Asymchem Inc, USA

OVERVIEW

Founded in North Carolina in 1995, today recognized across the globe for proprietary technology development in the pharmaceutical industry.

• cGMP certified and US FDA registered site with No 483.
• Compliance with all ICH guidelines Q7/ Q8/ Q9/ Q10/ Q11, US/ EU regulations.
• Proprietary manufacturing process development, which does not infringe any patents.
• Full technical and regulatory documentation support, for filling across the globe.
• Detailed MOA, manufacturing process Flow chart and Stability data available.
• Working standards, Reference standards and Markers can be made available upon request.
• Product conformity to customer specification and regulatory requirements through process control & achievement.
• Documentation management system, manage through “Change control and Quality manual”
• Dedicated advanced characterization & control of the product.Best In class Impurity profiling throughout the shelf life.
• Best in class Impurity Profiling throughout the shelf life.