MCP Pharmaceuticals Announces Successful Completion of FDA and EMEA GMP Audits
PARSIPPANY, NJ MAY 10 2010
MCP Pharmaceuticals’ sterile manufacturing site based in Rochester, Michigan completed a successful GMP (Good Manufacturing Practices)/Pre Approval Audit by the U.S. Food and Drug Administration (FDA) drug division (CDER).
This audit followed two successful GMP audits in 2009 including an audit by the FDA biologics division (CBER) and an audit by the European Medicines Agency (EMEA), which resulted in a continuance of the certificate of GMP compliance for the manufacturing site.
Stuart Hinchen, co-founder and President of MCP stated, “We are extremely pleased with the results of the recent audits of our Rochester, Michigan sterile injectable manufacturing facility. We understand the importance of compliant quality systems and we work diligently to maintain these systems to the highest global standards.”
About MCP Pharmaceuticals, LLC MCP Pharmaceuticals, headquartered in New Jersey, is a specialty pharmaceutical company that manufactures and sells sterile injectable products for the hospital market segment, and provides contract manufacturing of sterile injectable products for innovator pharmaceutical and biotech organizations.
MCP markets 14 branded pharmaceutical products through its national sales and marketing infrastructure and contract manufactures both pharmaceutical and biotechnology products for small and large proprietary pharmaceutical and biotechnology companies. MCP employs more than 330 staff in the USA in its manufacturing, sales & marketing and corporate areas. MCP is a private company wholly owned by MCP Holdings, LLC. For more information, please visit jhppharma.com.
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