The process began with the design and upgrade of the firm’s evaluation capabilities, which took one month. This gave Lotus the capabilities to detect and analyse the purity of the entaniopure drug R-Bambuterol.
Lotus then scaled-up from laboratory to pilot, which took 40 days, to ensure it had sufficient API and tablets for use in Phase I and II trials.
Production of the trial materials was performed in accordance with Chinese State Food and Drug Administration (SFDA) regulations. Lotus is aiming to launch the product in 2013 or 2014.