Focusing on APIs, how can enterprises not "capsize"?

[trends of pharmaceutical network industry] in recent years, due to the impact of environmental protection policies, the API industry has survived the fittest A number of small and medium-sized enterprises without transformation qualification and weak capital and technology have been forced out of the market In order to survive, the remaining enterprises have to carry out transformation and upgrading in environmental protection as required, or even establish new factories On October 15, 2019, the measures for the supervision and administration of drug production (Draft for comments) were published, among which the new content of the entrusted production management in Article 43 is "generally, the entrusted production of APIs is not allowed" Industry sources said there were two guesses about the rule One is to remove this content in the subsequent documents The API can still be commissioned according to the preparation MAH system On the other hand, considering the long production cycle of API, different operation processes, strong process variability, diverse production equipment, high quality risk in production process and high risk of safety and environmental protection, the holder of API must be the manufacturer itself At present, it is believed that due to environmental protection and other factors, the transformation cost of API enterprises will be relatively high, and the cost of large-scale production of API will be lower than that of small-scale decentralized production Preparation enterprises need to balance the cost risk, quality risk and supply risk of APIs according to their own needs, and make corresponding decisions Considering the current domestic situation, API enterprises may make the following choices First, the API production enterprises directly controlled by pharmaceutical enterprises are mainly self-sufficient, not for profit Such pharmaceutical enterprises generally have their own heavy-duty products, and the market share of the products is relatively large The industry believes that the API production base of such preparation enterprises can not only meet the API supply demand of their own products, but also be used for the registration and application of new products, or to undertake the API varieties of other enterprises That is to say, we should take stability as the main strategy, follow our own preparation varieties, and strive for progress in stability Second, the API manufacturing enterprises that have mutual customer relationship with pharmaceutical enterprises This kind of API enterprises are relatively independent, with independent R & D capacity of new domestic varieties, no problems in continuous investment in R & D, and professional registration and application team, even with international registration capacity Some API enterprises also have rich API production lines, stable supply channels, and enough capacity to supply new products online The industry believes that this kind of API production enterprises have a broad prospect, and need to rely on its advantages and strength to continuously expand market share and become more and more stable in the market Some experts pointed out that with the intensification of pharmaceutical regulatory policies and the continuous development of API industry, it is expected that the API industry will usher in a golden development period in the next 5-10 years For this kind of API enterprises, the next 5-10 years will also be a golden period of development Third, although it is an independent API manufacturer with production capacity, it lacks independent R & D capacity According to the needs of pharmaceutical customers, the pharmaceutical enterprises can undertake the R & D work, undertake the production of API varieties, and standardize the interest distribution of both parties through commercial contracts The industry believes that such enterprises lack independent R & D capability, and generally the preparation enterprises undertake the R & D work, and do not need to invest too much R & D cost in the short term In addition, there are also views that, driven by the volume purchase policy, the cost of new API plants is relatively high, and large enterprises with capital capacity can be deployed, but it may not be realistic for small and medium-sized pharmaceutical enterprises In the future, the API industry will develop in the direction of specialization and scale, and the leading enterprises will have advantages.