Enhua pharmaceutical heavy new drug Remifentanil Hydrochloride for Injection approval completed

According to the information on the website of CFDA on October 13, the review status of remifentanil hydrochloride for injection, a heavy new drug of Enhua Pharmaceutical Co., Ltd., was changed to "approved - to be certified" The company said the approved production of remifentanil was not a big problem He pointed out that the company's existing plant can be used for product production, and remifentanil belongs to class I narcotic drugs, which can be sold without bidding, and it is expected that the product will be on the market within the year But he also admitted that this year's sales contribution to the product is not expected to be high Remifentanil is mainly used in general anesthesia induction and maintenance analgesia Its analgesic effect is similar to that of fentanyl, and it has little side effect on respiratory inhibition, so it has substitution effect on fentanyl CFDA website information shows that at present, only humanwell pharmaceutical and Sinopharm group have the approval documents of the drug in China, of which humanwell pharmaceutical products account for the vast majority of the market share The above-mentioned company personnel have pointed out that the company has made channel preparation for the listing of remifentanil through the sales of fentanyl in the early stage, and the product price of remifentanil after the listing will be similar to that of humanwell pharmaceutical Enhua Pharmaceutical Co., Ltd is the leading drug manufacturer in the field of central nervous system in China Remifentanil is one of the heavyweight anesthetic products reserved by the company It is a high probability event that the company expects remifentanil to grow into more than 100 million varieties In the first half of 2014, the total operating revenue of narcotic drugs of Enhua pharmaceutical industry reached 285 million Remifentanil is an ultra short acting opioid receptor agonist, which has the characteristics of rapid onset after injection, no accumulation after long-term infusion, and fast recovery after drug withdrawal It is commonly used in anesthesia induction and maintenance, local anesthesia assisted sedation and analgesia, and is a very ideal anesthesia and analgesic drug in surgery Due to the addictive nature of the product, its production and sales are strictly controlled by the state (no more than 2 manufacturers of API and no more than 3 manufacturers of preparations are required) After the approval of the product, the company will become the third approved enterprise after humanwell medicine and Langfang national medicine, and the market will be shared by these three enterprises in the future The approval of this product is also conducive to further enhancing the synergy of the company's series products Remifentanil is still in a good growth period, with broad potential According to the statistical data, in 2013, the amount of remifentanil used in sample hospitals was about 194 million yuan, and the overall market scale was expected to be about 600 million yuan, maintaining a rapid growth rate of about 25% From the comparison between the sample hospitals of this variety and the overall market scale, it can be seen that the remifentanil market is still concentrated in the middle and high-end hospitals, and there is still much room for growth in the future.