Collects large varieties of omeprazole enteric-coated tablets, which are converted from prescription drugs to over-the-counter drugs

On August 26, the State Food and Drug Administration website published an announcement

On August 26, the State Food and Drug Administration website published an announcement

The announcement states:

According to the provisions of the Measures for the Classification and Administration of Prescription Drugs and Over-the-Counter Drugs (Trial Implementation) (formerly Order No.

The holders of the relevant drug marketing authorizations are requested to submit the revised instructions to the provincial drug supervision and management departments for the record before May 24, 2023, in accordance with the "Measures for the Administration of Drug Registration" and other relevant provisions, and promptly notify the relevant medical institutions, drug trading enterprises and other units

The contents of the instructions other than those specified in the model over-the-counter drug instructions shall be carried out

Annex 1:

Scan the code to download Annex 2:

Sample over-the-counter drug instructions

Omeprazole is a proton pump inhibitor (PPI) that can effectively inhibit gastric acid secretion, which is mainly used clinically for the treatment of duodenal ulcer, Dro-Ai syndrome (gastrinoma), gastric ulcer and reflux esophagitis; It can also be used with amoxicillin and clindamycin or with metronidazole and clarithromycin to kill Helicobacter pylori

According to data from Minnet, in the competition pattern of terminal PPI drugs in urban physical pharmacies in China, the TOP3 varieties of oral medication are: omeprazole (40.
43%), rabeprazole (18.
80%), and espaprazole (18.
42%)
.

According to the forecast data of The Intranet, the total sales of PPI oral drug TOP5 brands will exceed 1 billion yuan in 2021, and the total market share will reach 39.
78%.

Omeprazole enteric-coated tablets are developed by AstraZeneca, and at present, the omeprazole enteric-coated tablets of Shandong New Era Pharmaceutical Co.
, Ltd.
, Hunan Sheng Pharmaceutical Co.
, Ltd.
and Sinopharm Group Industrial Co.
, Ltd.
have passed the approval
of the quality and efficacy consistency evaluation of generic drugs by the State Drug Administration.

After inquiring about the website of the State Food and Drug Administration, there are currently 16 domestic omeprazole enteric-coated tablets production approvals, and the main manufacturers in China are: Chenxin Pharmaceutical Co.
, Ltd.
, Qingdao Shuang whale Pharmaceutical Co.
, Ltd.
and so on
.

On December 7, 2021, the Guangdong Provincial Drug Trading Center issued the "Notice on Announcing the Results of the Selection of 45 Pharmaceutical Groups including Guangdong Alliance Amoxicillin", and the omeprazole enteric-coated tablets with a specification of 20mg of Hunan Sheng Pharmaceutical Co.
, Ltd.
were selected
at a price of 0.
34 yuan / tablet.

The announcement states:

According to the provisions of the Measures for the Classification and Administration of Prescription Drugs and Over-the-Counter Drugs (Trial Implementation) (formerly Order No.
10 of the State Drug Administration), after the State Drug Administration organized demonstration and review, omeprazole enteric-coated tablets were converted from prescription drugs to over-the-counter drugs
.
The list of varieties and their sample over-the-counter drug instructions are published
together.

The holders of the relevant drug marketing authorizations are requested to submit the revised instructions to the provincial drug supervision and management departments for the record before May 24, 2023, in accordance with the "Measures for the Administration of Drug Registration" and other relevant provisions, and promptly notify the relevant medical institutions, drug trading enterprises and other units
of the revised contents of the instructions.

The contents of the instructions other than those specified in the model over-the-counter drug instructions shall be carried out
in accordance with the original approval documents.
Where drug labels involve relevant content, they shall be revised
together.
Drugs produced on the date of filing by the holder of the drug marketing authorization shall not continue to use the original drug instructions
.

Annex 1:

Scan the code to download Annex 2:

Sample over-the-counter drug instructions

Omeprazole is a proton pump inhibitor (PPI) that can effectively inhibit gastric acid secretion, which is mainly used clinically for the treatment of duodenal ulcer, Dro-Ai syndrome (gastrinoma), gastric ulcer and reflux esophagitis; It can also be used with amoxicillin and clindamycin or with metronidazole and clarithromycin to kill Helicobacter pylori
.

According to data from Minnet, in the competition pattern of terminal PPI drugs in urban physical pharmacies in China, the TOP3 varieties of oral medication are: omeprazole (40.
43%), rabeprazole (18.
80%), and espaprazole (18.
42%)
.

According to the forecast data of The Intranet, the total sales of PPI oral drug TOP5 brands will exceed 1 billion yuan in 2021, and the total market share will reach 39.
78%.

Omeprazole enteric-coated tablets are developed by AstraZeneca, and at present, the omeprazole enteric-coated tablets of Shandong New Era Pharmaceutical Co.
, Ltd.
, Hunan Sheng Pharmaceutical Co.
, Ltd.
and Sinopharm Group Industrial Co.
, Ltd.
have passed the approval
of the quality and efficacy consistency evaluation of generic drugs by the State Drug Administration.

After inquiring about the website of the State Food and Drug Administration, there are currently 16 domestic omeprazole enteric-coated tablets production approvals, and the main manufacturers in China are: Chenxin Pharmaceutical Co.
, Ltd.
, Qingdao Shuang whale Pharmaceutical Co.
, Ltd.
and so on
.

On December 7, 2021, the Guangdong Provincial Drug Trading Center issued the "Notice on Announcing the Results of the Selection of 45 Pharmaceutical Groups including Guangdong Alliance Amoxicillin", and the omeprazole enteric-coated tablets with a specification of 20mg of Hunan Sheng Pharmaceutical Co.
, Ltd.
were selected
at a price of 0.
34 yuan / tablet.

The announcement states:

The announcement states:

According to the provisions of the Measures for the Classification and Administration of Prescription Drugs and Over-the-Counter Drugs (Trial Implementation) (formerly Order No.
10 of the State Drug Administration), after the State Drug Administration organized demonstration and review, omeprazole enteric-coated tablets were converted from prescription drugs to over-the-counter drugs
.
The list of varieties and their sample over-the-counter drug instructions are published
together.

According to the provisions of the Measures for the Classification and Administration of Prescription Drugs and Over-the-Counter Drugs (Trial Implementation) (formerly Order No.
10 of the State Drug Administration), after the State Drug Administration organized demonstration and review, omeprazole enteric-coated tablets were converted from prescription drugs to over-the-counter drugs
.
The list of varieties and their sample over-the-counter drug instructions are published
together.

The holders of the relevant drug marketing authorizations are requested to submit the revised instructions to the provincial drug supervision and management departments for the record before May 24, 2023, in accordance with the "Measures for the Administration of Drug Registration" and other relevant provisions, and promptly notify the relevant medical institutions, drug trading enterprises and other units
of the revised contents of the instructions.

The holders of the relevant drug marketing authorizations are requested to submit the revised instructions to the provincial drug supervision and management departments for the record before May 24, 2023, in accordance with the "Measures for the Administration of Drug Registration" and other relevant provisions, and promptly notify the relevant medical institutions, drug trading enterprises and other units
of the revised contents of the instructions.

The contents of the instructions other than those specified in the model over-the-counter drug instructions shall be carried out
in accordance with the original approval documents.
Where drug labels involve relevant content, they shall be revised
together.
Drugs produced on the date of filing by the holder of the drug marketing authorization shall not continue to use the original drug instructions
.

The contents of the instructions other than those specified in the model over-the-counter drug instructions shall be carried out
in accordance with the original approval documents.
Where drug labels involve relevant content, they shall be revised
together.
Drugs produced on the date of filing by the holder of the drug marketing authorization shall not continue to use the original drug instructions
.

Annex 1:

Annex 1: Annex 1:

Scan the code to download Annex 2:

Scan code to download attachment 2: scan code to download attachment 2: scan code to download attachment 2:

Sample over-the-counter drug instructions

Sample over-the-counter drug instructions

Omeprazole is a proton pump inhibitor (PPI) that can effectively inhibit gastric acid secretion, which is mainly used clinically for the treatment of duodenal ulcer, Dro-Ai syndrome (gastrinoma), gastric ulcer and reflux esophagitis; It can also be used with amoxicillin and clindamycin or with metronidazole and clarithromycin to kill Helicobacter pylori
.

According to data from Minnet, in the competition pattern of terminal PPI drugs in urban physical pharmacies in China, the TOP3 varieties of oral medication are: omeprazole (40.
43%), rabeprazole (18.
80%), and espaprazole (18.
42%)
.

According to the forecast data of The Intranet, the total sales of PPI oral drug TOP5 brands will exceed 1 billion yuan in 2021, and the total market share will reach 39.
78%.

Omeprazole enteric-coated tablets are developed by AstraZeneca, and at present, the omeprazole enteric-coated tablets of Shandong New Era Pharmaceutical Co.
, Ltd.
, Hunan Sheng Pharmaceutical Co.
, Ltd.
and Sinopharm Group Industrial Co.
, Ltd.
have passed the approval
of the quality and efficacy consistency evaluation of generic drugs by the State Drug Administration.

After inquiring about the website of the State Food and Drug Administration, there are currently 16 domestic omeprazole enteric-coated tablets production approvals, and the main manufacturers in China are: Chenxin Pharmaceutical Co.
, Ltd.
, Qingdao Shuang whale Pharmaceutical Co.
, Ltd.
and so on
.

On December 7, 2021, the Guangdong Provincial Drug Trading Center issued the "Notice on Announcing the Results of the Selection of 45 Pharmaceutical Groups including Guangdong Alliance Amoxicillin", and the omeprazole enteric-coated tablets with a specification of 20mg of Hunan Sheng Pharmaceutical Co.
, Ltd.
were selected
at a price of 0.
34 yuan / tablet.