Custom API 
Manufacturing Services

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.