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: 0 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 |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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: 1 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| FUJI YAKUHIN CO., LTD. | 国药准字HJ20240164 | 2mg | 乙 | XM04ABD376A001010185383 | NHSA |
| FUJI YAKUHIN CO., LTD. | 国药准字HJ20240164 | 2mg | 乙 | XM04ABD376A001010285383 | 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: 49 filings and 25 distinct first applicants.
Generic 49
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏德源药业股份有限公司 | CYHS2601287 | Generic | 2026/06/04 | Not stated by source | CDE |
| 江苏德源药业股份有限公司 | CYHS2601285 | Generic | 2026/06/04 | Not stated by source | CDE |
| 江苏谦仁生物科技有限公司 | CYHS2601628 | Generic | 2026/07/08 | Not stated by source | CDE |
| 江苏谦仁生物科技有限公司 | CYHS2601627 | Generic | 2026/07/08 | Not stated by source | CDE |
| 湖南状元制药有限公司;九洲生物医药（台州）有限公司 | CYHS2602523 | Generic | 2026/10/14 | Not stated by source | CDE |
| 湖南状元制药有限公司;九洲生物医药（台州）有限公司 | CYHS2602522 | Generic | 2026/10/14 | Not stated by source | CDE |
| 新石阳光药业（河北）有限公司 | CYHS2602505 | Generic | 2026/10/13 | Not stated by source | CDE |
| 新石阳光药业（河北）有限公司 | CYHS2602504 | Generic | 2026/10/13 | Not stated by source | CDE |
| 兰西哈三联制药有限公司 | CYHS2602480 | Generic | 2026/10/10 | Not stated by source | CDE |
| 兰西哈三联制药有限公司 | CYHS2602479 | Generic | 2026/10/10 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2602438 | Generic | 2026/09/30 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2602437 | Generic | 2026/09/30 | Not stated by source | CDE |
| 海创药业股份有限公司 | CYHS2602323 | Generic | 2026/09/17 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2602223 | Generic | 2026/09/07 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2602221 | Generic | 2026/09/07 | Not stated by source | CDE |
| 浙江益汉制药有限公司 | CYHS2602122 | Generic | 2026/08/25 | Not stated by source | CDE |
| 浙江益汉制药有限公司 | CYHS2602121 | Generic | 2026/08/25 | Not stated by source | CDE |
| 九华华源药业股份有限公司;华益药业科技(安徽)有限公司 | CYHS2602113 | Generic | 2026/08/25 | Not stated by source | CDE |
| 九华华源药业股份有限公司;华益药业科技（安徽）有限公司 | CYHS2602112 | Generic | 2026/08/25 | Not stated by source | CDE |
| 湖南千金协力药业有限公司 | CYHS2602019 | Generic | 2026/08/14 | Not stated by source | CDE |
| 北京华素制药股份有限公司 | CYHS2601851 | Generic | 2026/07/31 | Not stated by source | CDE |
| 北京华素制药股份有限公司 | CYHS2601850 | Generic | 2026/07/31 | Not stated by source | CDE |
| 江西泰吉立生物制药有限公司 | CYHS2601739 | Generic | 2026/07/21 | Not stated by source | CDE |
| 江西泰吉立生物制药有限公司 | CYHS2601738 | Generic | 2026/07/21 | Not stated by source | CDE |
| 山东诺明康药物研究院有限公司;山东诺禾康药业有限公司 | CYHS2601708 | Generic | 2026/07/17 | Not stated by source | CDE |
| 山东诺明康药物研究院有限公司;山东诺禾康药业有限公司 | CYHS2601707 | Generic | 2026/07/17 | Not stated by source | CDE |
| 山东诺明康药物研究院有限公司;山东诺禾康药业有限公司 | CYHS2601706 | Generic | 2026/07/17 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2601568 | Generic | 2026/07/02 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2601567 | Generic | 2026/07/02 | Not stated by source | CDE |
| 辽宁鑫善源药业有限公司 | CYHS2601347 | Generic | 2026/06/09 | Not stated by source | CDE |
| 辽宁鑫善源药业有限公司 | CYHS2601346 | Generic | 2026/06/09 | Not stated by source | CDE |
| 辽宁鑫善源药业有限公司 | CYHS2601345 | Generic | 2026/06/09 | Not stated by source | CDE |
| 杭州中美华东制药有限公司 | CYHS2601340 | Generic | 2026/06/08 | Not stated by source | CDE |
| 四川国为制药有限公司 | CYHS2601256 | Generic | 2026/06/02 | Not stated by source | CDE |
| 四川国为制药有限公司 | CYHS2601255 | Generic | 2026/06/02 | Not stated by source | CDE |
| 桂林南药股份有限公司 | CYHS2601088 | Generic | 2026/05/12 | Not stated by source | CDE |
| 桂林南药股份有限公司 | CYHS2601087 | Generic | 2026/05/12 | Not stated by source | CDE |
| 杭州和康药业有限公司 | CYHS2601051 | Generic | 2026/05/08 | Not stated by source | CDE |
| 杭州和康药业有限公司 | CYHS2601050 | Generic | 2026/05/08 | Not stated by source | CDE |
| 广州大光制药有限公司 | CYHS2600512 | Generic | 2026/02/25 | Not stated by source | CDE |
| 广州大光制药有限公司 | CYHS2600510 | Generic | 2026/02/25 | Not stated by source | CDE |
| 山西泽辰医药科技有限公司;山西鑫煜制药股份有限公司 | CYHS2600158 | Generic | 2026/01/13 | Not stated by source | CDE |
| 山西泽辰医药科技有限公司;山西鑫煜制药股份有限公司 | CYHS2600156 | Generic | 2026/01/13 | Not stated by source | CDE |
| 天地恒一制药股份有限公司 | CYHS2504481 | Generic | 2025/12/30 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2503611 | Generic | 2025/10/10 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2503610 | Generic | 2025/10/10 | Not stated by source | CDE |
| 天地恒一制药股份有限公司 | CYHS2503112 | Generic | 2025/08/25 | Not stated by source | CDE |
| 安徽省先锋制药有限公司 | CYHS2602598 | Generic | 2026/10/22 | Not stated by source | CDE |
| 安徽省先锋制药有限公司 | CYHS2602597 | Generic | 2026/10/22 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 45 filings and 23 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏德源药业股份有限公司 | CYHS2601287 | Generic | 2026/06/04 | Not stated by source | CDE |
| 江苏德源药业股份有限公司 | CYHS2601285 | Generic | 2026/06/04 | Not stated by source | CDE |
| 江苏谦仁生物科技有限公司 | CYHS2601628 | Generic | 2026/07/08 | Not stated by source | CDE |
| 江苏谦仁生物科技有限公司 | CYHS2601627 | Generic | 2026/07/08 | Not stated by source | CDE |
| 湖南状元制药有限公司;九洲生物医药（台州）有限公司 | CYHS2602523 | Generic | 2026/10/14 | Not stated by source | CDE |
| 湖南状元制药有限公司;九洲生物医药（台州）有限公司 | CYHS2602522 | Generic | 2026/10/14 | Not stated by source | CDE |
| 新石阳光药业（河北）有限公司 | CYHS2602505 | Generic | 2026/10/13 | Not stated by source | CDE |
| 新石阳光药业（河北）有限公司 | CYHS2602504 | Generic | 2026/10/13 | Not stated by source | CDE |
| 兰西哈三联制药有限公司 | CYHS2602480 | Generic | 2026/10/10 | Not stated by source | CDE |
| 兰西哈三联制药有限公司 | CYHS2602479 | Generic | 2026/10/10 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2602438 | Generic | 2026/09/30 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2602437 | Generic | 2026/09/30 | Not stated by source | CDE |
| 海创药业股份有限公司 | CYHS2602323 | Generic | 2026/09/17 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2602223 | Generic | 2026/09/07 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2602221 | Generic | 2026/09/07 | Not stated by source | CDE |
| 浙江益汉制药有限公司 | CYHS2602122 | Generic | 2026/08/25 | Not stated by source | CDE |
| 浙江益汉制药有限公司 | CYHS2602121 | Generic | 2026/08/25 | Not stated by source | CDE |
| 九华华源药业股份有限公司;华益药业科技(安徽)有限公司 | CYHS2602113 | Generic | 2026/08/25 | Not stated by source | CDE |
| 九华华源药业股份有限公司;华益药业科技（安徽）有限公司 | CYHS2602112 | Generic | 2026/08/25 | Not stated by source | CDE |
| 湖南千金协力药业有限公司 | CYHS2602019 | Generic | 2026/08/14 | Not stated by source | CDE |
| 北京华素制药股份有限公司 | CYHS2601851 | Generic | 2026/07/31 | Not stated by source | CDE |
| 北京华素制药股份有限公司 | CYHS2601850 | Generic | 2026/07/31 | Not stated by source | CDE |
| 江西泰吉立生物制药有限公司 | CYHS2601739 | Generic | 2026/07/21 | Not stated by source | CDE |
| 江西泰吉立生物制药有限公司 | CYHS2601738 | Generic | 2026/07/21 | Not stated by source | CDE |
| 山东诺明康药物研究院有限公司;山东诺禾康药业有限公司 | CYHS2601708 | Generic | 2026/07/17 | Not stated by source | CDE |
| 山东诺明康药物研究院有限公司;山东诺禾康药业有限公司 | CYHS2601707 | Generic | 2026/07/17 | Not stated by source | CDE |
| 山东诺明康药物研究院有限公司;山东诺禾康药业有限公司 | CYHS2601706 | Generic | 2026/07/17 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2601568 | Generic | 2026/07/02 | Not stated by source | CDE |
| 齐鲁制药有限公司 | CYHS2601567 | Generic | 2026/07/02 | Not stated by source | CDE |
| 辽宁鑫善源药业有限公司 | CYHS2601347 | Generic | 2026/06/09 | Not stated by source | CDE |
| 辽宁鑫善源药业有限公司 | CYHS2601346 | Generic | 2026/06/09 | Not stated by source | CDE |
| 辽宁鑫善源药业有限公司 | CYHS2601345 | Generic | 2026/06/09 | Not stated by source | CDE |
| 杭州中美华东制药有限公司 | CYHS2601340 | Generic | 2026/06/08 | Not stated by source | CDE |
| 四川国为制药有限公司 | CYHS2601256 | Generic | 2026/06/02 | Not stated by source | CDE |
| 四川国为制药有限公司 | CYHS2601255 | Generic | 2026/06/02 | Not stated by source | CDE |
| 桂林南药股份有限公司 | CYHS2601088 | Generic | 2026/05/12 | Not stated by source | CDE |
| 桂林南药股份有限公司 | CYHS2601087 | Generic | 2026/05/12 | Not stated by source | CDE |
| 杭州和康药业有限公司 | CYHS2601051 | Generic | 2026/05/08 | Not stated by source | CDE |
| 杭州和康药业有限公司 | CYHS2601050 | Generic | 2026/05/08 | Not stated by source | CDE |
| 广州大光制药有限公司 | CYHS2600512 | Generic | 2026/02/25 | Not stated by source | CDE |
| 广州大光制药有限公司 | CYHS2600510 | Generic | 2026/02/25 | Not stated by source | CDE |
| 山西泽辰医药科技有限公司;山西鑫煜制药股份有限公司 | CYHS2600158 | Generic | 2026/01/13 | Not stated by source | CDE |
| 山西泽辰医药科技有限公司;山西鑫煜制药股份有限公司 | CYHS2600156 | Generic | 2026/01/13 | Not stated by source | CDE |
| 安徽省先锋制药有限公司 | CYHS2602598 | Generic | 2026/10/22 | Not stated by source | CDE |
| 安徽省先锋制药有限公司 | CYHS2602597 | Generic | 2026/10/22 | Not stated by source | CDE |
API registrations
Non-component matches: 1 companies with A status and 19 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 |
|---|---|---|---|---|---|---|
| 多替诺雷 | 河北华晨药业集团有限公司 | Y20260000734 | I | Exact ingredient | 2026/10/10 | CDE |
| 多替诺雷 | 泸州科瑞德制药有限公司 | Y20260000807 | I | Exact ingredient | 2026/09/24 | CDE |
| 多替诺雷 | 广州绿十字制药股份有限公司 | Y20260000785 | I | Exact ingredient | 2026/09/16 | CDE |
| 多替诺雷 | 江苏联环药业股份有限公司 | Y20260000753 | I | Exact ingredient | 2026/09/11 | CDE |
| 多替诺雷 | 四川新开元制药有限公司 | Y20260000713 | I | Exact ingredient | 2026/08/20 | CDE |
| 多替诺雷 | 武汉武药制药有限公司 | Y20260000645 | I | Exact ingredient | 2026/07/27 | CDE |
| 多替诺雷 | 山东艾格林制药有限公司 | Y20260000325 | I | Exact ingredient | 2026/05/27 | CDE |
| 多替诺雷 | 珠海海瑞德制药有限公司 | Y20260000266 | I | Exact ingredient | 2026/05/06 | CDE |
| 多替诺雷 | 华东医药（西安）博华制药有限公司 | Y20260000047 | I | Exact ingredient | 2026/04/27 | CDE |
| 多替诺雷 | 华北制药华胜有限公司 | Y20260000219 | I | Exact ingredient | 2026/04/08 | CDE |
| 多替诺雷 | 四川国为制药有限公司 | Y20260000125 | I | Exact ingredient | 2026/03/02 | CDE |
| 多替诺雷 | 湖北天舒药业有限公司 | Y20260000134 | I | Exact ingredient | 2026/02/27 | CDE |
| 多替诺雷 | 渭南瑞联制药有限责任公司 | Y20250001385 | I | Exact ingredient | 2026/01/29 | CDE |
| 多替诺雷 | 吉林省博大制药股份有限公司 | Y20250001494 | I | Exact ingredient | 2026/01/22 | CDE |
| 多替诺雷 | 江苏德源药业股份有限公司 | Y20250001328 | I | Exact ingredient | 2025/12/23 | CDE |
| 多替诺雷 | 山东济坤生物制药有限公司 | Y20250001188 | I | Exact ingredient | 2025/11/12 | CDE |
| 多替诺雷 | 上海迪赛诺化学制药有限公司 | Y20250001101 | I | Exact ingredient | 2025/11/10 | CDE |
| 多替诺雷 | 山东朗诺制药有限公司 | Y20250000686 | I | Exact ingredient | 2025/07/21 | CDE |
| 多替诺雷 | 广东先强药业有限公司 | Y20250000665 | I | Exact ingredient | 2025/07/08 | CDE |
| 多替诺雷 | 天地恒一制药股份有限公司 | Y20250000660 | A | Exact ingredient | 2026/10/12 | 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.
-
2026/10/22Accepted
-
2026/10/22Accepted
-
2026/10/16Approval-document delivery record
上海瀚合瑞医药科技有限公司
JTH2600197
Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03
View source · Table row 29 ↗ -
2026/10/14Accepted
湖南状元制药有限公司;九洲生物医药（台州）有限公司
CYHS2602523
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗ -
2026/10/14Accepted
湖南状元制药有限公司;九洲生物医药（台州）有限公司
CYHS2602522
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗ -
2026/10/13Accepted
-
2026/10/13Accepted
-
2026/10/10Accepted
-
2026/10/10Accepted
-
2026/09/30Accepted
-
2026/09/30Accepted
-
2026/09/18Accepted
株式会社富士薬品;上海瀚合瑞医药科技有限公司
JTH2600197
Fact date: 2026/09/18 · Site observation date: 2026/10/22
View source ↗ -
2026/09/17Accepted
-
2026/09/15Accepted
株式会社富士菜品;株式会社富士藁品;上海博悦生物科技有限公司
JTH2600193
Fact date: 2026/09/15 · Site observation date: 2026/10/22
View source ↗ -
2026/09/07Accepted
-
2026/09/07Accepted
-
2026/08/25Accepted
-
2026/08/25Accepted
-
2026/08/25Accepted
九华华源药业股份有限公司;华益药业科技(安徽)有限公司
CYHS2602113
Fact date: 2026/08/25 · Site observation date: 2026/10/22
View source ↗ -
2026/08/25Accepted
九华华源药业股份有限公司;华益药业科技（安徽）有限公司
CYHS2602112
Fact date: 2026/08/25 · Site observation date: 2026/10/22
View source ↗ -
2026/08/14Accepted
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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