Grace’s Fine Chemical Manufacturing Services’ facility in Tyrone, Pennsylvania (CDMO) has more than 40 years of history in custom manufacturing. It offers a blend of chemistry and engineering, more than 80,000 gallons of reactor capacity, the ability to develop continuous processes, and handling of highly hazardous materials as a CDMO.
Grace’s FCMS uses this site to manufacture registered starting materials (RSMs), and it has the capability to produce non-cGMP pharmaceutical intermediates. In fact, through the Tyrone facility, Grace’s FCMS has the unique ability to back-integrate RSMs within North America. Tyrone is particularly well equipped for complex, multi-step synthesis with various materials of construction and covering almost every unit operation available. We also have the capability to handle cryogenic reactions down to –90ºC.
The combination of Tyrone and South Haven custom manufacturing facilities offers U.S. companies the chance to outsource drug substance domestically and structure a simplified supply chain, mitigating the risk of going overseas to source starting materials.
This capability is further supported by the long tenures that Grace FCMS has at both sites and the way the highly experienced teams work together. South Haven provides support for quality assurance across both sites, and the quality management system at Tyrone is aligned to meet FDA and ICH requirements.
HASTELLOY® is a trademark, registered in the United States and/or other countries, of Haynes International, Inc. ROTOFORM® is a trademark, registered in the United States and/or other countries, of IPCO GERMANY GMBH. BRUKER® is a trademark, registered in the United States and/or other countries, of Bruker-Physik GmbH. This brochure is an independent publication and is not affiliated with, nor has it been authorized, sponsored, or otherwise approved by the aforesaid companies.
Our South Haven, Michigan facility is a full-service cGMP manufacturing site, containing everything required to develop APIs to commercialization, with all the necessary support capabilities.Learn more