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.

Facilities Laboratories

Warehousing

Our manufacturing  facilities will house a

• research and development laboratory for new products,

• 2,000L  fermenters/ reactors max / trate

• Quality Control Lab.

•  Microbiological Lab. 

• Stability Rooms, and Clean Room Manufacturing Suites

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 We have the capability for other Trane that is use for the 2,000L + chemical drug substance manufacturing.