CiVentiChem has received its first U.S. Food and Drug Administration approval for a generic commercial active pharmaceutical ingredient (API) manufactured at its Cary headquarters.

CiVentiChem established its contract development and cGMP (contract Good Manufacturing Practices) production of small molecules and active pharmaceutical ingredients (APIs) for drug companies at its Cary location in 2012. It provides both generics and clinical supplies.

The company also has a large-scale manufacturing plant in Hyderabad, India.

“This commercial approval validates CiVentiChem as a quality, U.S.-based API manufacturer,” said Bhaskar Venepalli, Ph.D., MBA, FRSC, president and CEO. He noted that the FDA most recently inspected CiVentiChem in April of 2015 with no findings of violations – citations sometimes issued to problem companies dubbed “483s.” The Drug Enforcement Agency also recently approved CiVentiChem as a manufacturer of controlled substances.

CiVentiChem continues to expand GMP capabilities in North Carolina including the addition of a new, larger-scale, GMP suite expected to begin operations in July 2017. The company is also expanding its quality assurance and quality control departments to support this new capacity.

“We continue to work with several generic and innovator companies on their complex APIs and look forward to the continued expansion of our pipeline and GMP capabilities” said CiVentiChem Executive Chairman Tony Laughrey.

CiVentiChem focuses on high-value, low-volume APIs and complex chemistries. Service offerings include cGMP manufacturing, process development, and custom synthesis for pharmaceutical, biotechnology, and other life science companies.

Founded in 1994 by Venepalli and Duke University scientist Srinivas Chittineni, Ph.D., the company now employs 20 people at the Cary headquarters. Venepalli is a member of the North Carolina Biotechnology Center board of directors.

(C) N.C. Biotechnology Center