On the same day, two domestic pharmaceutical companies announced that their API products had received CEP certificates

【Pharmaceutical Network Industry News】On the evening of October 31, Yongtai Technology and Sirnaomics 2 domestic pharmaceutical companies reported good news that the company's API products recently obtained the European Pharmacopoeia Adaptability Certification Certificate (referred to as "CEP Certificate")
issued by the European Agency for the Quality of Pharmaceutical Products.
Sirnaomics announced that its wholly-owned subsidiary, Chengdu Sirnaomics Biopharmaceutical Co.
, Ltd.
, recently obtained the CEP certificate
for octreotide acetate API issued by the European Agency for the Quality of Medicines Agency.
According to the announcement, 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 sclerotherapy therapy); Prevention of complications after pancreatic surgery; Relieves signs and symptoms 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 US DMF record and domestic production approval
.
Octreotide acetate is mainly used in foreign countries for the treatment of acromegaly and inhibition of neuroendocrine tumors, and is mainly used as hemostasis in the digestive tract in China
.
For the CEP certificate obtained by Octreotide acetate APIs, the company believes that it shows the recognition and affirmation of the quality of the company's Octreotide acetate APIs in the European normative market, marking that the API can be sold in the European market and other standardized markets that recognize CEP certificates, which will have a positive impact
on the company's further expansion of the international market.
On the same day, Yongtai Technology announced that Zhejiang Yongtai Palm Pharmaceutical Technology Co.
, Ltd.
, a subsidiary of the company, recently received the CEP certificate
of gabapentin API issued by the European Agency for the Quality of Drugs.
According to reports, gabapentin is a synthetic amino acid, similar
to the neurotransmitter γ-aminobutyric acid (GABA).
The indications are: 1.
Postherpetic neuralgia: for the treatment of postherpetic neuralgia in adults; 2.
Epilepsy: for adults and children over 12 years old with or without secondary systemic seizures for partial seizures
.
It can also be used for the adjuvant treatment
of partial seizures in children aged 3~12 years.
According to data from Intranet, the sales of gabapentin terminals in China's public medical institutions in 2019 were 215 million yuan, a year-on-year increase of 5.
77%.

Yongtai Technology said that the company's gabapentin API products obtained CEP certificate, indicating that the API meets the quality requirements of the European Pharmacopoeia, showing the recognition and affirmation of the quality of the API in the European standard market, marking that the API can be sold in the European market and other standardized markets that recognize CEP certificate, which will have a certain impact on
the company's expansion of the international market and the improvement of the company's business performance 。 China is a large API production and export country, with the continuous expansion of the pharmaceutical market, API as the basic raw materials for drug production, the market scale is also rising year by year, especially in recent years, the number of original drug varieties with patent expiration continues to increase, the number of generic drug varieties increases rapidly, the corresponding API demand also continues to grow, it is expected that the global API industry market size will maintain stable growth, according to the forecast of Markets and Markets, The global API market size will grow
at a CAGR of 6.
1% from 2019 to 2024.
The industry believes that the development trend of China's API industry will continue to improve
in the future.
Recently, in addition to Yongtai Technology and Sirnaomics, there are also many pharmaceutical companies with good news that related API products have been approved in China, including Zhongsheng Pharmaceutical's bromofenac sodium API, Hanyu Pharmaceutical's Wuhan company's API "Atoxiban acetate", Xinhua Pharmaceutical's chemical API prednisolone, Tuoxin Pharmaceutical's cyclophosphoadenosine API, Sinopharm Hyundai's API dapoxetine hydrochloride and so on have been approved for marketing
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice
to anyone.