APIs are active pharmaceutical ingredients that directly exert pharmacological effects on the human body and are the basic substances
that constitute the pharmacological effects of drugs.
China is a major API production and exporter, in recent years, with the transfer of overseas pharmaceutical R&D and production outsourcing industry and the burst of innovation demand in China's pharmaceutical industry, it is expected that China's API industry will welcome good development opportunities
.
Recently, there has been continuous news about the approval of domestic API products, involving Xinhua Pharmaceutical, Northeast Pharmaceutical, Tuoxin Pharmaceutical, Sinopharm Modern and other API enterprises
.
On October 18, Tuoxin Pharmaceutical issued an announcement that Xinxiang Pharmaceutical, a wholly-owned subsidiary, received the "Notice of Approval of Marketing Application for Chemical APIs"
issued by the State Food and Drug Administration.
Cyclophosphoadenosine is a vasodilator used for angina pectoris, myocardial infarction, myocarditis and cardiogenic shock
.
It has a certain effect
on improving the symptoms of rheumatic heart disease, such as palpitations, shortness of breath, and chest tightness.
Combined with chemotherapy for acute leukemia can improve the efficacy, can also be used for the induction of acute leukemia remission, in addition, it also has a certain effect
on elderly chronic bronchitis, various hepatitis and psoriasis.
On the same day, Sinopharm Modern issued an announcement that Sinopharm Jiangsu Wichida API Dapoxetine Hydrochloride received the "Chemical API Marketing Application Approval Notice"
issued by the State Food and Drug Administration.
Dapooxetine hydrochloride is a selective serotonin reuptake inhibitor that is primarily indicated for on-demand treatment
of premature ejaculation (PE) in men aged 18 to 64 years.
At present, other domestic manufacturers of the API include Jiangsu Haici, Northeast Pharmaceutical, Lianhuan Pharmaceutical, etc
.
Xinhua Pharmaceutical recently announced that the company received the "Notice of Approval of Marketing Application for Chemical APIs" approved and issued by the State Food and Drug Administration, and the company's research and development of sevelamer carbonate API was approved for marketing
.
According to reports, sevelamer carbonate is a polymer drug, and its polymerization crosslinking reaction process is difficult to control, and the quality control standards are high
.
At present, the CDE raw and auxiliary package registration information disclosure platform shows that Xinhua Pharmaceutical is the second approved enterprise
.
This product preparation is mainly used to reduce the content of serum inorganic phosphorus in patients with chronic kidney disease who need dialysis, and the use is oral.
Northeast Pharmaceutical recently reported that the company's acetyl-levocarnitine hydrochloride API has been approved by the Drug Review Center of the State Medical Products Administration, and has received the "Chemical API Marketing Application Approval Notice"
approved and issued by the State Medical Products Administration.
It is reported that acetyl-L-carnitine hydrochloride is a neurological drug, mainly used to relieve paresthesias
caused by diabetic peripheral neuropathy.
The approval of the marketing application for this product will provide further support
for the continued development of the company's L-carnitine family of products.
Northeast Pharmaceutical is also the second API manufacturer in China to pass the review and approval
.
Hokuriku Pharmaceutical announced on September 29 that recently, the company's repaglinide API 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
.
In addition, APIs such as Osaicon's nelatinib maleate API and Nifedipine API of Lifang Pharmaceutical have recently been approved
.
Behind the increase in the layout of many pharmaceutical companies, it can be seen that the market space of APIs is being optimistic
.
According to a report from Mordor Intelligence, the global API market size was about $174.
96 billion in 2020 and is expected to reach $245.
88 billion by 2026, with a projected compound annual growth rate of 5.
84%
from 2021 to 2026.
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