Custom API Manufacturing
Tailored API manufacturing CDMO services
At all scales, our team provides a complete and custom solution, seamlessly managing supply chains and innovating to reach our clients’ API manufacturing goals. We have the infrastructure and expertise to support everything from pilot production to large-scale commercial API manufacturing.
Manufacturing for Clinical Trials
Manufacturing for Clinical Trials
Our clinical trial materials manufacturing services are designed with agility in mind, helping clients stay resource-efficient from pilot production to NDA submission. We’re here to guide you through each phase.
Pharmaceutical Validation & Commercial Launch
Let’s do it right the first time around. SK pharmteco is a steadfast partner as your compound powers towards a new drug application (NDA) and commercial launch. We have experts across all the key disciplines, from chemistry to regulatory, to guide market entry.
Commercial Manufacturing & Lifecycle Management
Our experienced team can streamline commercial manufacturing for the full lifecycle of the drug. This includes exploring new opportunities to lower API costs and improve overall efficiency, without deviating from registered processes or risking product quality.
CGMP Facilities Supporting API drug development
Key Facilities: United States
SK pharmteco has a portfolio of top-tier facilities throughout the U.S. This includes our 240-acre California headquarters, which performs fully CGMP-compliant manufacturing from laboratory to commercial scale with over 81,930 gallons (310 m³) of manufacturing capacity. Our Texas plant also supports small- and large-scale CGMP manufacturing with specialized expertise in large-scale energetic and hazardous chemistry.
Specialized CGMP Manufacturing Facilities
Key Facilities: Korea
Our manufacturing footprint in Korea includes two core facilities: Sejong and Daejeon. Built in 2017, the Sejong Plant operates with a high level of automation and optimized processes, including both batch and continuous flow processing. Among other services supporting commercial API and intermediate production, our Daejeon location is home to our Process R&D Center.
CGMP Facilities Supporting API drug development
Key Facilities: Ireland
SK pharmteco continues to invest in our Dublin, Ireland facility, recently undertaking a significant expansion to increase API manufacturing capacity by 50%. With exceptional technical capabilities, the team supports custom small molecule development from clinical phases to commercial launch and scale-up.
Custom API Manufacturing FAQs
Custom API manufacturing is needed for pharmaceuticals that are considered challenging for one or more reasons. For example, they may involve highly toxic materials and need to be manufactured in a high-containment facility with specialized safety training. SK pharmteco has facilities that are designed to cater to many complex manufacturing requirements.
We always operate with standards front-of-mind, from the sourcing of raw materials to the quality control and validation of our manufacturing facilities. We have regulatory experts who understand the fundamentals and what additional steps need to be taken on a case-by-case basis.
API manufacturing requires more than specialized equipment and expertise. It requires a transparent working relationship and a CDMO partner that communicates proactively, keeping you briefed as important decisions need to be made. After many decades in this field, we understand this collaborative approach is the key to finding success in novel areas of API manufacturing.
This is another area where our decades of custom synthesis experience are invaluable. We know how the techniques work, how to maximize the technologies, and what our clients can expect in terms of scale and timeline. For example, our simulated moving bed (SMB) processes can be developed in a few weeks, with the potential to move from grams to multi-ton quantities in less than six months. Providing this information allows our clients to plan ahead based on the evolving needs of their pharmaceutical program.
We strive to provide an end-to-end solution, helping our partners achieve their overarching program goals. This includes supporting regulatory documentation and compliance, from the source materials to the finished API. We lean on our global experts to guide what is and isn’t needed, tailoring our approach based on the compound, your goals, and phase of development. This can be further customized based on regulatory agencies and programs, be it the U.S. FDA, EMA, or another regulatory agency. SK pharmteco is a true partner in this realm.
Contact us
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