx Scientific, a small molecule API contract development and manufacturing organization (CDMO) has received a commercial API license for its UK facility.

The license, granted by the Medicines and Healthcare Products Regulatory Agency (MHRA), allows Onyx to support API projects from pre-clinical studies to low volume commercial manufacture.

Denise Bowser, commercial director at Onyx, commented, “Over the years, we have worked towards building a strong reputation in helping drug developers with complex chemistry. This commercial API license is incredibly important as it marks the next phase in our growth and enables us to support customers from concept to commercialization. We are now able to fill the gap in the market for small-scale commercial API requirements while maintaining our expertise in delivering early-stage programs.”

With its offering of API development, GMP manufacturing, solid state chemistry and analytical expertise, Onyx continues to experience strong growth driven by demand from biotech and pharmaceutical companies for its integrated CMC capabilities. The company forecasts that the 70-strong team will grow by around 50% in the next three years to support its clinical and commercial API manufacturing capabilities.