The drug registration certificate is the "quasi-birth certificate" of the drug, and for pharmaceutical companies, only by obtaining the product drug registration certificate can they obtain the qualification to produce the product and can circulate
in the market.
Since 2023, a large number of pharmaceutical companies have obtained drug registration certificates for their products
.
For example, in the past week, Hengrui Pharmaceutical, Nord Pharmaceutical, Huaren Pharmaceutical and other enterprises have received good news
.
Cyclophosphamide capsules
On January 15, Hengrui Pharmaceutical announced that the company recently received the "Drug Registration Certificate"
for cyclophosphamide capsules approved and issued by the State Medical Products Administration.
The approved indication is "suitable for adults and children 6 years of age and older for the treatment of malignant lymphoma (Ann Arbor stage III and IV), Hodgkin lymphoma, lymphocytic lymphoma (nodular or diffuse), mixed cell lymphoma, histiocytic lymphoma, Burkitt lymphoma, etc
.
" Up to now, Hengrui Pharmaceutical's cyclophosphamide capsule-related projects have invested a total of about 7.
91 million yuan in R&D expenses.
It is understood that cyclophosphamide is involved in the cross-linking of tumor cell DNA, mainly through the mixed functional microsomal oxidase system in the liver bioconversion to active alkylated metabolites
.
According to the data, the global sales of cyclophosphamide-related dosage forms in 2021 were about $325 million
.
Losartan potassium tablets
On January 13, Tianyu announced that Nord Pharmaceutical, a wholly-owned subsidiary of the company, recently received the "Drug Registration Certificate"
for losartan potassium tablets (50mg, 100mg) approved and issued by the State Food and Drug Administration.
Losartan potassium tablets are used to treat essential hypertension, and Nord Pharmaceutical's losartan potassium tablets 50mg and 100mg specifications were accepted
by the State Food and Drug Administration in September 2021.
At present, the cumulative investment expenses of the company and its subsidiaries are about 11.
7877 million yuan
.
As of the announcement date, in addition to Nuode Pharmaceutical, domestic manufacturers of this preparation include Zhejiang Huahai Pharmaceutical Co.
, Ltd.
and China Resources Shuanghe Pharmaceutical Co.
, Ltd.
and other 8 enterprises
.
Sodium bicarbonate Ringer injection
News on January 13, Huaren Pharmaceutical said that it recently received the "Drug Registration Certificate" of "sodium bicarbonate Ringer injection"
approved and issued by the National Medical Products Administration.
Sodium bicarbonate Ringer injection is a compound preparation composed of a variety of electrolytes (containing sodium, potassium, magnesium, calcium ions), which is suitable for supplementing, correcting extracellular fluid and correcting metabolic acidosis
when the circulating blood volume and interstitial fluid are reduced.
Huaren Pharmaceutical's sodium bicarbonate Ringer injection that obtained the registration certificate this time is deemed to have passed the consistency evaluation
of the quality and efficacy of generic drugs.
Sodium bicarbonate Ringer injection was originally researched by Otsuka Pharmaceutical, which was approved in Japan in 2008 and launched
in Japan in 2010.
At present, a total of 6 domestic enterprises (including Huaren Pharmaceutical) have obtained the registration certificate of sodium bicarbonate Ringer injection (data source: National Medical Products Administration website).
According to statistics, in 2021, the sales of sodium bicarbonate Ringer injection in China's urban public hospitals was 338.
45 million yuan
.
Esomeprazole magnesium enteric-coated dry suspension
Jianfeng Group issued an announcement that Erying Company, a holding subsidiary of Jianfeng Pharmaceutical, a holding subsidiary of the company, has received the "Drug Registration Certificate"
of Esiomera magnesium enteric-coated dry suspension approved and issued by the State Medical Products Administration.
Esomeprazole magnesium enteric-coated dry suspension is a population-specific dosage form introduced by AstraZeneca after tablets and capsules for all patients
who are unable or simply unwilling to swallow capsules or tablets.
The approval marks that Jianfeng Pharmaceutical and its subsidiary Erying Company have the qualification to produce and sell the drug, which will further enrich the product line of Jianfeng Pharmaceutical and help enhance the competitiveness
of the company's pharmaceutical business.
Up to now, the R&D investment of the enteric-coated dry suspension project of esomeprazole magnesium of Erying Company is about 15.
7805 million yuan
.
Felodipine sustained-release tablets
On January 11, Huahai Pharmaceutical announced that the company recently received the "Drug Registration Certificate"
of felodipine sustained-release tablets approved and issued by the State Medical Products Administration.
Felodipine sustained-release tablets obtained the "Drug Registration Certificate" of the State Food and Drug Administration, which will further enrich Huahai Pharmaceutical's product line and help enhance the market competitiveness
of the company's products.
It is worth mentioning that since the production of felodipine sustained-release tablets approved according to Class 4 chemicals can be regarded as passing the consistency evaluation, medical institutions will give priority to procurement and clinical selection, which may have a positive impact
on their business performance.
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