As a major producer and exporter of APIs, with the promotion of new policies for medical reform and the impact of global order transfer and other factors in recent years, the scale of China's API industry is expanding while the overseas expansion of APIs is also accelerating
.
Recently, news about the approval of domestic API products overseas has been coming
.
ON NOVEMBER 11, HANYU PHARMACEUTICAL ANNOUNCED THAT GANIREC ACETATE API DF RECEIVED NO FURTHER COMMENTS LETTER
ISSUED BY THE US FOOD AND DRUG ADMINISTRATION (FDA).
According to FDA's review process for APIs, the issuance of the letter means that the API is approved
.
Garnirex acetate, a chemically similar decapeptide compound to endogenous gonadotropin releasing hormone (GnRH), is an antagonist of GnRH and competitively inhibits GnRH binding to GnRH receptors, thereby rapidly and reversibly inhibiting gonadotropin (luteinizing hormone LH and follicle-stimulating hormone FSH) secretion
.
Garnirex acetate is mainly used in assisted reproductive technology, and its main role is to prevent early ovulation and also reduce or prevent the occurrence
of ovarian hyperstimulation syndrome.
On October 31, Sirnaomics announced that its wholly-owned subsidiary, Chengdu Sirnaomics Biopharmaceutical Co.
, Ltd.
, recently obtained the CEP certificate
of octreotide acetate API issued by the European Medicines Quality Agency.
Octreotide acetate preparation products are mainly used for the emergency treatment of esophageal-gastric variceal bleeding caused by liver cirrhosis, and are combined with special treatments (such as endoscopic sclerosing therapy); Prevention of postoperative complications of the pancreas; Relieves symptoms and signs associated with gastrointestinal endocrine tumors, etc
.
The original research enterprise of the product is Novartis of Switzerland, and the company's octreotide acetate API has obtained the DMF filing and domestic production approval in the United States
.
It is understood that octreotide acetate is mainly used in foreign countries for the treatment of acromegaly and inhibition of neuroendocrine tumors, and is mainly used as digestive tract hemostasis
in China.
The receipt of CEP certificate marks that the API can be sold in the European market and other regulated markets that recognize the CEP certificate, or will have a positive impact
on Sirnaomics' further expansion into the international market.
On October 26, Jinpharm Pharmaceutical issued an announcement that isoleucine and leucine APIs received the European Pharmacopoeia Applicability Certificate (hereinafter referred to as "CEP Certificate") issued by the European Medicines Quality Agency (hereinafter referred to as "EDQM"
).
Isoleucine and leucine work with valine to promote normal body growth, repair tissues, regulate blood sugar, and provide needed energy
.
Up to now, the cumulative investment cost of Jinyao Pharmaceutical to obtain the CEP certificate of isoleucine and leucine APIs is about 1.
4 million yuan
.
.
.
.
.
.
.
From the current point of view, a large number of API pharmaceutical companies are accelerating their products to the sea, and it is expected that many pharmaceutical companies will usher in new opportunities
in API sales in the future.
However, at the same time, the industry believes that in order to better meet the quality and output requirements of overseas customers for APIs, API companies will also be forced to accelerate transformation and upgrading and develop
in the direction of higher quality.
={"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:","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)]; 
