9 drugs have passed the consistency evaluation. Yangtze River, Haizheng, Haosen, Shanghai Pharmaceutical...
â–Zhejiang Haizheng: rosuvastatin calcium tablets, through consistency evaluation
On July 24th, Zhejiang Hisun Pharmaceutical released the “Announcement on the Consistency Evaluation of Rosuvastatin Calcium Tablets through Generic Drugsâ€. It said that it has received the "Approval of Drug Replenishment Application" issued by the State Food and Drug Administration for rosuvastatin calcium tablets, which is evaluated by the consistency of the quality and efficacy of generic drugs.
According to the announcement, Haizheng Pfizer Pharmaceutical Co., Ltd. (now renamed as: Huihui Pharmaceutical Co., Ltd.) is the marketing license holder of this product, and Haizheng Pharmaceutical Co., Ltd. as a manufacturing enterprise.
Up to now, there have been two pharmaceutical companies with rosuvastatin calcium tablets, through the consistency evaluation, respectively, Zhejiang Jingxin and Zhejiang Haizheng. Zhejiang Jingxin passed the date of February 14, 2018.
Since December 29, 2017, the former State Food and Drug Administration has released the first batch of drugs that have passed the consistency evaluation, and there are more than 50 products that stand out. In July, nine drugs passed smoothly.
â–æµ·Cisco: flupirtine to melilizine tablets
On July 19th, Hai Cisco issued an announcement that the generic drug product “Flupiride Till Melistrol Tablets†developed by the company received a notification of conformity evaluation and received the trademark name “Le Pan®â€. Mainly used for mild/moderate depression and anxiety, neurasthenia, psychogenic depression, depressive neurosis and other symptoms.
The original developer of this variety was the flupirtine militazine tablets of Lingbei Pharmaceutical of Denmark, which was first listed in Austria in 1971.
â–ä¹æ™®åŒ»ç–—: atorvastatin calcium tablets
On July 18th, Lepu (Beijing) Medical announced that its holding subsidiary, Zhejiang Xindonggang Pharmaceutical, received the “Approval of Pharmaceutical Supplement†for “Atorvastatin Calcium Tablets†on July 17. Both the 20mg and 10mg specifications passed the evaluation of the consistency of the quality and efficacy of the generic drug.
Atorvastatin calcium tablets are the largest drug in the field of cardiovascular disease treatment, with a domestic market capacity of nearly 16 billion. At present, there are 6 companies in the market that compete for nearly 16 billion market capacity. The original research market share of Pfizer Lipitor is nearly 60%, and the market is highly concentrated and monopolized.
Up to now, atorvastatin calcium tablets from Beijing Jialin and Xindonggang Pharmaceutical have passed the consistency evaluation.
â–Yangzijiang: dexmedetomidine hydrochloride injection
Recently, Yangzijiang Pharmaceutical Group obtained the production approval of the new three-category drug “dexmedetomidine hydrochloride injection†approved by CFDA.
According to the provisions of Circular No. 230 of the General Administration of 2015, the generic drugs declared and approved for listing after the implementation of the new registration classification will be accepted and reviewed and approved according to the principle of consistency with the quality and efficacy of the original drug.
This means that Yangzijiang Pharmaceutical's approved dexmedetomidine hydrochloride injection was the first to pass the consistency evaluation and entered the China Listed Drug List.
â–上è¯: Captopril tablets
On July 11, Shanghai Pharmaceutical announced that its holding subsidiary Changzhou Pharmaceutical Factory Co., Ltd. received the “Approval for Drug Replenishment Application†issued by the State Drug Administration for captopril tablets (Approval No.: 2018B03175), which passed the drug. Generic drug consistency evaluation.
In December 2017, Changzhou Pharmaceutical submitted an application to the State Food and Drug Administration for the consistency evaluation of the drug generic drug and was accepted. In the same year, the sales revenue of the drug was RMB 78.87 million.
As of the date of this announcement, the major manufacturers of the drug in China include Shanghai Xudong Haipu Pharmaceutical Co., Ltd., Shandong Luoxin Pharmaceutical Group Co., Ltd., and Sino-US Shanghai Squibb Pharmaceutical Co., Ltd.
â– stone medicine: captopril tablets
On July 10, Shijiazhuang Group announced that the Group's captopril tablets (25mg) had been approved by the State Drug Administration for approval of the quality and efficacy of generic drugs, and became the first in the country to pass the same Sexual evaluation of the enterprise.
The product is mainly used to treat high blood pressure and heart failure. Captopril tablets are one of the key products of the Group's blood pressure lowering products. Through the consistency evaluation, it indicates that the drug is consistent with the quality and efficacy of the original drug, and the clinical replacement of the original drug can be realized.
â–Yangzijiang: Amlodipine besylate tablets
On July 5, Xinhuanet reported that amlodipine besylate tablets (trade name: Randy) of Yangzijiang Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd. passed the evaluation of the consistency of quality and efficacy of generic drugs.
The original drug of amlodipine besylate tablets was the bioactive product of Pfizer Inc. of the United States. After the consistency evaluation of amlodipine besylate produced by Jiangsu Huanghe Pharmaceutical Co., Ltd. in February this year, Heine Pharmaceuticals It became the second enterprise in the country to pass the consistency evaluation of this variety.
â–先声è¯ä¸š: montmorillonite powder
On July 5, the official website of Xiansheng Pharmaceutical announced that it was inquired by the database of the State Drug Administration, and the pharmaceutical company of Xiansheng Pharmaceutical Group Co., Ltd. "De-sparing", through the consistency evaluation of generic drugs.
In fact, on June 28, Tibet Yiming Xiya Pharmaceutical Technology Co., Ltd. announced that the “Montmorillonite Powder (3g)†of Sichuan Weiao Pharmaceutical Co., Ltd., a wholly-owned subsidiary, is consistent with the quality and efficacy of generic drugs. Sexual evaluation.
â–Jiangsu Haosen: Imatinib
On July 5th, Jiangsu Haosen confirmed that it had received the approval of the drug “Imatinib†(trade name: Wei Wei) issued by the CFDA, and became the first company to pass the consistency evaluation.
The original research drug "Gleevec", together with the movie "I am not a drug god" released not long ago, became a hot topic at the time.
通过Through the end of 2018, the "289 Catalogue" is difficult to complete.
In order to encourage enterprises to actively review, the implementation of the State Council's "Opinions on the evaluation of the consistency of quality and efficacy of generic drugs" has given a number of favorable policies.
However, in this document of the State Council, it is also clearly stated that “the number of production enterprises that have passed the consistency evaluation of the same variety of drugs has reached more than three, and the varieties that have not passed the consistency evaluation are no longer selected in the centralized procurement of drugs.â€
â–Zhejiang Haizheng: rosuvastatin calcium tablets, through consistency evaluation
On July 24th, Zhejiang Hisun Pharmaceutical released the “Announcement on the Consistency Evaluation of Rosuvastatin Calcium Tablets through Generic Drugsâ€. It said that it has received the "Approval of Drug Replenishment Application" issued by the State Food and Drug Administration for rosuvastatin calcium tablets, which is evaluated by the consistency of the quality and efficacy of generic drugs.
According to the announcement, Haizheng Pfizer Pharmaceutical Co., Ltd. (now renamed as: Huihui Pharmaceutical Co., Ltd.) is the marketing license holder of this product, and Haizheng Pharmaceutical Co., Ltd. as a manufacturing enterprise.
Up to now, there have been two pharmaceutical companies with rosuvastatin calcium tablets, through the consistency evaluation, respectively, Zhejiang Jingxin and Zhejiang Haizheng. Zhejiang Jingxin passed the date of February 14, 2018.
Since December 29, 2017, the former State Food and Drug Administration has released the first batch of drugs that have passed the consistency evaluation, and there are more than 50 products that stand out. In July, nine drugs passed smoothly.
â–æµ·Cisco: flupirtine to melilizine tablets
On July 19th, Hai Cisco issued an announcement that the generic drug product “Flupiride Till Melistrol Tablets†developed by the company received a notification of conformity evaluation and received the trademark name “Le Pan®â€. Mainly used for mild/moderate depression and anxiety, neurasthenia, psychogenic depression, depressive neurosis and other symptoms.
The original developer of this variety was the flupirtine militazine tablets of Lingbei Pharmaceutical of Denmark, which was first listed in Austria in 1971.
â–ä¹æ™®åŒ»ç–—: atorvastatin calcium tablets
On July 18th, Lepu (Beijing) Medical announced that its holding subsidiary, Zhejiang Xindonggang Pharmaceutical, received the “Approval of Pharmaceutical Supplement†for “Atorvastatin Calcium Tablets†on July 17. Both the 20mg and 10mg specifications passed the evaluation of the consistency of the quality and efficacy of the generic drug.
Atorvastatin calcium tablets are the largest drug in the field of cardiovascular disease treatment, with a domestic market capacity of nearly 16 billion. At present, there are 6 companies in the market that compete for nearly 16 billion market capacity. The original research market share of Pfizer Lipitor is nearly 60%, and the market is highly concentrated and monopolized.
Up to now, atorvastatin calcium tablets from Beijing Jialin and Xindonggang Pharmaceutical have passed the consistency evaluation.
â–Yangzijiang: dexmedetomidine hydrochloride injection
Recently, Yangzijiang Pharmaceutical Group obtained the production approval of the new three-category drug “dexmedetomidine hydrochloride injection†approved by CFDA.
According to the provisions of Circular No. 230 of the General Administration of 2015, the generic drugs declared and approved for listing after the implementation of the new registration classification will be accepted and reviewed and approved according to the principle of consistency with the quality and efficacy of the original drug.
This means that Yangzijiang Pharmaceutical's approved dexmedetomidine hydrochloride injection was the first to pass the consistency evaluation and entered the China Listed Drug List.
â–上è¯: Captopril tablets
On July 11, Shanghai Pharmaceutical announced that its holding subsidiary Changzhou Pharmaceutical Factory Co., Ltd. received the “Approval for Drug Replenishment Application†issued by the State Drug Administration for captopril tablets (Approval No.: 2018B03175), which passed the drug. Generic drug consistency evaluation.
In December 2017, Changzhou Pharmaceutical submitted an application to the State Food and Drug Administration for the consistency evaluation of the drug generic drug and was accepted. In the same year, the sales revenue of the drug was RMB 78.87 million.
As of the date of this announcement, the major manufacturers of the drug in China include Shanghai Xudong Haipu Pharmaceutical Co., Ltd., Shandong Luoxin Pharmaceutical Group Co., Ltd., and Sino-US Shanghai Squibb Pharmaceutical Co., Ltd.
â– stone medicine: captopril tablets
On July 10, Shijiazhuang Group announced that the Group's captopril tablets (25mg) had been approved by the State Drug Administration for approval of the quality and efficacy of generic drugs, and became the first in the country to pass the same Sexual evaluation of the enterprise.
The product is mainly used to treat high blood pressure and heart failure. Captopril tablets are one of the key products of the Group's blood pressure lowering products. Through the consistency evaluation, it indicates that the drug is consistent with the quality and efficacy of the original drug, and the clinical replacement of the original drug can be realized.
â–Yangzijiang: Amlodipine besylate tablets
On July 5, Xinhuanet reported that amlodipine besylate tablets (trade name: Randy) of Yangzijiang Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd. passed the evaluation of the consistency of quality and efficacy of generic drugs.
The original drug of amlodipine besylate tablets was the bioactive product of Pfizer Inc. of the United States. After the consistency evaluation of amlodipine besylate produced by Jiangsu Huanghe Pharmaceutical Co., Ltd. in February this year, Heine Pharmaceuticals It became the second enterprise in the country to pass the consistency evaluation of this variety.
â–先声è¯ä¸š: montmorillonite powder
On July 5, the official website of Xiansheng Pharmaceutical announced that it was inquired by the database of the State Drug Administration, and the pharmaceutical company of Xiansheng Pharmaceutical Group Co., Ltd. "De-sparing", through the consistency evaluation of generic drugs.
In fact, on June 28, Tibet Yiming Xiya Pharmaceutical Technology Co., Ltd. announced that the “Montmorillonite Powder (3g)†of Sichuan Weiao Pharmaceutical Co., Ltd., a wholly-owned subsidiary, is consistent with the quality and efficacy of generic drugs. Sexual evaluation.
â–Jiangsu Haosen: Imatinib
On July 5th, Jiangsu Haosen confirmed that it had received the approval of the drug “Imatinib†(trade name: Wei Wei) issued by the CFDA, and became the first company to pass the consistency evaluation.
The original research drug "Gleevec", together with the movie "I am not a drug god" released not long ago, became a hot topic at the time.
通过Through the end of 2018, the "289 Catalogue" is difficult to complete.
In order to encourage enterprises to actively review, the implementation of the State Council's "Opinions on the evaluation of the consistency of quality and efficacy of generic drugs" has given a number of favorable policies.
However, in this document of the State Council, it is also clearly stated that “the number of production enterprises that have passed the consistency evaluation of the same variety of drugs has reached more than three, and the varieties that have not passed the consistency evaluation are no longer selected in the centralized procurement of drugs.â€
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