Address: Barrio Coto Norte, Carr. 2 km 45.7, Manatí, Puerto Rico 00674
Email: info@gkcmo.com
Tel: (787) 621-1818
Website: https://gkcmo.com
Company information
GK Pharmaceutical Contract Manufacturing Operations “GK CMO”, is a contract manufacturing Plant performing cGMP contract manufacturing services. These include: aseptic filling of parenteral for Biologics, bio-similars, drug substances, and solid dosage finishes. GK provides Pharmaceutical-product services including stability, preclinical, and clinical studies. GK CMO offers sterile manufacturing services from Phase I through Commercial.
GK CMO will aim to help clients enter the U.S. market by providing the development, manufacturing and regulatory approval services with the Federal Drug Administration (“FDA”) and other regulatory agencies for pharmaceutical companies.
GK CMO just broke ground with its new manufacturing facilities in the summer of 2019, and will be the first and only Pharmaceutical and Biotechnology company in Puerto Rico to have the technology and capacity to manufacture Biologics, Bio-similars, Drug Substances, and Solid Drug products within the same facility.