Adding Capacity to Global Manufacturing Network
In April 2020, we opened our new excipient and API manufacturing plant in Nantong, China. With this new facility, we have added significant capacity to our global manufacturing network and enhanced supply reliability. In addition to providing multi-compendial Emprove® Excipients and APIs, the expansion in China further strengthens our ability to keep pace with evolving regulatory requirements such as the Chinese co-review registration for excipients. Currently, there are four manufacturing lines that run in parallel and have been commissioned and qualified. The facility also includes space to accommodate additional manufacturing lines to address future demand.
Quality Leadership
Good Manufacturing Practices (GMP) are applied according to the IPEC - PQG Joint GMP Guide for Pharmaceutical Excipients, and ICH Q7, GMP Guide for APIs. It has been ISO 9001 and EXCiPACT™ certified and meets the rigorous standards of our Emprove® Program. Additionally, the facility is equipped with class D paper-free filling rooms, enabling us to offer a wide range of packaging options from small size to big-bag to suit your every need.
Regulatory Excellence
Furthermore, expanding our global manufacturing footprint into China further strengthens our ability to keep pace with the evolving regulatory requirements such as the Chinese co-review regulation for excipients.
Learn more on our website: www.merckmillipore.com/DE/de/...
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12 авг 2021
