Onyx plans commercial API manufacture

Onyx Scientific has revealed that it has been engaging with the UK Medicines & Healthcare Products Regulatory Agency (MHRA) with a view to securing a commercial API licence by the end of 2019. It plans to expand its facility at Sunderland to carry out small-scale API manufacture at all stages of development projects, particularly for orphan drugs.

“There is a growing gap in the market for manufacturers that have the niche capabilities to deliver small-scale commercial API projects,” said Denise Bowser, commercial director. “We want to fill that space and remove the need for our customers to seek other partners to help them manufacture their drug substance commercially.”

As part of this, the company will implement Quality by Design and Design of Experiments principles into its API development and manufacturing practices, establishing critical quality parameters for every product. It will recruit to expand its team of scientists, as well as its analytical and quality assurance teams. Onyx added that this will complement commercial-scale manufacturing at the facilities of its parent company, Ipca Laboratories, in India and the US.

In January, Ipca had acquired Pisgah Labs for $9.65 million. Active since 1981, Pisgah is a contract manufacturer and developer of APIs and intermediates at Pisgah Forest, North Carolina. This was Ipca’s first buy in North America. It said at the time that “Onyx and Pisgah’s capabilities in chemistry services will dovetail effectively with our capabilities in supporting Phase I to commercial scale programmes and also enable the company to manufacture small volume APls for the US market”. Exports now account for about 47% of Ipca’s sales.