A number of local API companies pass Jiayin, which is related to the approval of products and the construction of production capacity

【Pharmaceutical network industry dynamics】China is one of the world's major API producers and exporters, in recent years, with the increasing variety and quantity of generic drugs, the increase in environmental protection cost pressure, and the improvement of China's API production enterprises in terms of process technology, production quality and other aspects of the ability, overseas API enterprises to accelerate the transfer to China, China's API industry production scale continues to expand, which also attracted many domestic API enterprises to increase the layout
.
Recently, many local API companies have passed on Jiayin, and there has been new progress in the approval of the company's API products and
the construction of production capacity.
A number of API products have been approved Xinhua Pharmaceutical recently announced that the company received the "Notice of Approval of Chemical API Listing Application" issued by the State Food and Drug Administration, and the carbonate Siviram API developed by the company was approved for listing
.
According to reports, the carbonate Sviram is a polymer drug, and its polymerization crosslinking reaction process control is difficult, and the quality control standard is high
.
Statistics show that the global sales of carbonate Sveram preparations in 2020 are 777 million US dollars, and the consumption of APIs is about 548 tons, and the market prospect is broad
.
The approval of Xinhua Pharmaceutical's API means that it will have strong competitiveness
in the market.
Liaoning Fangda Group Northeast Pharmaceutical recently news, the company's acetyl-hydrochloride levocnitin API passed the State Drug Administration's drug review center approval, and received the State Drug Administration approved the "Chemical API Marketing Application Approval Notice"
.
It is reported that acetyllevonectin hydrochloride is a drug for the nervous system, mainly used to alleviate paresthesias
caused by diabetic peripheral neuropathy.
The approval of the listing application for this product will provide additional support
for the continued development of the company's Levocarnitine range of products.
Northeast Pharmaceutical is also the second API manufacturer in China to pass the review and approval
.
Hokuriku Pharmaceutical announced on the evening of September 29 that recently, the company's repaglinide API received the "Notice of Approval of Chemical API Listing Application"
issued by the State Food and Drug Administration.
Repaglinade API can be used to produce repaglinide tablets
.
Repaglinide tablets are short-acting insulin secretagogues; Can fully control postprandial and fasting blood glucose, single drug or combined metformin has an ideal hypoglycemic effect; Has a good cardiovascular protective effect
.
Xinhua Pharmaceutical also announced on the evening of the 29th that recently, the company received the State Food and Drug Administration's approval of the carbonate Sviram "Notice of Approval of Chemical API Listing Application", and currently shows on the CDE raw and auxiliary package registration information publicity platform that Xinhua Pharmaceutical is the second approved enterprise
.
The preparation of this product is mainly used to reduce the content of serum inorganic phosphorus in patients with chronic kidney disease who require dialysis, and is used orally
.
Pharmaceutical companies actively promote the construction of production capacity Although the prospect of the API market is still optimistic in the industry, production capacity is a bottleneck problem
in front of some enterprises.
On September 29, Jingxin Pharmaceutical said in a survey that the sales revenue of the company's API sector in the first half of 2022 increased compared with last year, but it was not as fast as the growth rate of the preparation business, mainly because the existing API production capacity was close to the limit
.
In order to lay out the API sector, many companies have been actively promoting the construction of
production capacity since this year.
Jingxin Pharmaceutical mentioned that the newly built API base in Weifang, Shandong Province, is under construction as planned, and it is expected that some production facilities can be trial-produced next year, which will alleviate the bottleneck of the company's API production capacity and further optimize the layout
of the company's API plate.
On October 6, Jincheng Pharmaceutical also said on the investor interactive platform that the proestlene API production line is in the process of construction, and it is expected to be completed by the end of 2022 and trial production
in the first quarter of 2023.
Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.