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The reporter learned from Tianjin Tianyao Pharmaceutical Co.
, Ltd.
on the 24th that the fluocinolone API produced by the company has obtained the CEP certificate (European Pharmacopoeia Applicability Certification), which is the first time that the API produced by a Chinese company has obtained the CEP certificate
.
It is understood that 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
.
At present, the market space for fluocinolone is broad
.
According to the IQVIA database, the global market sales of fluocinolone preparations in 2020 will be US$397 million; in 2021, the global market sales of fluocinolone preparations will be US$409 million
.
The CEP certificate for fluocinolone APIs for the first time by a Chinese company has opened the access channel for this product in the European market and other regulated markets that recognize the CEP certificate
.
Previously, many corticosteroid API products such as prednisone produced by Tianyao Co.
, Ltd.
have passed the US FDA certification, and more than ten products have obtained CEP certificates
.
(Finish)
, Ltd.
on the 24th that the fluocinolone API produced by the company has obtained the CEP certificate (European Pharmacopoeia Applicability Certification), which is the first time that the API produced by a Chinese company has obtained the CEP certificate
.
It is understood that 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
.
At present, the market space for fluocinolone is broad
.
According to the IQVIA database, the global market sales of fluocinolone preparations in 2020 will be US$397 million; in 2021, the global market sales of fluocinolone preparations will be US$409 million
.
The CEP certificate for fluocinolone APIs for the first time by a Chinese company has opened the access channel for this product in the European market and other regulated markets that recognize the CEP certificate
.
Previously, many corticosteroid API products such as prednisone produced by Tianyao Co.
, Ltd.
have passed the US FDA certification, and more than ten products have obtained CEP certificates
.
(Finish)
