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API refers to any substance or mixture of substances used in the manufacture of medicines.
It is the upstream of the therapeutic medicine industry chain and the basis for ensuring the supply of medicines and meeting people's medication needs
.
China is a major producer and exporter of APIs.
In recent years, with the advancement of new medical reform policies and the influence of factors such as the transfer of global orders, the scale of China's API industry has continued to expand
.
At the same time, the export of raw materials of pharmaceutical companies to the sea is also accelerating
.
It is worth mentioning that, in order to expand the market share of foreign sales, a large number of enterprises are currently accelerating the submission of product access applications to relevant agencies in many countries, and many APIs have recently obtained CEP certificates
.
For example, recently, it was reported that the fluocinolone API produced by Tianjin Tianyao Pharmaceutical Co.
, Ltd.
has obtained the CEP certificate (European Pharmacopoeia Applicability Certificate), which is the first time that the API produced by a Chinese enterprise has obtained the CEP certificate
.
According to public information, CEP certification is an access certificate for the European market
.
CEP certification is not only recognized by all EU member states, but also recognized by countries that recognize the status of the European Pharmacopoeia
.
If the API used in the drug to be marketed has obtained a CEP, the marketing authorization application (MAA) can directly use the certificate, and the review authority will no longer evaluate the quality of the API
.
The industry believes that the acquisition of the CEP certificate by Tianyao shares will open the access channel for the product in the European market and other regulated markets that recognize the CEP certificate
.
It is worth mentioning that at present, in addition to fluocinolone API, many corticosteroid API products such as prednisone produced by Tianyao Co.
, Ltd.
have also passed the US FDA certification, and more than ten products have obtained CEP certificates
.
In the future, as more and more products are exported, Tianyao may usher in more opportunities in the sales of APIs.
In addition to Tianyao, Hanyu Pharmaceutical's octreotide APIs have also been issued by the European Medicines Quality Agency.
The CEP certificate is valid for five years from March 14, 2022
.
Octreotide is a synthetic octapeptide derivative of natural somatostatin, its pharmacological action is similar to that of somatostatin, but the effect lasts longer
.
It is understood that Hanyu Pharmaceutical has been insisting on entering the international market with APIs as a breakthrough for many years, and is committed to realizing the internationalization of preparations
.
In 2021, with the basic control of the epidemic, the demand for peptide APIs at home and abroad will gradually pick up
.
Under the national policy environment to encourage exports, Hanyu has accelerated the pace of exporting APIs
.
In line with the strategy of registration first, many products have been declared and registered abroad, and 9 varieties have completed the compliance certificate for export to the EU
.
It is expected in the industry that with the further promotion and implementation of the large-scale production of Hanyu Pharmaceutical, the export of peptide APIs will be more competitive, thereby further promoting the growth of API sales
.
In addition, Ningbo Minovar Pharmaceutical Co.
, Ltd.
has also recently received a CEP certificate for Losartan Potassium (API) issued by the European Agency for the Quality of Medicines
.
Losartan Potassium is a synthetic, potent orally active drug
.
Binding assays and pharmacological bioassays have demonstrated that it can selectively bind to AT1 receptors, and the EXP3174 metabolized in vivo has stronger activity and longer-lasting effects than the parent drug
.
The CEP application for losartan potassium (API) was obtained, and the CEP certificate was obtained on March 4, 2022.
Up to now, the company has invested about RMB 3.
12 million (unaudited) in this drug research and development project
.
Disclaimer : Under no circumstances shall the information or opinions expressed in this article constitute investment advice to anyone
.
It is the upstream of the therapeutic medicine industry chain and the basis for ensuring the supply of medicines and meeting people's medication needs
.
China is a major producer and exporter of APIs.
In recent years, with the advancement of new medical reform policies and the influence of factors such as the transfer of global orders, the scale of China's API industry has continued to expand
.
At the same time, the export of raw materials of pharmaceutical companies to the sea is also accelerating
.
It is worth mentioning that, in order to expand the market share of foreign sales, a large number of enterprises are currently accelerating the submission of product access applications to relevant agencies in many countries, and many APIs have recently obtained CEP certificates
.
For example, recently, it was reported that the fluocinolone API produced by Tianjin Tianyao Pharmaceutical Co.
, Ltd.
has obtained the CEP certificate (European Pharmacopoeia Applicability Certificate), which is the first time that the API produced by a Chinese enterprise has obtained the CEP certificate
.
According to public information, CEP certification is an access certificate for the European market
.
CEP certification is not only recognized by all EU member states, but also recognized by countries that recognize the status of the European Pharmacopoeia
.
If the API used in the drug to be marketed has obtained a CEP, the marketing authorization application (MAA) can directly use the certificate, and the review authority will no longer evaluate the quality of the API
.
The industry believes that the acquisition of the CEP certificate by Tianyao shares will open the access channel for the product in the European market and other regulated markets that recognize the CEP certificate
.
It is worth mentioning that at present, in addition to fluocinolone API, many corticosteroid API products such as prednisone produced by Tianyao Co.
, Ltd.
have also passed the US FDA certification, and more than ten products have obtained CEP certificates
.
In the future, as more and more products are exported, Tianyao may usher in more opportunities in the sales of APIs.
In addition to Tianyao, Hanyu Pharmaceutical's octreotide APIs have also been issued by the European Medicines Quality Agency.
The CEP certificate is valid for five years from March 14, 2022
.
Octreotide is a synthetic octapeptide derivative of natural somatostatin, its pharmacological action is similar to that of somatostatin, but the effect lasts longer
.
It is understood that Hanyu Pharmaceutical has been insisting on entering the international market with APIs as a breakthrough for many years, and is committed to realizing the internationalization of preparations
.
In 2021, with the basic control of the epidemic, the demand for peptide APIs at home and abroad will gradually pick up
.
Under the national policy environment to encourage exports, Hanyu has accelerated the pace of exporting APIs
.
In line with the strategy of registration first, many products have been declared and registered abroad, and 9 varieties have completed the compliance certificate for export to the EU
.
It is expected in the industry that with the further promotion and implementation of the large-scale production of Hanyu Pharmaceutical, the export of peptide APIs will be more competitive, thereby further promoting the growth of API sales
.
In addition, Ningbo Minovar Pharmaceutical Co.
, Ltd.
has also recently received a CEP certificate for Losartan Potassium (API) issued by the European Agency for the Quality of Medicines
.
Losartan Potassium is a synthetic, potent orally active drug
.
Binding assays and pharmacological bioassays have demonstrated that it can selectively bind to AT1 receptors, and the EXP3174 metabolized in vivo has stronger activity and longer-lasting effects than the parent drug
.
The CEP application for losartan potassium (API) was obtained, and the CEP certificate was obtained on March 4, 2022.
Up to now, the company has invested about RMB 3.
12 million (unaudited) in this drug research and development project
.
Disclaimer : Under no circumstances shall the information or opinions expressed in this article constitute investment advice to anyone
.
