cGMP API Manufacturing
CiVentiChem’s global headquarters in Cary, North Carolina is also the location of our cGMP, FDA registered facility. The focus of our GMP laboratory is to provide High Value, Low Volume APIs, especially difficult to manufacture, high barrier to entry compounds.
We have the ability to manufacture most NCE and Generic compounds up to and including many rated SafeBridge III and offer production ranging from Clinical Supplies through kilo-scale commercial production. To support our cGMP manufacturing we offer all the necessary documentation to support your regulatory filings.
Our culture of regulatory excellence includes filing multiple DMFs for clients and successful FDA PreMarket Approval Inspection with no 483’s.
Let us be your partner of choice for cGMP Manufacturing of High Value, Low Volume APIs.
Contact Us to discuss your NCE, Generic, or Orphan Drug API process development and manufacturing needs or for more information on the APIs CiVentiChem has developed in house.