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Clinical Manufacturing Services

Integrated CDMO Services for Clinical Drugs

We provide integrated services from formulation research to clinical drug production, and from clinical and licensing to finished product production and reliable commercial supply. With high-level facilities and professional competencies for end-to-end processes, we can efficiently fulfill total responsibilities from preclinical stages to Phase 3 clinical trials and releases.

Extensive Service Coverage

The Genuone Sciences R&D Center supports pharmaceutical research for the full portfolio of formulations required for early-stage clinical trials, including solid dosage drugs, oral liquids, topical dosage, sterile injection and more. Our regulatory affairs (RA) division and clinical pharmacy departments provide consulting and agency services for clinical and licensing trials, informed by our wide-ranging experience and data. Our Good Manufacturing Practice (GMP)-operated plants in Sejong and Jecheon are equally equipped for large-capacity production as well as for optimized small-scale test and reference drug production for clinical trials. We offer complete service resources, from quality control to producing commercially licensed products.

Industry-Leading Clinical and Commercial Services

We are optimized for GMP-based CDMO services for clinical and commercial production. Services are generally provided based on three steps:

 

• For clinical tests, we produce and package the drugs
• For drug licensing, we produce the drugs and provide quality-related data
• For licensed drugs, we produce the drugs for sale and provide quality control services

All of our clinical and commercial medicines are exclusively manufactured at GMP-certified production facilities under strict quality-control management that meets GMP regulatory standards. Our meticulous adherence to quality standards reliably accelerates technology transfers from pilot to commercial scale.

Throughout the process, we focus on flexible supply solutions that prioritize customer needs. The Sejong and Jecheon plants support total supply services based on this flexible approach.

Building on years of process optimization, our plants are currently equipped with state-of-the-art facilities. With a wide range of options capable of producing diverse formulations, we are dedicated to meeting customer needs for developing and producing drugs for specific purposes.

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