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: 8 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 8 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 |
|---|---|---|---|---|---|---|
| 石药集团中诺药业（石家庄）有限公司 | 石药集团中诺药业（石家庄）有限公司 | 国药准字H20265705 | 2026/08/25 | 15mg（按C17H19F3N6O计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 山东齐都药业有限公司 | 山东齐都药业有限公司 | 国药准字H20265479 | 2026/08/04 | 15mg（按C17H19F3N6O计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 华益泰康药业股份有限公司 | 华益泰康药业股份有限公司 | 国药准字H20265230 | 2026/07/21 | 15mg（按C17H19F3N6O计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 上海信谊百路达药业有限公司 | 上海信谊百路达药业有限公司 | 国药准字H20265099 | 2026/07/08 | 15 mg（按C17H19F3N6O 计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 浙江花园药业有限公司 | 浙江花园药业有限公司 | 国药准字H20264996 | 2026/06/30 | 15mg（按C17H19F3N6O计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 江苏飞马药业有限公司 | 江苏飞马药业有限公司 | 国药准字H20264361 | 2026/05/19 | 15mg（按C17H19F3N6O计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 重庆华邦制药有限公司 | 重庆华邦制药有限公司 | 国药准字H20264176 | 2026/04/29 | 15mg（按C17H19F3N6O计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 江苏华阳制药有限公司 | 江苏华阳制药有限公司 | 国药准字H20264136 | 2026/04/21 | 15mg（按C17H19F3N6O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: 3 distinct approval numbers and 2 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| AbbVie Deutschland GmbH & Co. KG | 国药准字HJ20220010 | 15mg(按C17H19F3N6O计) | 乙 | XL04AAW126A010010182925 | NHSA |
| AbbVie Deutschland GmbH & Co. KG | 国药准字HJ20220010 | 15mg(按C17H19F3N6O计) | 乙 | XL04AAW126A010010282925 | NHSA |
| AbbVie Deutschland GmbH & Co. KG | 国药准字HJ20220011 | 30mg(按C17H19F3N6O计) | 乙 | XL04AAW126A010020182925 | NHSA |
| AbbVie Deutschland GmbH & Co. KG | 国药准字HJ20220011 | 30mg(按C17H19F3N6O计) | 乙 | XL04AAW126A010020282925 | NHSA |
| Abbvie Deutschland GmbH&Co.KG | 国药准字HJ20233125 | 45mg(按C17H19F3N6O计) | 乙 | XL04AFW126A010010182925 | NHSA |
| Abbvie Deutschland GmbH&Co.KG | 国药准字HJ20233125 | 45mg(按C17H19F3N6O计) | 乙 | XL04AFW126A010010282925 | 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: 43 filings and 39 distinct first applicants.
Generic 37 · Import 3 · Import re-registration 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 烟台鲁银药业有限公司 | CYHS2600342 | Generic | 2026/02/03 | Not stated by source | CDE |
| 山东济坤生物制药有限公司;山东鲁抗三叶制药有限公司 | CYHS2601493 | Generic | 2026/06/25 | Not stated by source | CDE |
| 齐鲁制药（海南）有限公司 | CYHS2504442 | Generic | 2025/12/26 | Not stated by source | CDE |
| 江苏万高药业股份有限公司 | CYHS2504513 | Generic | 2025/12/31 | Not stated by source | CDE |
| 江苏和晨药业有限公司 | CYHS2504433 | Generic | 2025/12/26 | Not stated by source | CDE |
| 复星万邦（江苏）医药集团有限公司 | CYHS2501221 | Generic | 2025/03/28 | Not stated by source | CDE |
| 安徽万邦医药科技股份有限公司;扬子江药业集团江苏紫龙药业有限公司 | CYHS2600962 | Generic | 2026/04/25 | Not stated by source | CDE |
| 南通联亚药业股份有限公司 | CYHS2600004 | Generic | 2026/01/04 | Not stated by source | CDE |
| 江苏亚邦爱普森药业有限公司 | CYHS2502604 | Generic | 2025/07/19 | Not stated by source | CDE |
| 北大医药股份有限公司 | CYHS2602299 | Generic | 2026/09/16 | Not stated by source | CDE |
| AbbVie Inc.;AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. | JXHL2600400 | Import | 2026/09/11 | Not stated by source | CDE |
| AbbVie Deutschland GmbH & Co. KG;AbbVie Ireland NL B.V. | JXHS2600101 | Import | 2026/08/25 | Not stated by source | CDE |
| AbbVie Deutschland GmbH & Co. KG;AbbVie Ireland NL B.V. | JXHS2600100 | Import | 2026/08/24 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2601947 | Generic | 2026/08/10 | Not stated by source | CDE |
| AbbVie Deutschland GmbH & Co. KG;AbbVie Ireland NL B.V.;AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd | JYHZ2600184 | Import re-registration | 2026/07/31 | Not stated by source | CDE |
| AbbVie Deutschland GmbH & Co. KG;AbbVie Ireland NL B.V.;AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd | JYHZ2600183 | Import re-registration | 2026/07/31 | Not stated by source | CDE |
| AbbVie Deutschland GmbH & Co. KG;AbbVie Ireland NL B.V.;AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd | JYHZ2600182 | Import re-registration | 2026/07/31 | Not stated by source | CDE |
| 海南合瑞制药股份有限公司 | CYHS2601776 | Generic | 2026/07/24 | Not stated by source | CDE |
| 上海上药中西制药有限公司 | CYHS2601416 | Generic | 2026/06/15 | Not stated by source | CDE |
| 濮阳市汇元药业有限公司 | CYHS2601404 | Generic | 2026/06/12 | Not stated by source | CDE |
| 江西泰吉立生物制药有限公司 | CYHS2601186 | Generic | 2026/05/20 | 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 | CYHS2601096 | Generic | 2026/05/13 | Not stated by source | CDE |
| 山东明仁福瑞达制药股份有限公司 | CYHS2601095 | Generic | 2026/05/13 | Not stated by source | CDE |
| 山东裕欣药业有限公司 | CYHS2600807 | Generic | 2026/04/09 | Not stated by source | CDE |
| 石家庄四药有限公司 | CYHS2600226 | Generic | 2026/01/20 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2600063 | Generic | 2026/01/07 | Not stated by source | CDE |
| 浙江昂利康制药股份有限公司 | CYHS2504480 | Generic | 2025/12/30 | Not stated by source | CDE |
| 山东百诺医药股份有限公司;吉林四环制药有限公司 | CYHS2504441 | Generic | 2025/12/27 | Not stated by source | CDE |
| 辽宁鑫善源药业有限公司 | CYHS2504368 | Generic | 2025/12/24 | Not stated by source | CDE |
| 天津红日药业股份有限公司 | CYHS2504198 | Generic | 2025/12/06 | 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 | CYHS2504028 | Generic | 2025/11/21 | Not stated by source | CDE |
| 平光制药股份有限公司 | CYHS2503365 | Generic | 2025/09/11 | Not stated by source | CDE |
| 合肥英太制药有限公司 | CYHS2503067 | Generic | 2025/08/21 | Not stated by source | CDE |
| 西洲医药科技（浙江）有限公司;浙江北生药业汉生制药有限公司 | CYHS2502795 | Generic | 2025/08/02 | Not stated by source | CDE |
| 广州誉东健康制药有限公司 | CYHS2502579 | Generic | 2025/07/18 | Not stated by source | CDE |
| 重庆圣华曦药业股份有限公司 | CYHS2502203 | Generic | 2025/06/19 | Not stated by source | CDE |
| 北京北陆药业股份有限公司;湖州亚瑟制药有限公司 | CYHS2502132 | Generic | 2025/06/14 | Not stated by source | CDE |
| 山东诺禾康药业有限公司 | CYHS2502111 | Generic | 2025/06/12 | Not stated by source | CDE |
| 杨凌科森生物制药有限责任公司 | CYHS2403496 | Generic | 2024/10/16 | Not stated by source | CDE |
| 四川国为制药有限公司 | CYHS2400271 | Generic | 2024/01/19 | Not stated by source | CDE |
| 天地恒一制药股份有限公司 | CYHS2400083 | Generic | 2024/01/06 | Not stated by source | CDE |
| 黑龙江福和制药集团股份有限公司 | CYHS2602622 | Generic | 2026/10/26 | Not stated by source | CDE |
| 中山百灵生物技术股份有限公司;广州绿十字制药股份有限公司 | CYHS2602676 | Generic | 2026/11/02 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 18 filings and 18 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 烟台鲁银药业有限公司 | CYHS2600342 | Generic | 2026/02/03 | Not stated by source | CDE |
| 山东济坤生物制药有限公司;山东鲁抗三叶制药有限公司 | CYHS2601493 | Generic | 2026/06/25 | Not stated by source | CDE |
| 安徽万邦医药科技股份有限公司;扬子江药业集团江苏紫龙药业有限公司 | CYHS2600962 | Generic | 2026/04/25 | Not stated by source | CDE |
| 南通联亚药业股份有限公司 | CYHS2600004 | Generic | 2026/01/04 | Not stated by source | CDE |
| 北大医药股份有限公司 | CYHS2602299 | Generic | 2026/09/16 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2601947 | Generic | 2026/08/10 | Not stated by source | CDE |
| 珠海健福制药有限公司 | CYHS2601920 | Generic | 2026/08/06 | Not stated by source | CDE |
| 海南合瑞制药股份有限公司 | CYHS2601776 | Generic | 2026/07/24 | Not stated by source | CDE |
| 上海上药中西制药有限公司 | CYHS2601416 | Generic | 2026/06/15 | Not stated by source | CDE |
| 濮阳市汇元药业有限公司 | CYHS2601404 | Generic | 2026/06/12 | Not stated by source | CDE |
| 江西泰吉立生物制药有限公司 | CYHS2601186 | Generic | 2026/05/20 | 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 | CYHS2601096 | Generic | 2026/05/13 | Not stated by source | CDE |
| 山东明仁福瑞达制药股份有限公司 | CYHS2601095 | Generic | 2026/05/13 | Not stated by source | CDE |
| 山东裕欣药业有限公司 | CYHS2600807 | Generic | 2026/04/09 | Not stated by source | CDE |
| 石家庄四药有限公司 | CYHS2600226 | Generic | 2026/01/20 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2600063 | Generic | 2026/01/07 | Not stated by source | CDE |
| 黑龙江福和制药集团股份有限公司 | CYHS2602622 | Generic | 2026/10/26 | Not stated by source | CDE |
| 中山百灵生物技术股份有限公司;广州绿十字制药股份有限公司 | CYHS2602676 | Generic | 2026/11/02 | Not stated by source | CDE |
API registrations
Non-component matches: 8 companies with A status and 21 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 |
|---|---|---|---|---|---|---|
| 乌帕替尼 | 潍坊市海欣药业有限公司 | Y20260000714 | I | Exact ingredient | 2026/10/09 | CDE |
| 乌帕替尼 | 浙江普洛康裕制药有限公司 | Y20260000726 | I | Exact ingredient | 2026/09/03 | CDE |
| 乌帕替尼 | 重庆胜凯制药有限公司 | Y20260000630 | I | Exact ingredient | 2026/08/14 | CDE |
| 乌帕替尼 | 烟台万润药业有限公司 | Y20260000624 | I | Exact ingredient | 2026/08/11 | CDE |
| 乌帕替尼 | 黑龙江福和制药集团股份有限公司 | Y20260000181 | I | Exact ingredient | 2026/06/10 | CDE |
| 乌帕替尼 | 山东济坤生物制药有限公司 | Y20260000007 | I | Exact ingredient | 2026/04/16 | CDE |
| 乌帕替尼 | 山东海佑福瑞达制药有限公司 | Y20260000183 | I | Exact ingredient | 2026/04/10 | CDE |
| 乌帕替尼 | 江苏天士力帝益药业有限公司 | Y20250001484 | I | Exact ingredient | 2026/02/14 | CDE |
| 乌帕替尼 | 重庆瑞泊莱制药有限公司 | Y20250001461 | I | Exact ingredient | 2026/01/20 | CDE |
| 乌帕替尼 | 甘肃皓天医药科技有限责任公司 | Y20250001420 | I | Exact ingredient | 2026/01/07 | CDE |
| 乌帕替尼 | 四川普康药业有限公司 | Y20250001414 | I | Exact ingredient | 2025/12/29 | CDE |
| 乌帕替尼 | 北京北陆药业股份有限公司 | Y20250001383 | I | Exact ingredient | 2025/12/25 | CDE |
| 乌帕替尼 | 山东罗欣药业集团恒欣药业有限公司 | Y20250001329 | I | Exact ingredient | 2025/12/17 | CDE |
| 乌帕替尼 | 山东安弘制药有限公司 | Y20250001213 | I | Exact ingredient | 2025/11/21 | CDE |
| 乌帕替尼 | 上海迪赛诺化学制药有限公司 | Y20250001177 | I | Exact ingredient | 2025/11/18 | CDE |
| 乌帕替尼 | 浙江恒康药业股份有限公司 | Y20250000984 | I | Exact ingredient | 2025/09/29 | CDE |
| 乌帕替尼 | 山东诚汇双达药业有限公司 | Y20250000947 | I | Exact ingredient | 2025/09/08 | CDE |
| 乌帕替尼 | 潍坊市海欣药业有限公司 | Y20250000849 | I | Exact ingredient | 2025/08/18 | CDE |
| 乌帕替尼 | 湖北天舒药业有限公司 | Y20250000768 | I | Exact ingredient | 2025/08/08 | CDE |
| 乌帕替尼 | 山东齐都药业有限公司 | Y20250000616 | I | Exact ingredient | 2025/07/09 | CDE |
| 乌帕替尼 | 重庆圣华曦药业股份有限公司 | Y20250000509 | I | Exact ingredient | 2025/06/03 | CDE |
| 乌帕替尼 | 万洋衡水制药有限公司 | Y20250000199 | A | Exact ingredient | 2026/10/21 | CDE |
| 乌帕替尼 | 湖北天舒药业有限公司 | Y20250000234 | A | Exact ingredient | 2026/09/29 | CDE |
| 乌帕替尼 | 南通常佑药业科技有限公司 | Y20250000068 | A | Exact ingredient | 2026/08/21 | CDE |
| 乌帕替尼 | 南通常佑药业科技有限公司 | Y20240001377 | A | Exact ingredient | 2026/08/21 | CDE |
| 乌帕替尼 | 徐州万邦金桥制药有限公司 | Y20240001538 | A | Exact ingredient | 2026/06/11 | CDE |
| 乌帕替尼 | 天地恒一制药股份有限公司 | Y20240001316 | A | Exact ingredient | 2026/06/23 | CDE |
| 乌帕替尼 | 河北国龙制药有限公司 | Y20240001109 | A | Exact ingredient | 2026/08/12 | CDE |
| 乌帕替尼 | 浙江华海药业股份有限公司 | Y20240000970 | A | Exact ingredient | 2026/04/03 | CDE |
| 乌帕替尼 | 四川国为制药有限公司 | Y20230001341 | A | Exact ingredient | 2025/03/19 | CDE |
| 乌帕替尼 | 天地恒一制药股份有限公司 | Y20230000796 | A | Exact ingredient | 2026/06/23 | 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.
-
2026/11/02Accepted
中山百灵生物技术股份有限公司;广州绿十字制药股份有限公司
CYHS2602676
Fact date: 2026/11/02 · Site observation date: 2026/11/03
View source ↗ -
2026/10/28No longer listed under review
AbbVie Deutschland GmbH & Co. KG;AbbVie Ireland NL B.V.
JXHS2600042
Fact date: 2026/10/28 · Site observation date: 2026/10/28
Accepted: 2026/04/21
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/28No longer listed under review
珠海健福制药有限公司
CYHS2601920
Fact date: 2026/10/28 · Site observation date: 2026/10/28
Accepted: 2026/08/06
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/26Marketing application approved
广东华润顺峰药业有限公司
CYHS2501912 · 国药准字H20266398
Fact date: 2026/10/26 · Publication date: 2026/10/27 · Site observation date: 2026/11/03
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval. NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/05 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
View source · Table row 49 ↗ -
2026/10/26Accepted
-
2026/10/20Marketing application approved
湖南千金湘江药业股份有限公司
CYHS2502309 · 国药准字H20266357
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval. NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/05 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
View source · Table row 75 ↗ -
2026/09/16Accepted
-
2026/09/11Accepted
AbbVie Inc.;AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
JXHL2600400
Fact date: 2026/09/11 · Site observation date: 2026/10/22
View source ↗ -
2026/08/25Accepted
AbbVie Deutschland GmbH & Co. KG;AbbVie Ireland NL B.V.
JXHS2600101
Fact date: 2026/08/25 · Site observation date: 2026/10/22
View source ↗ -
2026/08/24Accepted
AbbVie Deutschland GmbH & Co. KG;AbbVie Ireland NL B.V.
JXHS2600100
Fact date: 2026/08/24 · Site observation date: 2026/10/22
View source ↗ -
2026/08/10Accepted
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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- 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.