2013 can be called as the most confusing and depressing year for the API (Active Pharmaceutical Ingredients) industry: the export of API being no longer successful, the amount of export continuously decreased with the decrease extent being widened. However, the new dawn in 2014 gradually appears: the characteristic API perhaps will become one hot spot of the industry due to the R&D boom of the innovative drugs in recent years.
The export data of characteristic API being obviously increased
Viewed from the export situation of part characteristic API ranking top ten of the amount of exports of 2013 and compared with the same period last year, the amount of exports appears with five increases and five decreases: it is worth noting that the increasing rate of amount of exports of five characteristic API is far greater than the decreasing rate of other characteristic API. For example, the amount of export of irbesartan is USD112.27 million, the growth rate being 79.30%; the amount of export of meropenem is USD57 million, the growth rate being 140.76%; the amount of export of spironolactone is USD54.74 million, the growth rate being 22.74%.
The characteristic API being extremely popular in 2014 and the initiatives for international certification of the enterprises being strong
The awareness of Chinese enterprises for international certification has become stronger. Totally 151 items of API main documents category II (DMF) were submitted to the U.S. FDA by the drug enterprises of our country before the end of November in 2013, accounting for 12.5% of the total items. Totally 504 API items of the EU EDQM certificate were passed by Chinese API enterprises and there had been 60 API of 44 units acquiring EDQM API certificate in 2013, which was the year with the largest number of acquiring this certificate in recent years.