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: 2 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 2 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 |
|---|---|---|---|---|---|---|
| 成都苑东生物制药股份有限公司 | 成都苑东生物制药股份有限公司 | 国药准字H20264691 | 2026/06/10 | 15mg（按C12H19NO2计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 南京正大天晴制药有限公司 | 南京正大天晴制药有限公司 | 国药准字H20263603 | 2026/03/17 | 5mg（按C12H19NO2计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 成都苑东生物制药股份有限公司 | 成都苑东生物制药股份有限公司 | 国药准字H20264689 | 2026/06/10 | 5mg（按C12H19NO2计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 成都苑东生物制药股份有限公司 | 成都苑东生物制药股份有限公司 | 国药准字H20264690 | 2026/06/10 | 10mg（按C12H19NO2计） | 按化学药品新注册分类批准的仿制药 | 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: 2 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| DAIICHI SANKYO CO.,LTD. | 国药准字HJ20240066 | 5mg(按C₁₂H₁₉NO₂计) | 乙 | XN02BFM187A001010179008 | NHSA |
| DAIICHI SANKYO CO.,LTD. | 国药准字HJ20240067 | 2.5mg(按C₁₂H₁₉NO₂计) | 乙 | XN02BFM187A001020179008 | 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: 58 filings and 31 distinct first applicants.
Generic 55 · Supplement 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东鲁抗医药股份有限公司 | CYHS2601398 | Generic | 2026/06/12 | Not stated by source | CDE |
| 山东鲁抗医药股份有限公司 | CYHS2601397 | Generic | 2026/06/12 | Not stated by source | CDE |
| 齐鲁制药（海南）有限公司 | CYHS2404045 | Generic | 2024/11/25 | Not stated by source | CDE |
| 齐鲁制药（海南）有限公司 | CYHS2404044 | Generic | 2024/11/25 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2602305 | Generic | 2026/09/16 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2602304 | Generic | 2026/09/16 | Not stated by source | CDE |
| 广东博卓医药科技有限公司;江苏润恒制药有限公司 | CYHS2601048 | Generic | 2026/05/08 | Not stated by source | CDE |
| 广东博卓医药科技有限公司;江苏润恒制药有限公司 | CYHS2601047 | Generic | 2026/05/08 | Not stated by source | CDE |
| 江苏联环药业股份有限公司 | CYHS2600198 | Generic | 2026/01/16 | Not stated by source | CDE |
| 江苏联环药业股份有限公司 | CYHS2600196 | Generic | 2026/01/16 | Not stated by source | CDE |
| 江苏联环药业股份有限公司 | CYHS2600195 | Generic | 2026/01/16 | Not stated by source | CDE |
| 江苏奥赛康药业有限公司 | CYHS2600111 | Generic | 2026/01/09 | Not stated by source | CDE |
| 江苏奥赛康药业有限公司 | CYHS2600109 | Generic | 2026/01/09 | Not stated by source | CDE |
| 南京万融健诚医药科技有限公司;江苏万禾制药有限公司 | CYHS2503023 | Generic | 2025/08/19 | Not stated by source | CDE |
| 福建东瑞制药有限公司 | CYHS2602540 | Generic | 2026/10/14 | Not stated by source | CDE |
| 福建东瑞制药有限公司 | CYHS2602539 | Generic | 2026/10/14 | Not stated by source | CDE |
| 北京福元医药股份有限公司 | CYHS2602195 | Generic | 2026/09/03 | Not stated by source | CDE |
| 北京福元医药股份有限公司 | CYHS2602194 | Generic | 2026/09/03 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2602105 | Generic | 2026/08/24 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2602104 | Generic | 2026/08/24 | Not stated by source | CDE |
| 宜昌人福药业有限责任公司 | CYHS2601981 | Generic | 2026/08/12 | Not stated by source | CDE |
| 中曦（福建）药业有限公司;药大制药有限公司 | CYHS2601912 | Generic | 2026/08/06 | Not stated by source | CDE |
| 中曦（福建）药业有限公司;药大制药有限公司 | CYHS2601911 | Generic | 2026/08/06 | Not stated by source | CDE |
| 山东丹红制药有限公司;山东步长制药股份有限公司 | CYHS2601844 | Generic | 2026/07/31 | Not stated by source | CDE |
| 山东丹红制药有限公司;山东步长制药股份有限公司 | CYHS2601843 | Generic | 2026/07/31 | Not stated by source | CDE |
| 广州誉东健康制药有限公司 | CYHB2601449 | Supplement | 2026/07/28 | Not stated by source | CDE |
| 湖南九典制药股份有限公司 | CYHS2601454 | Generic | 2026/06/18 | Not stated by source | CDE |
| 湖南九典制药股份有限公司 | CYHS2601453 | Generic | 2026/06/18 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2601386 | Generic | 2026/06/11 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2601385 | Generic | 2026/06/11 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2601383 | Generic | 2026/06/11 | Not stated by source | CDE |
| 江西山香药业有限公司 | CYHS2601326 | Generic | 2026/06/08 | Not stated by source | CDE |
| 湖南一格制药有限公司 | CYHS2601235 | Generic | 2026/06/01 | Not stated by source | CDE |
| 湖南一格制药有限公司 | CYHS2601234 | Generic | 2026/06/01 | Not stated by source | CDE |
| 九华华源药业（桂林）有限公司;华益药业科技（安徽）有限公司 | CYHS2600759 | Generic | 2026/04/01 | Not stated by source | CDE |
| 山东京卫制药有限公司 | CYHS2600742 | Generic | 2026/03/28 | Not stated by source | CDE |
| 山东京卫制药有限公司 | CYHS2600741 | Generic | 2026/03/28 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2600655 | Generic | 2026/03/13 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2600654 | Generic | 2026/03/13 | Not stated by source | CDE |
| 重庆华邦制药有限公司 | CYHS2600604 | Generic | 2026/02/28 | Not stated by source | CDE |
| 重庆华邦制药有限公司 | CYHS2600603 | Generic | 2026/02/28 | Not stated by source | CDE |
| 珠海同源药业有限公司;广州誉东健康制药有限公司 | CYHS2504364 | Generic | 2025/12/24 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2504287 | Generic | 2025/12/16 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2504286 | Generic | 2025/12/16 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2504285 | Generic | 2025/12/16 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2504284 | Generic | 2025/12/16 | Not stated by source | CDE |
| 九华华源药业（桂林）有限公司;华益药业科技（安徽）有限公司 | CYHS2504041 | Generic | 2025/11/22 | Not stated by source | CDE |
| DAIICHI SANKYO CO. LTD.;TAIYO Pharma Tech CO. LTD. Takatsuki Plant | JYHB2500524 | Supplement | 2025/10/14 | Not stated by source | CDE |
| DAIICHI SANKYO CO. LTD.;TAIYO Pharma Tech CO. LTD. Takatsuki Plant | JYHB2500523 | Supplement | 2025/10/14 | Not stated by source | CDE |
| 广州大光制药有限公司 | CYHS2503412 | Generic | 2025/09/16 | Not stated by source | CDE |
| 广州大光制药有限公司 | CYHS2503411 | Generic | 2025/09/16 | Not stated by source | CDE |
| 杭州和康药业有限公司 | CYHS2503060 | Generic | 2025/08/20 | Not stated by source | CDE |
| 杭州和康药业有限公司 | CYHS2503059 | Generic | 2025/08/20 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2502850 | Generic | 2025/08/06 | Not stated by source | CDE |
| 成都倍特药业股份有限公司 | CYHS2502650 | Generic | 2025/07/23 | Not stated by source | CDE |
| 成都倍特药业股份有限公司 | CYHS2502649 | Generic | 2025/07/23 | Not stated by source | CDE |
| 海南合瑞制药股份有限公司 | CYHS2502613 | Generic | 2025/07/19 | Not stated by source | CDE |
| 安徽泰恩康制药有限公司 | CYHS2602663 | Generic | 2026/10/30 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 38 filings and 20 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东鲁抗医药股份有限公司 | CYHS2601398 | Generic | 2026/06/12 | Not stated by source | CDE |
| 山东鲁抗医药股份有限公司 | CYHS2601397 | Generic | 2026/06/12 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2602305 | Generic | 2026/09/16 | Not stated by source | CDE |
| 南京海纳制药有限公司 | CYHS2602304 | Generic | 2026/09/16 | Not stated by source | CDE |
| 广东博卓医药科技有限公司;江苏润恒制药有限公司 | CYHS2601048 | Generic | 2026/05/08 | Not stated by source | CDE |
| 广东博卓医药科技有限公司;江苏润恒制药有限公司 | CYHS2601047 | Generic | 2026/05/08 | Not stated by source | CDE |
| 江苏联环药业股份有限公司 | CYHS2600198 | Generic | 2026/01/16 | Not stated by source | CDE |
| 江苏联环药业股份有限公司 | CYHS2600196 | Generic | 2026/01/16 | Not stated by source | CDE |
| 江苏联环药业股份有限公司 | CYHS2600195 | Generic | 2026/01/16 | Not stated by source | CDE |
| 江苏奥赛康药业有限公司 | CYHS2600111 | Generic | 2026/01/09 | Not stated by source | CDE |
| 江苏奥赛康药业有限公司 | CYHS2600109 | Generic | 2026/01/09 | Not stated by source | CDE |
| 福建东瑞制药有限公司 | CYHS2602540 | Generic | 2026/10/14 | Not stated by source | CDE |
| 福建东瑞制药有限公司 | CYHS2602539 | Generic | 2026/10/14 | Not stated by source | CDE |
| 北京福元医药股份有限公司 | CYHS2602195 | Generic | 2026/09/03 | Not stated by source | CDE |
| 北京福元医药股份有限公司 | CYHS2602194 | Generic | 2026/09/03 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2602105 | Generic | 2026/08/24 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2602104 | Generic | 2026/08/24 | Not stated by source | CDE |
| 宜昌人福药业有限责任公司 | CYHS2601981 | Generic | 2026/08/12 | Not stated by source | CDE |
| 中曦（福建）药业有限公司;药大制药有限公司 | CYHS2601912 | Generic | 2026/08/06 | Not stated by source | CDE |
| 中曦（福建）药业有限公司;药大制药有限公司 | CYHS2601911 | Generic | 2026/08/06 | Not stated by source | CDE |
| 山东丹红制药有限公司;山东步长制药股份有限公司 | CYHS2601844 | Generic | 2026/07/31 | Not stated by source | CDE |
| 山东丹红制药有限公司;山东步长制药股份有限公司 | CYHS2601843 | Generic | 2026/07/31 | Not stated by source | CDE |
| 湖南九典制药股份有限公司 | CYHS2601454 | Generic | 2026/06/18 | Not stated by source | CDE |
| 湖南九典制药股份有限公司 | CYHS2601453 | Generic | 2026/06/18 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2601386 | Generic | 2026/06/11 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2601385 | Generic | 2026/06/11 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2601383 | Generic | 2026/06/11 | Not stated by source | CDE |
| 江西山香药业有限公司 | CYHS2601326 | Generic | 2026/06/08 | Not stated by source | CDE |
| 湖南一格制药有限公司 | CYHS2601235 | Generic | 2026/06/01 | Not stated by source | CDE |
| 湖南一格制药有限公司 | CYHS2601234 | Generic | 2026/06/01 | Not stated by source | CDE |
| 九华华源药业（桂林）有限公司;华益药业科技（安徽）有限公司 | CYHS2600759 | Generic | 2026/04/01 | Not stated by source | CDE |
| 山东京卫制药有限公司 | CYHS2600742 | Generic | 2026/03/28 | Not stated by source | CDE |
| 山东京卫制药有限公司 | CYHS2600741 | Generic | 2026/03/28 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2600655 | Generic | 2026/03/13 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2600654 | Generic | 2026/03/13 | Not stated by source | CDE |
| 重庆华邦制药有限公司 | CYHS2600604 | Generic | 2026/02/28 | Not stated by source | CDE |
| 重庆华邦制药有限公司 | CYHS2600603 | Generic | 2026/02/28 | Not stated by source | CDE |
| 安徽泰恩康制药有限公司 | CYHS2602663 | Generic | 2026/10/30 | Not stated by source | CDE |
API registrations
Non-component matches: 5 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 |
|---|---|---|---|---|---|---|
| 苯磺酸美洛加巴林 | 浙江竹子制药有限公司 | Y20260000794 | I | Exact ingredient | 2026/10/16 | CDE |
| 苯磺酸美洛加巴林 | 珠海海瑞德制药有限公司 | Y20260000652 | I | Exact ingredient | 2026/07/30 | CDE |
| 苯磺酸美洛加巴林 | 浙江车头制药股份有限公司 | Y20260000588 | I | Exact ingredient | 2026/07/22 | CDE |
| 苯磺酸美洛加巴林 | 山东新时代药业有限公司 | Y20260000286 | I | Exact ingredient | 2026/04/22 | CDE |
| 苯磺酸美洛加巴林 | 石家庄龙泽制药股份有限公司 | Y20260000129 | I | Exact ingredient | 2026/03/23 | CDE |
| 苯磺酸美洛加巴林 | 浙江赛默制药有限公司 | Y20240001488 | I | Exact ingredient | 2026/03/09 | CDE |
| 苯磺酸美洛加巴林 | 天方药业有限公司 | Y20260000097 | I | Exact ingredient | 2026/02/09 | CDE |
| 苯磺酸美洛加巴林 | 重庆胜凯制药有限公司 | Y20260000082 | I | Exact ingredient | 2026/02/03 | CDE |
| 苯磺酸美洛加巴林 | 浙江华海建诚药业有限公司 | Y20250001358 | I | Exact ingredient | 2025/12/17 | CDE |
| 苯磺酸美洛加巴林 | 山东龙辰药业有限公司 | Y20250001242 | I | Exact ingredient | 2025/12/11 | CDE |
| 苯磺酸美洛加巴林 | 汉瑞药业（荆门）有限公司 | Y20250001290 | I | Exact ingredient | 2025/12/09 | CDE |
| 苯磺酸美洛加巴林 | 浙江京圣药业有限公司 | Y20250001280 | I | Exact ingredient | 2025/12/08 | CDE |
| 苯磺酸美洛加巴林 | 烟台万润药业有限公司 | Y20250001223 | I | Exact ingredient | 2025/11/24 | CDE |
| 苯磺酸美洛加巴林 | 四川科伦药业股份有限公司 | Y20250000830 | I | Exact ingredient | 2025/09/19 | CDE |
| 苯磺酸美洛加巴林 | 安徽云帆药业有限公司 | Y20250000204 | I | Exact ingredient | 2025/09/05 | CDE |
| 苯磺酸美洛加巴林 | 山东锐顺药业有限公司 | Y20250000700 | I | Exact ingredient | 2025/07/17 | CDE |
| 苯磺酸美洛加巴林 | 湖北天舒药业有限公司 | Y20250000629 | I | Exact ingredient | 2025/07/03 | CDE |
| 苯磺酸美洛加巴林 | 福建南方制药股份有限公司 | Y20250000472 | I | Exact ingredient | 2025/05/29 | CDE |
| 苯磺酸美洛加巴林 | 苏州正济药业有限公司 | Y20250000388 | I | Exact ingredient | 2025/05/08 | CDE |
| 苯磺酸美洛加巴林 | 四川青木制药有限公司 | Y20240001363 | A | Exact ingredient | 2026/05/06 | CDE |
| 苯磺酸美洛加巴林 | 甘肃皓天医药科技有限责任公司 | Y20240000972 | A | Exact ingredient | 2026/06/24 | CDE |
| 苯磺酸美洛加巴林 | 山东安弘制药有限公司 | Y20240000736 | A | Exact ingredient | 2026/01/05 | CDE |
| 苯磺酸美洛加巴林 | 四川仁安药业有限责任公司 | Y20240000721 | A | Exact ingredient | 2026/02/25 | CDE |
| 苯磺酸美洛加巴林 | 宣城美诺华药业有限公司 | Y20240000689 | A | Exact ingredient | 2026/03/25 | 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.
-
2026/10/30Accepted
-
2026/10/14Accepted
-
2026/10/14Accepted
-
2026/09/16Accepted
-
2026/09/16Accepted
-
2026/09/03Accepted
-
2026/09/03Accepted
-
2026/08/24Accepted
-
2026/08/24Accepted
-
2026/08/12Accepted
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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Ongoing tracking for selected drugs
¥2,400/ year · pilot price
- A competitive ledger for up to 10 drugs, updated with daily data and available historical comparisons.
- Collected changes routed to designated responsible roles with the daily scheduled send.
- A forwardable weekly project-change digest, with sources for each record.
- Source dates and coverage gaps shown when collection is incomplete.
This form records an activation request; it does not charge or activate a subscription. History begins with records actually accumulated by this site. Scope is confirmed before activation.