Quality

Regulatory Affairs

Our facility has been set up to carry out fermentations of multiple scales and a wide variety of isolation techniques for recovery of secondary metabolites from fermentation broths, while ensuring a high degree of compliance in quality and operations meeting international regulatory requirements. We have regulatory submissions (Drug Master Files) in all major regulatory jurisdictions and have undergone regulatory agency inspection resulting in approvals being granted to our customers for use of materials manufactured at our site in their formulations.