Expansion of Production Capacity for Inorganic Salts
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.
Please refer to our Nantong FAQ for further information.
In this plant, Good Manufacturing Practices (GMP) are applied according to the IPEC–PQG Joint GMP Guide for Pharmaceutical Excipients, and ICH Q7 GMP Guide for APIs. Nantong facility has been ISO 9001 and EXCiPACT™ certified and meets the rigorous standards of our Emprove®
Program. Additionally, it 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.
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.
Products in scope:
||Ammonium sulfate EMPROVE® EXPERT ChP,NF,ACS
||Sodium acetate trihydrate EMPROVE® EXPERT Ph Eur,BP,ChP,JP,USP
||Sodium acetate trihydrate for sampling only EMPROVE® API Ph Eur,BP,JP,USP,FCC,E 262
||Zinc chloride EMPROVE® EXPERT Ph Eur,BP,USP
||Sodium sulfate anhydrous EMPROVE® ESSENTIAL Ph Eur,BP,ChP,USP,E 514
||Sodium sulfate anhydrous EMPROVE® EXPERT Ph Eur,BP,ChP,USP
||Sodium acetate anhydrous EMPROVE® ESSENTIAL ChP,USP,FCC,E262
||Sodium acetate anhydrous EMPROVE® EXPERT ChP,USP
||More products to come …