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 1 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 |
|---|---|---|---|---|---|---|
| 江苏杜瑞制药有限公司 | 江苏杜瑞制药有限公司 | 国药准字H20203508 | 2020/09/30 | 10mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 江苏杜瑞制药有限公司 | 江苏杜瑞制药有限公司 | 国药准字H20203509 | 2020/09/30 | 50mg | 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 |
|---|---|---|---|---|---|
| 江苏杜瑞制药有限公司 | 国药准字H20203508 | 10mg | 乙 | XB01AXN121B001010110101 | NHSA |
| 江苏杜瑞制药有限公司 | 国药准字H20203509 | 50mg | 乙 | XB01AXN121B001010210101 | NHSA |
| 江苏杜瑞制药有限公司 | 国药准字H20203509 | 50mg | 乙 | XB01AXN121B001010310101 | NHSA |
| 江苏杜瑞制药有限公司 | 国药准字H20203508 | 10mg | 乙 | XB01AXN121B001020110101 | 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: 38 filings and 24 distinct first applicants.
Generic 38
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 海口市制药厂有限公司 | CYHS2602407 | Generic | 2026/09/24 | Not stated by source | CDE |
| 海口市制药厂有限公司 | CYHS2602406 | Generic | 2026/09/24 | Not stated by source | CDE |
| 武汉华龙生物制药有限公司 | CYHS2602272 | Generic | 2026/09/11 | Not stated by source | CDE |
| 河南欣泰药业有限公司 | CYHS2601885 | Generic | 2026/08/04 | Not stated by source | CDE |
| 河南欣泰药业有限公司 | CYHS2601884 | Generic | 2026/08/04 | Not stated by source | CDE |
| 成都赛诺联创生物科技有限公司;峨眉山通惠制药有限公司 | CYHS2601838 | Generic | 2026/07/30 | Not stated by source | CDE |
| 璟济生物医药科技（泰州）股份有限公司;江苏利泰尔药业有限公司 | CYHS2601772 | Generic | 2026/07/23 | Not stated by source | CDE |
| 福建大谱生物医药有限公司;武汉海特生物制药股份有限公司 | CYHS2601711 | Generic | 2026/07/17 | Not stated by source | CDE |
| 福安药业集团湖北人民制药有限公司 | CYHS2601594 | Generic | 2026/07/06 | Not stated by source | CDE |
| 福安药业集团湖北人民制药有限公司 | CYHS2601593 | Generic | 2026/07/06 | Not stated by source | CDE |
| 成都药宜立康医药科技有限公司;成都百裕制药股份有限公司 | CYHS2601592 | Generic | 2026/07/06 | Not stated by source | CDE |
| 天津红日药业股份有限公司;武汉人福药业有限责任公司 | CYHS2601589 | Generic | 2026/07/06 | Not stated by source | CDE |
| 康普药业股份有限公司 | CYHS2601580 | Generic | 2026/07/03 | Not stated by source | CDE |
| 康普药业股份有限公司 | CYHS2601579 | Generic | 2026/07/03 | Not stated by source | CDE |
| 成都青山利康药业股份有限公司;湖南科伦制药有限公司 | CYHS2601519 | Generic | 2026/06/29 | Not stated by source | CDE |
| 成都青山利康药业股份有限公司;湖南科伦制药有限公司 | CYHS2601518 | Generic | 2026/06/29 | Not stated by source | CDE |
| 广东健信制药股份有限公司 | CYHS2601505 | Generic | 2026/06/26 | Not stated by source | CDE |
| 广东健信制药股份有限公司 | CYHS2601504 | Generic | 2026/06/26 | Not stated by source | CDE |
| 重庆莱美药业股份有限公司 | CYHS2601499 | Generic | 2026/06/25 | Not stated by source | CDE |
| 浙江同伍生物医药有限公司;浙江亚太药业股份有限公司 | CYHS2601495 | Generic | 2026/06/25 | Not stated by source | CDE |
| 浙江同伍生物医药有限公司;浙江亚太药业股份有限公司 | CYHS2601494 | Generic | 2026/06/25 | Not stated by source | CDE |
| 广州瑞尔医药科技有限公司;广东隆赋药业股份有限公司 | CYHS2601470 | Generic | 2026/06/23 | Not stated by source | CDE |
| 广州瑞尔医药科技有限公司;广东隆赋药业股份有限公司 | CYHS2601469 | Generic | 2026/06/23 | Not stated by source | CDE |
| 北京赛升药业股份有限公司 | CYHS2601465 | Generic | 2026/06/23 | Not stated by source | CDE |
| 北京赛升药业股份有限公司 | CYHS2601464 | Generic | 2026/06/23 | Not stated by source | CDE |
| 山东百诺医药股份有限公司;吉林津升制药有限公司 | CYHS2601456 | Generic | 2026/06/18 | Not stated by source | CDE |
| 山东百诺医药股份有限公司;吉林津升制药有限公司 | CYHS2601455 | Generic | 2026/06/18 | Not stated by source | CDE |
| 湖南复瑞生物医药技术有限责任公司;湖南赛隆药业（长沙）有限公司 | CYHS2601443 | Generic | 2026/06/17 | Not stated by source | CDE |
| 湖南复瑞生物医药技术有限责任公司;湖南赛隆药业（长沙）有限公司 | CYHS2601442 | Generic | 2026/06/17 | Not stated by source | CDE |
| 成都苑东生物制药股份有限公司;成都通德药业有限公司 | CYHS2601408 | Generic | 2026/06/15 | Not stated by source | CDE |
| 重庆华邦制药有限公司 | CYHS2601406 | Generic | 2026/06/12 | Not stated by source | CDE |
| 重庆华邦制药有限公司 | CYHS2601405 | Generic | 2026/06/12 | Not stated by source | CDE |
| 南京正大天晴制药有限公司 | CYHS2601358 | Generic | 2026/06/10 | Not stated by source | CDE |
| 南京正大天晴制药有限公司 | CYHS2601357 | Generic | 2026/06/10 | Not stated by source | CDE |
| 湖南埃威格林医药科技有限公司;湖南赛隆药业（长沙）有限公司 | CYHS2601327 | Generic | 2026/06/08 | Not stated by source | CDE |
| 烟台东诚北方制药有限公司 | CYHS2601294 | Generic | 2026/06/04 | Not stated by source | CDE |
| 杭州沐源生物医药科技股份有限公司;湖南科伦制药有限公司 | CYHS2601042 | Generic | 2026/05/08 | Not stated by source | CDE |
| 杭州沐源生物医药科技股份有限公司;湖南科伦制药有限公司 | CYHS2601040 | Generic | 2026/05/08 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 41 filings and 24 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 海口市制药厂有限公司 | CYHS2602407 | Generic | 2026/09/24 | Not stated by source | CDE |
| 海口市制药厂有限公司 | CYHS2602406 | Generic | 2026/09/24 | Not stated by source | CDE |
| 武汉华龙生物制药有限公司 | CYHS2602272 | Generic | 2026/09/11 | Not stated by source | CDE |
| 河南欣泰药业有限公司 | CYHS2601885 | Generic | 2026/08/04 | Not stated by source | CDE |
| 河南欣泰药业有限公司 | CYHS2601884 | Generic | 2026/08/04 | Not stated by source | CDE |
| 成都赛诺联创生物科技有限公司;峨眉山通惠制药有限公司 | CYHS2601838 | Generic | 2026/07/30 | Not stated by source | CDE |
| 璟济生物医药科技（泰州）股份有限公司;江苏利泰尔药业有限公司 | CYHS2601772 | Generic | 2026/07/23 | Not stated by source | CDE |
| 福建大谱生物医药有限公司;武汉海特生物制药股份有限公司 | CYHS2601711 | Generic | 2026/07/17 | Not stated by source | CDE |
| 福安药业集团湖北人民制药有限公司 | CYHS2601594 | Generic | 2026/07/06 | Not stated by source | CDE |
| 福安药业集团湖北人民制药有限公司 | CYHS2601593 | Generic | 2026/07/06 | Not stated by source | CDE |
| 成都药宜立康医药科技有限公司;成都百裕制药股份有限公司 | CYHS2601592 | Generic | 2026/07/06 | Not stated by source | CDE |
| 天津红日药业股份有限公司;武汉人福药业有限责任公司 | CYHS2601589 | Generic | 2026/07/06 | Not stated by source | CDE |
| 康普药业股份有限公司 | CYHS2601580 | Generic | 2026/07/03 | Not stated by source | CDE |
| 康普药业股份有限公司 | CYHS2601579 | Generic | 2026/07/03 | Not stated by source | CDE |
| 成都青山利康药业股份有限公司;湖南科伦制药有限公司 | CYHS2601519 | Generic | 2026/06/29 | Not stated by source | CDE |
| 成都青山利康药业股份有限公司;湖南科伦制药有限公司 | CYHS2601518 | Generic | 2026/06/29 | Not stated by source | CDE |
| 广东健信制药股份有限公司 | CYHS2601505 | Generic | 2026/06/26 | Not stated by source | CDE |
| 广东健信制药股份有限公司 | CYHS2601504 | Generic | 2026/06/26 | Not stated by source | CDE |
| 重庆莱美药业股份有限公司 | CYHS2601499 | Generic | 2026/06/25 | Not stated by source | CDE |
| 浙江同伍生物医药有限公司;浙江亚太药业股份有限公司 | CYHS2601495 | Generic | 2026/06/25 | Not stated by source | CDE |
| 浙江同伍生物医药有限公司;浙江亚太药业股份有限公司 | CYHS2601494 | Generic | 2026/06/25 | Not stated by source | CDE |
| 广州瑞尔医药科技有限公司;广东隆赋药业股份有限公司 | CYHS2601470 | Generic | 2026/06/23 | Not stated by source | CDE |
| 广州瑞尔医药科技有限公司;广东隆赋药业股份有限公司 | CYHS2601469 | Generic | 2026/06/23 | Not stated by source | CDE |
| 北京赛升药业股份有限公司 | CYHS2601465 | Generic | 2026/06/23 | Not stated by source | CDE |
| 北京赛升药业股份有限公司 | CYHS2601464 | Generic | 2026/06/23 | Not stated by source | CDE |
| 山东百诺医药股份有限公司;吉林津升制药有限公司 | CYHS2601456 | Generic | 2026/06/18 | Not stated by source | CDE |
| 山东百诺医药股份有限公司;吉林津升制药有限公司 | CYHS2601455 | Generic | 2026/06/18 | Not stated by source | CDE |
| 湖南复瑞生物医药技术有限责任公司;湖南赛隆药业（长沙）有限公司 | CYHS2601443 | Generic | 2026/06/17 | Not stated by source | CDE |
| 湖南复瑞生物医药技术有限责任公司;湖南赛隆药业（长沙）有限公司 | CYHS2601442 | Generic | 2026/06/17 | Not stated by source | CDE |
| 成都苑东生物制药股份有限公司;成都通德药业有限公司 | CYHS2601408 | Generic | 2026/06/15 | Not stated by source | CDE |
| 重庆华邦制药有限公司 | CYHS2601406 | Generic | 2026/06/12 | Not stated by source | CDE |
| 重庆华邦制药有限公司 | CYHS2601405 | Generic | 2026/06/12 | Not stated by source | CDE |
| 南京正大天晴制药有限公司 | CYHS2601358 | Generic | 2026/06/10 | Not stated by source | CDE |
| 南京正大天晴制药有限公司 | CYHS2601357 | Generic | 2026/06/10 | Not stated by source | CDE |
| 湖南埃威格林医药科技有限公司;湖南赛隆药业（长沙）有限公司 | CYHS2601327 | Generic | 2026/06/08 | Not stated by source | CDE |
| 烟台东诚北方制药有限公司 | CYHS2601294 | Generic | 2026/06/04 | Not stated by source | CDE |
| 杭州沐源生物医药科技股份有限公司;湖南科伦制药有限公司 | CYHS2601042 | Generic | 2026/05/08 | Not stated by source | CDE |
| 杭州沐源生物医药科技股份有限公司;湖南科伦制药有限公司 | CYHS2601040 | Generic | 2026/05/08 | Not stated by source | CDE |
| 成都青山利康药业股份有限公司 | CYHL2600028 | Generic | 2026/02/25 | Not stated by source | CDE |
| 成都青山利康药业股份有限公司 | CYHL2600027 | Generic | 2026/02/25 | Not stated by source | CDE |
| 璟济生物医药科技（泰州）股份有限公司 | CYHL2600023 | Generic | 2026/02/11 | Not stated by source | CDE |
API registrations
Non-component matches: 9 companies with A status and 8 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 |
|---|---|---|---|---|---|---|
| 甲磺酸萘莫司他 | 福安药业集团宁波天衡制药有限公司 | Y20260000351 | I | Exact ingredient | 2026/04/30 | CDE |
| 甲磺酸萘莫司他 | 河南精康制药有限公司 | Y20260000256 | I | Exact ingredient | 2026/04/08 | CDE |
| 甲磺酸萘莫司他 | 安徽悦康凯悦制药有限公司 | Y20250001142 | I | Exact ingredient | 2025/11/28 | CDE |
| 甲磺酸萘莫司他 | 福建南方制药股份有限公司 | Y20250000687 | I | Exact ingredient | 2025/07/21 | CDE |
| 甲磺酸萘莫司他 | 内蒙古京东药业有限公司 | Y20250000677 | I | Exact ingredient | 2025/07/10 | CDE |
| 甲磺酸萘莫司他 | 宣城美诺华药业有限公司 | Y20250000463 | I | Exact ingredient | 2025/07/08 | CDE |
| 甲磺酸萘莫司他 | 河北广祥制药有限公司 | Y20250000314 | I | Exact ingredient | 2025/04/10 | CDE |
| 甲磺酸萘莫司他 | 重庆胜凯制药有限公司 | Y20250000318 | A | Exact ingredient | 2026/09/16 | CDE |
| 甲磺酸萘莫司他 | 四川青木制药有限公司 | Y20240001465 | A | Exact ingredient | 2026/03/30 | CDE |
| 甲磺酸萘莫司他 | 中瑞（内蒙古）药业股份有限公司 | Y20240001325 | I | Exact ingredient | 2026/03/12 | CDE |
| 甲磺酸萘莫司他 | 湖南复瑞生物医药技术有限责任公司 | Y20240000826 | A | Exact ingredient | 2026/06/02 | CDE |
| 甲磺酸萘莫司他 | 四川科伦药业股份有限公司 | Y20240000248 | A | Exact ingredient | 2025/09/30 | CDE |
| 甲磺酸萘莫司他 | 康普药业股份有限公司 | Y20230001395 | A | Exact ingredient | 2025/10/01 | CDE |
| 甲磺酸萘莫司他 | 兰州博晟康源药业有限公司 | Y20230001207 | A | Exact ingredient | 2026/08/07 | CDE |
| 甲磺酸萘莫司他 | Aurore Pharmaceuticals Private Limited | Y20230000142 | A | Exact ingredient | 2026/06/09 | CDE |
| 甲磺酸萘莫司他 | 山东朗诺制药有限公司 | Y20200001018 | A | Exact ingredient | 2024/06/28 | CDE |
| 甲磺酸萘莫司他 | 江苏杜瑞制药有限公司 | Y20170001582 | A | Exact ingredient | 2025/07/12 | 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.
-
2026/09/24Accepted
-
2026/09/24Accepted
-
2026/09/11Accepted
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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