Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Chemical-drug catalogue
Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Anacor Pharmaceuticals, Inc. | Pharmacia and Upjohn Company LLC | 国药准字HJ20200022 | 2020/07/29 | 2% | 进口原研药品 | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 23 distinct approval numbers and 22 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 福元药业有限公司 | 国药准字H20264650 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010100177 | NHSA |
| 广东华润顺峰药业有限公司 | 国药准字H20255867 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010100340 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254896 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010101503 | NHSA |
| 湖北恒安芙林药业股份有限公司 | 国药准字H20256013 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010101808 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20265204 | 2%(30g∶0.6g) | 乙 | XD11AHK139F001010102180 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20264993 | 2%(30g∶0.6g) | 乙 | XD11AHK139F001010102959 | NHSA |
| 杭州朱养心药业有限公司 | 国药准字H20255740 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010104522 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20263904 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010104606 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20264173 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010104942 | NHSA |
| 湖南明瑞制药股份有限公司 | 国药准字H20256048 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010105001 | NHSA |
| 南京海纳制药有限公司 | 国药准字H20264170 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010180537 | NHSA |
| Anacor Pharmaceuticals, LLC | 国药准字HJ20200022 | 2% | 乙 | XD11AHK139F001010182999 | NHSA |
| 山东辰欣佛都药业股份有限公司 | 国药准字H20256015 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010183191 | NHSA |
| 河北合渡药业有限公司 | 国药准字H20265998 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010183394 | NHSA |
| 福建省宝诺医药研发有限公司 | 国药准字H20264314 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010183544 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20255380 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010183549 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20255487 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010184221 | NHSA |
| 浙江寰领医药科技有限公司 | 国药准字H20264421 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010184239 | NHSA |
| 南京万融健诚医药科技有限公司 | 国药准字H20244979 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010184314 | NHSA |
| 苏州高迈药业有限公司 | 国药准字H20264385 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010184410 | NHSA |
| 湖北民康药业集团有限公司 | 国药准字H20265947 | 2%(30g:0.6g) | 乙 | XD11AHK139F001010184564 | NHSA |
| 杭州领业医药科技有限公司 | 国药准字H20254892 | 2%(60g:1.2g) | 乙 | XD11AHK139F001010184874 | NHSA |
| Anacor Pharmaceuticals, LLC | 国药准字HJ20200022 | 2% | 乙 | XD11AHK139F001020182999 | NHSA |
| 湖北民康药业集团有限公司 | 国药准字H20265948 | 2%(60g:1.2g) | 乙 | XD11AHK139F001020184564 | NHSA |
| Anacor Pharmaceuticals, LLC | 国药准字HJ20200022 | 2% | 乙 | XD11AHK139F001030182999 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 28 filings and 26 distinct first applicants.
Generic 25 · Supplement 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 哈尔滨葵花药业有限公司;江苏知原药业股份有限公司 | CYHS2503831 | Generic | 2025/10/30 | Not stated by source | CDE |
| 江苏迪赛诺制药有限公司 | CYHS2601187 | Generic | 2026/05/20 | Not stated by source | CDE |
| 江苏正大清江制药有限公司 | CYHS2502537 | Generic | 2025/07/16 | Not stated by source | CDE |
| 苏州东瑞制药有限公司 | CYHS2503518 | Generic | 2025/09/25 | Not stated by source | CDE |
| 江苏东科康德药业有限公司;华益泰康药业股份有限公司 | CYHS2504411 | Generic | 2025/12/26 | Not stated by source | CDE |
| 苏州第四制药厂有限公司 | CYHS2600855 | Generic | 2026/04/14 | Not stated by source | CDE |
| 哈药集团生物工程有限公司 | CYHS2601367 | Generic | 2026/06/10 | Not stated by source | CDE |
| 湖北成田药业有限公司 | CYHS2601104 | Generic | 2026/05/13 | Not stated by source | CDE |
| 山东方明药业集团股份有限公司 | CYHS2600938 | Generic | 2026/04/23 | Not stated by source | CDE |
| 马应龙药业集团股份有限公司 | CYHS2600823 | Generic | 2026/04/09 | Not stated by source | CDE |
| 湖南斯奇生物制药有限公司;成都市海通药业有限公司 | CYHS2600433 | Generic | 2026/02/10 | Not stated by source | CDE |
| 湖南斯奇生物制药有限公司;成都市海通药业有限公司 | CYHS2600432 | Generic | 2026/02/10 | Not stated by source | CDE |
| 哈尔滨大中制药有限公司 | CYHS2600431 | Generic | 2026/02/10 | Not stated by source | CDE |
| 湖北科益药业股份有限公司 | CYHS2600243 | Generic | 2026/01/21 | Not stated by source | CDE |
| 海南海灵化学制药有限公司 | CYHS2600180 | Generic | 2026/01/14 | Not stated by source | CDE |
| 湖南迪诺制药股份有限公司 | CYHS2600094 | Generic | 2026/01/08 | Not stated by source | CDE |
| 国药集团三益药业（芜湖）有限公司 | CYHS2504438 | Generic | 2025/12/27 | Not stated by source | CDE |
| 重庆希尔安药业有限公司 | CYHS2504330 | Generic | 2025/12/19 | Not stated by source | CDE |
| 津华医药科技（湖州）有限公司;重庆博腾药业有限公司 | CYHS2504256 | Generic | 2025/12/11 | Not stated by source | CDE |
| 北京京丰制药（河北）有限公司 | CYHS2504114 | Generic | 2025/11/29 | Not stated by source | CDE |
| 药大制药有限公司 | CYHS2504104 | Generic | 2025/11/28 | Not stated by source | CDE |
| 鲁南贝特制药有限公司 | CYHS2503828 | Generic | 2025/10/29 | Not stated by source | CDE |
| 佑华医药科技有限公司;成都市海通药业有限公司 | CYHS2503633 | Generic | 2025/10/11 | Not stated by source | CDE |
| 武汉益博元医药科技有限公司;杭州领业医药科技有限公司 | CYHS2502633 | Generic | 2025/07/22 | Not stated by source | CDE |
| 重庆华邦制药有限公司 | CYHS2502124 | Generic | 2025/06/14 | Not stated by source | CDE |
| 广东科泓药业有限公司 | CYHB2601958 | Supplement | 2026/10/26 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHB2601976 | Supplement | 2026/10/29 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHB2601975 | Supplement | 2026/10/29 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 12 filings and 11 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏迪赛诺制药有限公司 | CYHS2601187 | Generic | 2026/05/20 | Not stated by source | CDE |
| 苏州第四制药厂有限公司 | CYHS2600855 | Generic | 2026/04/14 | Not stated by source | CDE |
| 哈药集团生物工程有限公司 | CYHS2601367 | Generic | 2026/06/10 | Not stated by source | CDE |
| 湖北成田药业有限公司 | CYHS2601104 | Generic | 2026/05/13 | Not stated by source | CDE |
| 山东方明药业集团股份有限公司 | CYHS2600938 | Generic | 2026/04/23 | Not stated by source | CDE |
| 马应龙药业集团股份有限公司 | CYHS2600823 | Generic | 2026/04/09 | Not stated by source | CDE |
| 湖南斯奇生物制药有限公司;成都市海通药业有限公司 | CYHS2600433 | Generic | 2026/02/10 | Not stated by source | CDE |
| 湖南斯奇生物制药有限公司;成都市海通药业有限公司 | CYHS2600432 | Generic | 2026/02/10 | Not stated by source | CDE |
| 哈尔滨大中制药有限公司 | CYHS2600431 | Generic | 2026/02/10 | Not stated by source | CDE |
| 湖北科益药业股份有限公司 | CYHS2600243 | Generic | 2026/01/21 | Not stated by source | CDE |
| 海南海灵化学制药有限公司 | CYHS2600180 | Generic | 2026/01/14 | Not stated by source | CDE |
| 湖南迪诺制药股份有限公司 | CYHS2600094 | Generic | 2026/01/08 | Not stated by source | CDE |
API registrations
Non-component matches: 30 companies with A status and 9 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 克立硼罗 | 山东大医精诚药业有限公司 | Y20260000724 | I | Exact ingredient | 2026/09/02 | CDE |
| 克立硼罗 | 江苏联环药业股份有限公司 | Y20260000008 | I | Exact ingredient | 2026/02/03 | CDE |
| 克立硼罗 | 山东铂源药业股份有限公司 | Y20250001376 | I | Exact ingredient | 2025/12/17 | CDE |
| 克立硼罗 | 上海锦帝九州药业（安阳）有限公司 | Y20250001097 | I | Exact ingredient | 2025/10/16 | CDE |
| 克立硼罗 | 山东方明药业集团股份有限公司 | Y20250000715 | I | Exact ingredient | 2025/08/14 | CDE |
| 克立硼罗 | 浙江华海建诚药业有限公司 | Y20250000789 | I | Exact ingredient | 2025/08/06 | CDE |
| 克立硼罗 | 重庆胜凯制药有限公司 | Y20250000473 | A | Exact ingredient | 2026/11/04 | CDE |
| 克立硼罗 | 兰州东瑞制药有限公司 | Y20250000195 | I | Exact ingredient | 2025/03/18 | CDE |
| 克立硼罗 | 浙江九洲药业股份有限公司 | Y20240001350 | A | Exact ingredient | 2026/06/01 | CDE |
| 克立硼罗 | 哈药集团三精明水药业有限公司 | Y20240001304 | I | Exact ingredient | 2024/12/12 | CDE |
| 克立硼罗 | 海南葫芦娃药业集团股份有限公司 | Y20240001257 | I | Exact ingredient | 2024/12/04 | CDE |
| 克立硼罗 | 江苏润安制药有限公司 | Y20240001060 | A | Exact ingredient | 2026/05/15 | CDE |
| 克立硼罗 | 重庆博腾制药科技股份有限公司 | Y20240001071 | A | Exact ingredient | 2026/04/29 | CDE |
| 克立硼罗 | 北京福元医药股份有限公司 | Y20240000682 | A | Exact ingredient | 2025/10/22 | CDE |
| 克立硼罗 | 亚宝药业集团股份有限公司 | Y20240000468 | A | Exact ingredient | 2025/11/14 | CDE |
| 克立硼罗 | 徐州万邦金桥制药有限公司 | Y20240000561 | A | Exact ingredient | 2026/04/10 | CDE |
| 克立硼罗 | 北京金城泰尔制药有限公司 | Y20240000380 | A | Exact ingredient | 2025/09/30 | CDE |
| 克立硼罗 | 宜昌天睿生物医药有限责任公司 | Y20240000269 | A | Exact ingredient | 2025/09/15 | CDE |
| 克立硼罗 | 山西振东泰盛制药有限公司 | Y20240000361 | A | Exact ingredient | 2025/12/17 | CDE |
| 克立硼罗 | 安徽普利药业有限公司 | Y20240000303 | A | Exact ingredient | 2026/09/03 | CDE |
| 克立硼罗 | 浙江赛默制药有限公司 | Y20230001078 | A | Exact ingredient | 2025/06/26 | CDE |
| 克立硼罗 | 湖南明瑞制药股份有限公司 | Y20230000744 | A | Exact ingredient | 2025/03/14 | CDE |
| 克立硼罗 | 山东诚汇双达药业有限公司 | Y20230000985 | A | Exact ingredient | 2026/05/20 | CDE |
| 克立硼罗 | 湖北恒安芙林药业股份有限公司 | Y20230000967 | A | Exact ingredient | 2026/08/08 | CDE |
| 克立硼罗 | 中山万汉制药有限公司 | Y20230000954 | A | Exact ingredient | 2025/08/11 | CDE |
| 克立硼罗 | 山东辰龙药业有限公司 | Y20230000908 | A | Exact ingredient | 2026/05/20 | CDE |
| 克立硼罗 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20230000653 | A | Exact ingredient | 2024/12/13 | CDE |
| 克立硼罗 | 绍兴民生医药股份有限公司 | Y20230000426 | A | Exact ingredient | 2025/03/25 | CDE |
| 克立硼罗 | 四川伊诺达博医药科技有限公司 | Y20230000644 | A | Exact ingredient | 2025/06/03 | CDE |
| 克立硼罗 | 山东新时代药业有限公司 | Y20230000380 | A | Exact ingredient | 2025/03/19 | CDE |
| 克立硼罗 | 江西科睿药业有限公司 | Y20230000260 | A | Exact ingredient | 2025/08/01 | CDE |
| 克立硼罗 | 齐鲁制药有限公司 | Y20230000191 | A | Exact ingredient | 2024/10/25 | CDE |
| 克立硼罗 | 南通常佑药业科技有限公司 | Y20220001301 | A | Exact ingredient | 2024/08/15 | CDE |
| 克立硼罗 | 上海迪赛诺化学制药有限公司 | Y20220001304 | A | Exact ingredient | 2025/06/26 | CDE |
| 克立硼罗 | 江西同和药业股份有限公司 | Y20220001177 | A | Exact ingredient | 2024/09/10 | CDE |
| 克立硼罗 | 长治市元延医药科技有限公司 | Y20220001261 | A | Exact ingredient | 2026/07/11 | CDE |
| 克立硼罗 | 四川新开元制药有限公司 | Y20220001073 | A | Exact ingredient | 2026/06/16 | CDE |
| 克立硼罗 | 南京海纳制药有限公司 | Y20220000559 | A | Exact ingredient | 2024/02/08 | CDE |
| 克立硼罗 | Honour Lab Limited, Unit-Ⅲ | Y20210000553 | A | Exact ingredient | 2025/07/29 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
What changed recently?
Last 90 days, ordered by fact date. Marketing approvals, supplements, notices and review changes are labelled separately.
This source was last successfully updated at 2026/11/04 18:32; current coverage may be incomplete.
-
2026/11/03No longer listed under review
山东达冠医药科技有限公司;赤峰赛林泰药业有限公司
CYHS2501906
Fact date: 2026/11/03 · Site observation date: 2026/11/03
Accepted: 2025/05/28
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/29Accepted
-
2026/10/29Accepted
-
2026/10/26Accepted
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/05 06:45
- Chemical-drug catalogue
- Last successful update: 2026/11/05 06:39
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/05 06:40
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/04 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-21 to 2026-11-05; 1 pages pending. Covers loaded notices only, not a complete historical approval database.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Fact dates are approval dates, acceptance dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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