Flexible Solutions for API Manufacturing Challenges
At times, due to various factors, it may not be feasible for us to manufacture your active pharmaceutical ingredient (API) directly. However, rest assured, we have a solution in place. In such instances, if alternative options are unavailable, we can outsource the API from a reputable company, even if they lack GMP certification.
Subsequently, we will meticulously purify the API within our state-of-the-art facility, adhering strictly to GMP conditions.
Moreover, we go the extra mile by providing transparency and comprehensive documentation. As part of our commitment to quality assurance, we will elaborate on the Active Substance Master File (ASMF) by including detailed insights into the manufacturing process from the original manufacturer. Additionally, we will take charge of registering the API in the target countries to ensure compliance with regulatory standards.
Rest assured, your satisfaction and the safety of the end product remain our top priorities. With our expertise and dedication to excellence, you can trust us to deliver nothing short of exceptional results, even in challenging situations. Let’s navigate this journey together towards achieving success and fulfilling your pharmaceutical needs seamlessly.