PaizaBio has secured approval from China’s FDA (CFDA) to add new aseptic injectable production capability at its production facility in Hangzhou, China. This expansion will increase the contract manufacturing organization’s (CMO) annual fill-and-finish capacity from 300 million units annually to 400 million, including vials, pre-filled syringes and cartridges.
PaizaBio Founder and CEO Stuart Rose said the capacity will focus on small molecule drugs for clinical trials and small batch production. He anticipates PaizaBio will reach full-scale production by first quarter 2017 and is well timed for the emerging global market.
“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.”
In this vein, 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.
Rose said the decision to expand PaizaBio’s capabilities and capacity is also the result of recent CFDA policy changes that provide a fast-track approval process for new, innovative drugs and allow drug innovators to use CMOs to commercialize new drugs in China, for the Chinese market, whether the innovators are Chinese or multi-national pharmaceutical companies (MNCs).
In an effort to significantly broaden access throughout the country, China has also pushed for lower drug pricing as it expands health care to all 1.4 billion citizens.
“China is signaling that it is open for business in the pharmaceutical sector to those companies that understand and ‘play’ by the new rules,” Rose said. “We are very pleased to secure the CFDA’s approval and to be at the forefront of this new era in China.”
PaziaBio’s current contract manufacturing capabilities in China include aseptic fill-and-finish for biologic and small molecules clinical trial and commercial scale, lyophilization, packaging, warehousing and logistics, and a newly formed consultancy.
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