Global API developer and manufacturer, Sterling Pharma Solutions, has experienced growth in the Japanese market as a result of its technical capabilities and innovation strategy.

The contract development and manufacturing organization (CDMO) now works with a number of clients in Japan, including two big pharma companies, providing services such as fluorination, hazardous chemistry and continuous processing.

Sterling’s technology and innovation strategy, which has seen them win two major contracts in Japan in 2017, is designed to ensure it is at the forefront of new developments in API manufacturing.

As part of this, the company works with a number of academic organizations on several projects, including a fluorination project with Professor Graham Sandford at Durham University and a continuous processing project with John Blacker at Leeds University. It also works with specialist technology companies, including Prozomics and Nzomics Biocatalysis at Northumbria University.

Its partnerships with these organizations mean that Sterling can utilize their small-scale capabilities during proof of concept (POC) work, then scale-up and industrialize the processes to deliver APIs to market.

“Japan is the third largest pharmaceutical market in the world and over the last few years we have seen a lot of development in the innovator API space,” said Kevin Cook, chief executive officer, Sterling Pharma Solutions. “Sterling is strong when it comes to managing the challenges associated with innovator APIs and this is largely due to our commitment to developing and utilizing new technologies to deliver complex molecules with quality output on time.

“Japanese pharmaceutical companies have tended to manufacture most of their products in-house. However, with cost pressures continuing to increase and the growing emerging pharma sector in Japan; the outsourcing market is rapidly maturing to provide increasing opportunities for CDMOs.”

The company has plans to expand its presence further in this market and recently appointed a representative to drive business development in Japan.

Koichi Hirayarma has over 40 years’ experience across the pharmaceutical, healthcare and chemical industries and has previously held positions at Johnson & Johnson and Showa Denko K.K. His main responsibilities include driving Sterling’s sales activity in Japan and acting as a point of contact for the CDMO’s clients in this market.

Mr. Hirayarma said, “The Japanese market is heavily concerned with quality, which is an area that Sterling excels in. The company’s regulatory compliance record, combined with access to the latest technologies, make Sterling an ideal service provider for Japanese companies. I look forward to continuing to grow its presence in this market.”

Sterling Pharma Solutions has been successfully audited by the Pharmaceutical and Medical Devices Agency (PDMA) in Japan.

Sterling’s site in the North East of England was founded in 1969 and has a strong heritage in API services. The CDMO is the UK’s largest provider of API development and manufacturing services to the pharmaceutical industry.