API refers to any substance or mixture of substances used in drug manufacturing, which is the upstream of the therapeutic drug industry chain and the basis for
ensuring drug supply and meeting people's drug needs.
Recently, many pharmaceutical companies have announced that the registration and marketing applications of APIs have been approved
.
On October 12, Aosaikang announced that Nanjing Hairun Pharmaceutical Co.
, Ltd.
, a wholly-owned subsidiary of the company, recently received the "Notice of Acceptance"
for the marketing registration of nelatinib maleate APIs issued by the State Medical Products Administration.
Nelatinib maleate is developed by Pfizer in the United States and licensed to Puma in 2011 as an epidermal growth factor receptor tyrosine kinase inhibitor
.
In April 2020, the State Food and Drug Administration approved the import and marketing of nelatinib maleate tablets, the trade name is He Li'an, the specification is 40mg, suitable for human epidermal growth factor receptor 2 (Her2)-positive adult patients with early breast cancer, after receiving trastuzumab-containing adjuvant therapy for intensive adjuvant therapy, there are no other similar products
in China.
Aosaikang disclosed that it submitted the registration and filing of the API of inertinib maleate in September 2022, and recently obtained the "Notice of Acceptance" for the marketing registration of APIs, which will lay the foundation for the development of the company's nelatinib maleate preparations, enrich the company's product layout in the field of breast cancer, and enhance market competitiveness
.
On October 11, Lifang Pharmaceutical announced that the company recently received the "Acceptance Notice"
for the marketing registration application of nifedipine API issued by the State Medical Products Administration.
Nifedipine is a dihydropyridine calcium ion antagonist, and its preparation is mainly used clinically for the treatment of hypertension, coronary heart disease, chronic stable angina (exertional angina), etc
.
The application for marketing registration of nifedipine API was accepted, indicating that the variety has entered the registration review stage
.
If the registration review is successfully passed, it will further enrich the pipeline of Cube Pharmaceutical's API products and increase the competitiveness
of preparation varieties.
On September 29, Hokuriku Pharmaceutical announced that the company's repaglinide API recently received the "Chemical API Marketing Application Approval Notice"
approved and issued by the State Food and Drug Administration.
Repaglitinide APIs can be used to produce repaglinide tablets
.
Repaglitinide tablets are short-acting insulin secretagogues; It can fully control postprandial and fasting blood sugar, and has an ideal hypoglycemic effect as a single agent or in combination with metformin; Has a good cardiovascular protective effect
.
On the same day, Xinhua Pharmaceutical said that it had received the "Notice of Approval of Marketing Application for Chemical APIs" approved and issued by the State Medical Products Administration, and its research and development of sevelamer carbonate API was approved for marketing
.
It is reported that sevelamer carbonate is clinically used to reduce the content of serum inorganic phosphorus caused by dialysis in patients with chronic kidney disease, and the efficacy is certain, and the incidence of hypercalcemia is significantly reduced
compared with traditional phosphorus binders.
Statistics show that the global sales of sevelamer carbonate preparation in 2020 reached 777 million US dollars, consuming about 548 tons of APIs, and the market prospects are broad
.
At present, on the CDE original and auxiliary package registration information publicity platform, Xinhua Pharmaceutical is the second approved enterprise
.
From the perspective of a large number of pharmaceutical companies promoting more API products to market, the API market is widely optimistic
in the industry.
The industry expects that as far as the domestic API market is concerned, with the normalization of centralized procurement, consistency evaluation and drug-related approval and other policies, the industry concentration continues to increase, and the transfer of beneficial orders, the status of the API industry in the industrial chain will continue to improve, and more pharmaceutical companies will increase their layout
in this field in the future.
={"common":{"bdSnsKey":{},"bdText":"","bdMini":"1","bdMiniList":false,"bdPic":"","bdStyle":"0","bdSize":"32"},"share":{},"image":{"viewList":[" weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"],"viewText":"Share to:","viewSize":"24"},"selectShare":{" bdContainerClass":null,"bdSelectMiniList":["weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"]}}; with(document)0[(getElementsByTagName('head')[0]|| body).
appendChild(createElement('script')).
src='http://bdimg.
share.
baidu.
com/static/api/js/share.
js?v=89860593.
js?cdnversion='+~(-new Date()/36e5)]; 
