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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 275 drug applications between 14 March 2023 and 20 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 50 drug names.

2023/03/14 – 2023/03/20

Period
2023/03/14 to 2023/03/20, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
275
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
1

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

275filings, 70 of them generic

By application type

Application typeFilings
Supplement108
Generic70
New drug42
Import re-registration35
Import13
Unspecified7

By drug type

Drug typeFilings
Chemical drug214
Therapeutic biologic31
TCM24
Biologic5
Prophylactic biologic1

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Amiodarone Hydrochloride Injection420
2Glucosamine Sulfate Capsules3351
3Cefalexin Granules for Oral Suspension310
4Sodium Valproate Concentrated Solution for Injection210
5Tacrolimus Ointment216
6Lansoprazole Enteric Capsules213
7Rivastigmine transdermal system211
8Orlistat Capsules218
9Amlodipine Besylate and Atorvastatin Calcium Tablets212
10氯雷他定糖浆 · No verified English name217

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

166 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bracco Imaging Italia S.r.L.2410
2Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized540
3MSD Pharma (Singapore) Pte. Ltd420
4Shanghai Chang Zheng Fu Min Jin Shan Pharmaceutical Co., Ltd. romanized330
5Guangxi Ji Min Tang Pharma Co., Ltd. romanized330
6Guangxi Yu Yuan Pharma Co., Ltd. romanized330
7AstraZeneca AB320
8Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized320
9CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD320
10Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized320

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

73 this week

AcceptedDrugApplicants
2023/03/20Generic · Class 3 Cefalexin Granules for Oral SuspensionCYHS2300841 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2023/03/20Generic · Class 3 Cefalexin Granules for Oral SuspensionCYHS2300840 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2023/03/20Generic · Class 3 Cefalexin Granules for Oral SuspensionCYHS2300839 Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized
2023/03/20Generic · Class 3 Diprophylline InjectionCYHS2300838 Name not romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
2023/03/20New drug · Class 1 人骨髓间充质干细胞注射液 · No verified English nameCXSL2300202 Jiu Zhi Tang Mei Ke (Beijing) Xi Bao Technology Co., Ltd. romanized
2023/03/18Generic · Class 3 Fluoxetine Hydrochloride Oral SolutionCYHS2300837 Changzhou Si Yao Pharmaceutical Co., Ltd. romanized
2023/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2300830 Hui Yu Kang Cheng (Zhejiang) Pharmaceuticals Technology Co., Ltd. romanized; Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized
2023/03/18Generic · Class 3 Sodium Valproate Concentrated Solution for InjectionCYHS2300829 Hui Yu Kang Cheng (Zhejiang) Pharmaceuticals Technology Co., Ltd. romanized; Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized
2023/03/18Generic · Class 3 Cetirizine Hydrochloride InjectionCYHS2300827 Shenyang Da Shan Pharmaceuticals Technology Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2023/03/18New drug · Class 1 SDT-T002细胞注射液 · No verified English nameCXSL2300201 Sai De Te (Beijing) Bio Gong Cheng Co., Ltd. romanized
2023/03/18New drug · Class 2.2; 2.4 SHR8028滴眼液 · No verified English nameCXHS2300039 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/03/18New drug · Class 2.4 Abiraterone Acetate TabletsCXHL2300322 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/03/18New drug · Class 1 TQB3823片 · No verified English nameCXHL2300321 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/03/18New drug · Class 1 TQB3823片 · No verified English nameCXHL2300320 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/03/18New drug · Class 2.2; 2.4 SBK011口服溶液 · No verified English nameCXHL2300319 Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized
2023/03/17Generic · Class 3 Famotidine InjectionCYHS2300825 Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized
2023/03/17Generic · Class 3 Levocetirizine dihydrochloride Oral SolutionCYHS2300824 Hubei Wei Sen Pharmaceutical Co., Ltd. romanized
2023/03/17New drug · Class 1 注射用DB-1310 · No verified English nameCXSL2300200 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/03/17New drug · Class 1 UCMYM802 · No verified English nameCXSL2300199 Shanghai You Ti Ji Sheng Biopharmaceuticals Co., Ltd. romanized
2023/03/17New drug · Class 1 TQB3455片 · No verified English nameCXHL2300318 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/03/17New drug · Class 1 TQB3455片 · No verified English nameCXHL2300317 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2023/03/17New drug · Class 2.2 BTP0611 · No verified English nameCXHL2300316 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2023/03/17New drug · Class 2.2 BTP0611 · No verified English nameCXHL2300315 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2023/03/16Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300808 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2023/03/16Generic · Class 3 Carbocisteine Oral SolutionCYHS2300805 Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/03/16Generic · Class 3 Carbocisteine Oral SolutionCYHS2300804 Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/03/16Generic · Class 3 Pentoxifylline InjectionCYHS2300803 Henan Xin Tai Pharma Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2023/03/16Generic · Class 3 Levetiracetam extended-release tabletsCYHS2300802 Hunan Dong Ting Pharma Co., Ltd. romanized
2023/03/16Generic · Class 3 Latamoxef Sodium for InjectionCYHS2300800 Shandong Lan Jing Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized
2023/03/16Generic · Class 3 Latamoxef Sodium for InjectionCYHS2300799 Shandong Lan Jing Bio Technology Co., Ltd. romanized; Shandong Run Ze Pharmaceutical Co., Ltd. romanized

43 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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