Location: Yinan Industrial Zone, Yiwu City, Zhejiang Province, China.

General overview:

This is one of our 2 "partner sites", & the one solely producing all of our cGMP Active ingredients & intermediates. The site team is 220 people in total, most of them focused on scale-up optimization & commercial production. On-site, a regular line of 15 different active ingredients are produced, in addition to various GMP intermediates. The site operated according to the highest quality & cGMP principles, & has achieved many successful regulatory agency & customer inspections. We've been working closely together for more than 10 years time, & in reality working as one team, sharing each project's daily tasks.

The research & development team is comprised of 15 chemists, led by Dr Ping Lu, who is well-known in china for her accomplishments, after receiving her PhD from University of Southern California USA. Project scope typically includes both designing & developing/optimizing 5-15 steps of chemistry towards a unique molecule which is intended to be scaled-up & produced under western cGMP conditions. There are no chemistry limits, & the team is very skilled at both designing & developing lengthy & challenging chemistry routes.

This facility site(73,000m2) itself offers continuity of scale including gram-scale R&D, & both pilot & commercial production(up to 5000L reactors). It also includes a separate multi-purpose production facility to cost effectively manage the non-GMP part of the synthesis. Special commercial capabilities on-site include "low temperature" & "hydrogenation", & pilot scale "silica purification". Chemists have access to the full range of analytical & literature searching tools, in order to ensure the best process is designed & efficiently developed. All personnel are thoroughly trained on the concepts of western project confidentiality expectations, & the employment requirements are strictly re-enforcing these same expectations.

The site has been approved by our multinational innovator pharmaceutical customers, to make both intermediates & active ingredients. Over the years, this has given us a broad range of experience to apply to early Pre-chinical/Phase I projects, as well as Phase III to commercial. Combined, our synthesis R&D, cGMP production, & analytical characterization/preformulation R&D work, give us the full range of services to offer in this area.