Biologics, Biosimilar, & Pharmaceutical products
The company will specialize in the development and contract manufacturing of biologics bio-similars, and pharmaceutical products. 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. The services will range from Phase I studies to commercial manufacturing operations.
Contract Manufacturing Operations
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. We provide Pharmaceutical-product services including: stability, preclinical, and clinical studies.
GK CMO offers sterile
manufacturing services from Phase I through Commercial.
Our manufacturing facilities will house a
research and development laboratory for new products,
2,000L fermenters/ reactors max / trate
Quality Control Lab.
Stability Rooms, and Clean Room Manufacturing Suites
We have the capability for other Trane that is use for the 2,000L + chemical drug substance manufacturing.
For any inquiries, questions or commendations, please call: 787-509-6471 or fill out the following form
Barrio Coto Norte, Carr. 2 km 45.7
Manatí, Puerto Rico 00674
For career opportunities, please send a cover letter together with your C.V. to:
Be sure to include the area of work you are applying for to the subject matter in the email.