PaizaBio gain approval from CDFA to expand capabilities and capacity in China

Contract manufacturing organisation PaizaBio has secured approval from China’s FDA (CFDA) to add anew aseptic injectable production capability at its facility in Hangzhou, China.

The expansion will increase the company’s annual fill-and-finish capacity from 300 million units to 400 million, including vials, pre-filled syringes and cartridges.

The capacity will focus on small molecule drugs for clinical trials and small batch production.

PaizaBio founder and CEO Stuart Rose said: “We are very pleased the CFDA has given its approval. Not only does it reflect the CFDA’s confidence in our quality standards in the very challenging aseptic fill-and-finish arena, it also reflects China’s focus on becoming a leader in the global pharmaceutical industry, which includes biologics and biosimilars.”

PaizaBio has undertaken plans to expand its newly operational clinical trial capability in biologics to full commercial-scale aseptic manufacturing in the very near future.

The decision to expand the PaizaBio’s capabilities and capacity is in part due to recent CDFA policy changes which provide quick approval process for new drugs and allow drug developers to use CMOs to commercialise new drugs in China.

China has also pushed for lower drug prices to broaden access to healthcare for all of its 1.4 billion citizens.

Rose said: “China is signalling that it is open for business in the pharmaceutical sector to those companies that understand and ‘play’ by the new rules. We are very pleased to secure the CFDA’s approval and to be at the forefront of this new era in China.”