What actions have pharmaceutical companies taken to deal with the risk of raw material supply?

[market analysis of chinapharma.com] on December 6, the State Administration of Market Supervision issued the news that "three manufacturers of glacial acetic acid API have been punished 12.83 million yuan for their monopolistic behaviors in accordance with the law", which severely cracked down on the monopolistic behaviors of API industry, and indicated that the supervision of API will be more and more strict in the future Now, at the end of the year, API sales are in the peak season What preparations or plans have API manufacturers made to maintain supply? (what actions have pharmaceutical companies taken to deal with the risk of raw material supply? Due to the strong demand for APIs, many manufacturers are busy with "the amount of money", or even unable to deliver goods in time In this context, some API enterprises have prepared sufficient supply in advance, and some pharmaceutical enterprises have made corresponding planning and handling methods for problems such as slow delivery of API in peak season For example, Hengyang Jinyi biotechnology recently announced that it summarized the effect of the specific implementation of the treatment measures on some problems such as slow delivery speed and long order scheduling cycle fed back by the cooperative customers of APIs in the previous period At the same time, after a period of overtime, all the customers' lists in the early stage have been sent out In addition, in view of the peak market season before the end of the year, the company is now ready to have sufficient supply in the warehouse If there are other arrangements, the company will issue a notice in time Due to the strict approval of API production in China, there are not many manufacturers with production qualification According to industry data, of the 1500 chemical APIs, only one enterprise has obtained the approval qualification to produce 50 APIs, only two enterprises can produce 44 APIs, and only three enterprises can produce 40 APIs This means that there may be only two or three qualified manufacturers of a certain API It can be seen that the number of API manufacturers is controlled by a small number of manufacturers Recently, some people said that a certain raw material was originally a supplier Later, considering the supply risk, they decided to add another one Under the circumstances, the industry reminds that according to the provisions of Article 142 of GMP, when the main factors affecting product quality, such as raw and auxiliary materials, packaging materials in direct contact with drugs, production equipment, production environment (or workshop), production process, inspection methods, etc., change, they shall be confirmed or verified When necessary, it shall also be approved by the drug regulatory department Therefore, the production of raw materials from new manufacturers needs to be re verified At the same time, it is necessary to carry out stability inspection, quality comparison and stability data analysis of the preparations produced from the new and old origin APIs Experts suggest: opening up the pharmaceutical market to the outside world some insiders said that at present, we should bid farewell to the shortage of drug supply at home Compared with the control thinking, perhaps market thinking is the fundamental solution Nowadays, with the continuous promotion of environmental protection and high pressure, many API manufacturers have stopped production because it is difficult to meet the standards, but the demand for API in China is more and more strong, and the market prospect of API in the future is very good In this context, many API products are only produced by two or three domestic enterprises Why not let foreign affordable API enter the domestic market and maintain the normal supply of domestic API? Some experts suggest that the monopoly enterprises should be resolute and destroy their monopoly position In addition, they should gradually open up the pharmaceutical market and introduce sufficient competition mechanism.