Europe is a huge drug consumption area, but also a major API import market in the world, and is an important target market
for many API manufacturers in China.
In recent years, domestic API enterprises are actively exploring the European market
.
Recently, Minova issued an announcement that the company received the European CEP certificate (European Pharmacopoeia Applicability Certificate)
for non-prednide (APIs) issued by the European Medicines Quality Agency (hereinafter referred to as "EDQM").
According to the announcement, fipronil (API) is one of Minova's key products, which is mainly used to repel fleas and dog lice
in dogs, cats.
In addition to Minova, since the beginning of this year, many pharmaceutical companies' API products have obtained CEP certificates
.
For example, Hanyu Pharmaceutical announced on November 16 that on November 15, the company's desmopressin acetate API received a CEP certificate
issued by the European Medicines Quality Agency.
Desmopressin acetate is a cyclic nonapeptide, a chemically synthesized vasopressor analogue that belongs to the vasoconstriction drugs
in vasoactive drugs.
Puli announced on November 22 that the company recently received the European Pharmacopoeia Applicability Certificate
for Glycopyrronium Bromide API issued by the European Medicines Quality Agency.
The drug is mainly suitable for gastric and duodenal ulcer, chronic gastritis, gastric acid secretion and other symptoms
.
Jinyao Pharmaceutical announced on October 26 that the company received the European Pharmacopoeia applicability certification certificate for isoleucine and leucine APIs issued by EDQM
.
Leucine can be used for amino acid metabolism disorders caused by chronic hepatic encephalopathy, cirrhosis, chronic active hepatitis and chronic persistent hepatitis
.
Isoleucine and leucine work with valine to promote normal body growth, repair tissues, regulate blood sugar, and provide needed energy
.
Yongtai Technology announced on October 31 that Zhejiang Yongtai Hand Palm Pharmaceutical Technology Co.
, Ltd.
, a subsidiary of the company, recently received the European Pharmacopoeia Adaptability Certificate of Gabapentin API issued by EDQM
.
Lunan Pharmaceutical announced on August 29 that the company received the European Pharmacopoeia Certificate
of Applicability of Zoledronic Acid API issued by the European Medicines Quality Agency.
It is reported that zoledronic acid does have a strong effect in the treatment of osteoporosis, not only suitable for patients with osteoporosis, but also suitable for patients
with mild calcium deficiency.
Sinopharm Hyundai announced in July that Jiangsu Wichida, a wholly-owned grandson company, received the CEP certificate
of abacavir sulfate API issued by the European Medicines Quality Agency.
The drug is mainly indicated for human immunodeficiency virus (HIV) infected adults with antiretroviral combination therapy
.
Hisun Pharmaceutical announced in May that the European Medicines Quality Agency decided to restore the company's six API European Pharmacopoeia applicability certification certificates
for doxorubicin hydrochloride (fermentation), doxorubicin hydrochloride, daunorubicin hydrochloride, epirubicin hydrochloride, mitomycin and bleomycin sulfate.
.
.
.
.
.
.
It is understood that the CEP certificate is a certificate
issued by EDQM to prove that the quality of APIs is strictly controlled in accordance with the methods described in the relevant monographs of the European Pharmacopoeia, and the quality of its products meets the standards of the European Pharmacopoeia.
Behind the successful acquisition of CEP certificate for related drugs of domestic pharmaceutical companies, it shows the recognition of the process and quality of the API in the European standard market, indicating that the drug can be sold in the European market and other regulated markets that recognize the CEP certificate, which will have a positive impact
on the company's further expansion of the international market.
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