China-based Suzhou Pharma has set up a US regulatory and QA hub in what it says is a bid to provide Western cGMP (current good manufacturing practice) know-how with low cost Asian production.
Based in Lyndhurst, NJ, the new office will houses regulatory affairs, quality assurance and control (QA/QC), and product development and management, whilst its oral solid dose manufacturing operations remain in China.
And with the changing regulatory landscape – especially since the introduction of the US User Fee Reauthorisation Bill last month – the firm says the move could encourage companies afraid of the increasingly stringent rules in the Asian market to establish operations there.
Marc Finn, senior director of business development for the Amerigen-owned CMO (contract manufacturing organisation) told Outsourcing-Pharma.com: “Perhaps it could be as a solution provider to manufacturing in China for an entrance into the exploding Chinese pharmaceutical market.
“In this instance, our customer has a solution without the need of capital investment in China for a facility, equipment, labour and such, with the additional benefits of speed to market.”
However, when asked if the move is a response to the US FDA’s (Food and Drug Administration’s) User Fee Bill updates, Finn said: “No, our business model was already put into place well before this FDA initiative.
“Our operations in Suzhou are one of China’s first US FDA approved and Chinese SFDA licensed finished product cGMP manufacturing sites.”
Besides gaining new business in the US, the firm now also hopes to expand its customer base locally in China.
“The majority of our customer base and business is based in our backyard in the northeast USA,” Finn told us.
“We can deliver to drug makers not only cost savings and high quality products for Western and Global Markets, but also a local manufacturing solution for access to the growing Chinese pharmaceutical marketplace.”