-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
[Pharmaceutical Network Industry News] On April 18, the website of the State Food and Drug Administration released the "Announcement of the State Food and Drug Administration on Cancellation of 223 Drug Registration Certificates such as Rosiglitazone Maleate Tablets (No.
34 of 2022)"
.
According to the content of the announcement, in accordance with the relevant provisions of the "Implementation Regulations of the Drug Administration Law of the People's Republic of China" and the "Administrative Measures for Drug Registration", the State Drug Administration has decided to cancel 223 drug registration certificates including rosiglitazone maleate tablets
.
A total of 143 drugs have been cancelled this time, including rosiglitazone maleate tablets, cimetidine tablets, prednisone acetate tablets, compound acetylsalicylic acid tablets, oxytetracycline tablets, and glipizide.
Tablets, cefoperazone sodium for injection and other large varieties, also include many varieties such as glipizide tablets, azithromycin tablets, cephalexin capsules, etc.
that have been included in the national centralized procurement
.
For example, the cancelled drug registration certificates include GlaxoSmithKline (Tianjin) Co.
, Ltd.
's rosiglitazone maleate tablets, approved by Chinese medicine H20031082, and approved by Chinese medicine H20020475; hypromellose eye drops, approved by Chinese medicine H20043228, Oxymetazoline Hydrochloride Eye Drops is approved by Chinese medicine H20083737
.
Sino-US Tianjin SmithKline Pharmaceutical Co.
, Ltd.
Cimetidine Tablets is approved by Chinese medicine H12020499 and Chinese medicine is approved by H12020498
.
Tianjin Pacific Pharmaceutical Co.
, Ltd.
Prednisone Acetate Tablets National Medicine Certificate H12020809; Dexamethasone Acetate Tablets National Medicine Certificate H12020293; Methyltestosterone Tablets National Medicine Certificate H12020792
.
Tianjin Tanabe Pharmaceutical Co.
, Ltd.
Ecabet Sodium Granules approved by Chinese medicine H20103124
.
Inner Mongolia Haitian Pharmaceutical Co.
, Ltd.
Analgin Tablets National Medicine Certificate H15020986; Compound Sulfadiazine Tablets National Medicine Certificate H15020988; Compound Acetylsalicylic Acid Tablets National Medicine Certificate H15020989; Sulfamidine Tablets National Medicine Certificate H15020992; Chloramphenicol tablets are approved by H15020283; Tetracycline tablets are approved by H15020927; Oxytetracycline tablets are approved by H15020929
.
Pfizer Pharmaceuticals Co.
, Ltd.
Glipizide Tablets National Medicine Certificate H20054471; Azithromycin Tablets National Medicine Certificate H10960168; Cefoperazone Sodium for Injection National Medicine Certificate H21021895, Chinese Medicine Certificate H19994141
;
A total of 31 manufacturing companies have applied for cancellation, including many multinational companies such as GlaxoSmithKline, Pfizer, and Allergan
Inc.
In addition, according to the review, Ningxia Qiyuan National Pharmaceutical Co.
, Ltd.
has cancelled 101 drug registration certificates this time, including vitamin B1 calcium chewable tablets, calcium lactate tablets, calcium gluconate tablets, compound theophylline ephedrine tablets, etc.
; Suzhou Yifan Pharmaceutical Co.
, Ltd.
Co.
, Ltd.
has 20 drug registration certificates cancelled this time, including Qutong Tablets, Furazolidone Tablets, Furazolidone Tablets, etc.
; Hainan Boda Pharmaceutical Factory has cancelled 18 drug registration certificates this time; Hainan General Union Pharmaceutical Co.
, Ltd.
has 14; 10 Ningxia Kangya Pharmaceutical Co.
,
Ltd.
It is reported that most of the products cancelled by Ningxia Qiyuan this time were approved in 2014.
This cancellation is all overdue and legally cancelled, which will not affect the production and operation of the enterprise
.
After the drug is cancelled, the enterprise will not be allowed to produce the drug before a new registration certificate is approved
.
Screenshots of some canceled products Complete canceled list: see related data download below
34 of 2022)"
.
According to the content of the announcement, in accordance with the relevant provisions of the "Implementation Regulations of the Drug Administration Law of the People's Republic of China" and the "Administrative Measures for Drug Registration", the State Drug Administration has decided to cancel 223 drug registration certificates including rosiglitazone maleate tablets
.
A total of 143 drugs have been cancelled this time, including rosiglitazone maleate tablets, cimetidine tablets, prednisone acetate tablets, compound acetylsalicylic acid tablets, oxytetracycline tablets, and glipizide.
Tablets, cefoperazone sodium for injection and other large varieties, also include many varieties such as glipizide tablets, azithromycin tablets, cephalexin capsules, etc.
that have been included in the national centralized procurement
.
For example, the cancelled drug registration certificates include GlaxoSmithKline (Tianjin) Co.
, Ltd.
's rosiglitazone maleate tablets, approved by Chinese medicine H20031082, and approved by Chinese medicine H20020475; hypromellose eye drops, approved by Chinese medicine H20043228, Oxymetazoline Hydrochloride Eye Drops is approved by Chinese medicine H20083737
.
Sino-US Tianjin SmithKline Pharmaceutical Co.
, Ltd.
Cimetidine Tablets is approved by Chinese medicine H12020499 and Chinese medicine is approved by H12020498
.
Tianjin Pacific Pharmaceutical Co.
, Ltd.
Prednisone Acetate Tablets National Medicine Certificate H12020809; Dexamethasone Acetate Tablets National Medicine Certificate H12020293; Methyltestosterone Tablets National Medicine Certificate H12020792
.
Tianjin Tanabe Pharmaceutical Co.
, Ltd.
Ecabet Sodium Granules approved by Chinese medicine H20103124
.
Inner Mongolia Haitian Pharmaceutical Co.
, Ltd.
Analgin Tablets National Medicine Certificate H15020986; Compound Sulfadiazine Tablets National Medicine Certificate H15020988; Compound Acetylsalicylic Acid Tablets National Medicine Certificate H15020989; Sulfamidine Tablets National Medicine Certificate H15020992; Chloramphenicol tablets are approved by H15020283; Tetracycline tablets are approved by H15020927; Oxytetracycline tablets are approved by H15020929
.
Pfizer Pharmaceuticals Co.
, Ltd.
Glipizide Tablets National Medicine Certificate H20054471; Azithromycin Tablets National Medicine Certificate H10960168; Cefoperazone Sodium for Injection National Medicine Certificate H21021895, Chinese Medicine Certificate H19994141
;
A total of 31 manufacturing companies have applied for cancellation, including many multinational companies such as GlaxoSmithKline, Pfizer, and Allergan
Inc.
In addition, according to the review, Ningxia Qiyuan National Pharmaceutical Co.
, Ltd.
has cancelled 101 drug registration certificates this time, including vitamin B1 calcium chewable tablets, calcium lactate tablets, calcium gluconate tablets, compound theophylline ephedrine tablets, etc.
; Suzhou Yifan Pharmaceutical Co.
, Ltd.
Co.
, Ltd.
has 20 drug registration certificates cancelled this time, including Qutong Tablets, Furazolidone Tablets, Furazolidone Tablets, etc.
; Hainan Boda Pharmaceutical Factory has cancelled 18 drug registration certificates this time; Hainan General Union Pharmaceutical Co.
, Ltd.
has 14; 10 Ningxia Kangya Pharmaceutical Co.
,
Ltd.
It is reported that most of the products cancelled by Ningxia Qiyuan this time were approved in 2014.
This cancellation is all overdue and legally cancelled, which will not affect the production and operation of the enterprise
.
After the drug is cancelled, the enterprise will not be allowed to produce the drug before a new registration certificate is approved
.
Screenshots of some canceled products Complete canceled list: see related data download below