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 |
|---|---|---|---|---|---|---|
| 广州绿十字制药股份有限公司 | 广州绿十字制药股份有限公司 | 国药准字H20264889 | 2026/06/17 | 2mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 广州绿十字制药股份有限公司 | 广州绿十字制药股份有限公司 | 国药准字H20264888 | 2026/06/17 | 4mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 江苏德源药业股份有限公司 | 江苏德源药业股份有限公司 | 国药准字H20264245 | 2026/05/07 | 2mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 湖南千金湘江药业股份有限公司 | 杭州朱养心药业有限公司 | 国药准字H20256432 | 2025/12/30 | 4mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 湖南千金湘江药业股份有限公司 | 杭州朱养心药业有限公司 | 国药准字H20256433 | 2025/12/30 | 2mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 复星万邦（江苏）医药集团有限公司 | 复星万邦（江苏）医药集团有限公司 | 国药准字H20256318 | 2025/12/16 | 2mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 复星万邦（江苏）医药集团有限公司 | 复星万邦（江苏）医药集团有限公司 | 国药准字H20256317 | 2025/12/16 | 4mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 山东华铂凯盛生物科技有限公司 | 安徽泰恩康制药有限公司 | 国药准字H20256060 | 2025/11/25 | 2mg（按C16H17N7O2S计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 南京海纳制药有限公司 | 南京海纳制药有限公司 | 国药准字H20255895 | 2025/11/12 | 2mg（按C16H17N7O2S计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 杭州民生药业股份有限公司 | 杭州民生药业股份有限公司 | 国药准字H20255470 | 2025/09/09 | 2mg（按C16H17N7O2S计） | 按化学药品新注册分类批准的仿制药 | CDE |
| 南京力博维制药有限公司 | 南京优科制药有限公司 | 国药准字H20234188 | 2023/09/28 | 2mg | 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: 13 distinct approval numbers and 9 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 广州绿十字制药股份有限公司 | 国药准字H20264888 | 4mg | 乙 | XL04AAB233A001010100475 | NHSA |
| 复星万邦(江苏)医药集团有限公司 | 国药准字H20256317 | 4mg | 乙 | XL04AAB233A001010101729 | NHSA |
| 杭州民生药业股份有限公司 | 国药准字H20255470 | 2mg(按C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010104494 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20256433 | 2mg | 乙 | XL04AAB233A001010104960 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20264245 | 2mg | 乙 | XL04AAB233A001010106632 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20190039 | 2mg(以C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010178403 | NHSA |
| 南京海纳制药有限公司 | 国药准字H20255895 | 2mg(按C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010180537 | NHSA |
| 南京力博维制药有限公司 | 国药准字H20234188 | 2mg | 乙 | XL04AAB233A001010180542 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20256060 | 2mg(按C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010183034 | NHSA |
| 复星万邦(江苏)医药集团有限公司 | 国药准字H20256317 | 4mg | 乙 | XL04AAB233A001010201729 | NHSA |
| 杭州民生药业股份有限公司 | 国药准字H20255470 | 2mg(按C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010204494 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20256433 | 2mg | 乙 | XL04AAB233A001010204960 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20264245 | 2mg | 乙 | XL04AAB233A001010206632 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20190039 | 2mg(以C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010278403 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20256060 | 2mg(按C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010283034 | NHSA |
| 复星万邦(江苏)医药集团有限公司 | 国药准字H20256317 | 4mg | 乙 | XL04AAB233A001010301729 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20264245 | 2mg | 乙 | XL04AAB233A001010306632 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20190039 | 2mg(以C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010378403 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20256060 | 2mg(按C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010383034 | NHSA |
| 复星万邦(江苏)医药集团有限公司 | 国药准字H20256317 | 4mg | 乙 | XL04AAB233A001010401729 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20264245 | 2mg | 乙 | XL04AAB233A001010406632 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20190039 | 2mg(以C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010478403 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20256060 | 2mg(按C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010483034 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20264245 | 2mg | 乙 | XL04AAB233A001010506632 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20256060 | 2mg(按C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010583034 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20264245 | 2mg | 乙 | XL04AAB233A001010606632 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20256060 | 2mg(按C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010683034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20256060 | 2mg(按C₁₆H₁₇N₇O₂S计) | 乙 | XL04AAB233A001010783034 | NHSA |
| 广州绿十字制药股份有限公司 | 国药准字H20264889 | 2mg | 乙 | XL04AAB233A001020100475 | NHSA |
| 复星万邦(江苏)医药集团有限公司 | 国药准字H20256318 | 2mg | 乙 | XL04AAB233A001020101729 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20256432 | 4mg | 乙 | XL04AAB233A001020104960 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20215001 | 4mg(以C16H17N7O2S计) | 乙 | XL04AAB233A001020178403 | NHSA |
| 复星万邦(江苏)医药集团有限公司 | 国药准字H20256318 | 2mg | 乙 | XL04AAB233A001020201729 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20256432 | 4mg | 乙 | XL04AAB233A001020204960 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20215001 | 4mg(以C16H17N7O2S计) | 乙 | XL04AAB233A001020278403 | NHSA |
| 复星万邦(江苏)医药集团有限公司 | 国药准字H20256318 | 2mg | 乙 | XL04AAB233A001020301729 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20215001 | 4mg(以C16H17N7O2S计) | 乙 | XL04AAB233A001020378403 | NHSA |
| 复星万邦(江苏)医药集团有限公司 | 国药准字H20256318 | 2mg | 乙 | XL04AAB233A001020401729 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20215001 | 4mg(以C16H17N7O2S计) | 乙 | XL04AAB233A001020478403 | 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: 32 filings and 23 distinct first applicants.
Generic 30 · Import 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏万高药业股份有限公司 | CYHS2502940 | Generic | 2025/08/13 | Not stated by source | CDE |
| 江苏万高药业股份有限公司 | CYHS2502939 | Generic | 2025/08/13 | Not stated by source | CDE |
| 山东鲁抗医药集团赛特有限责任公司;江苏华阳制药有限公司 | CYHS2502558 | Generic | 2025/07/16 | Not stated by source | CDE |
| 湖北民康制药有限公司;南京海纳制药有限公司 | CYHS2602396 | Generic | 2026/09/23 | Not stated by source | CDE |
| 湖北民康制药有限公司;南京海纳制药有限公司 | CYHS2602395 | Generic | 2026/09/23 | Not stated by source | CDE |
| 南京正科医药股份有限公司 | CYHS2504312 | Generic | 2025/12/19 | Not stated by source | CDE |
| 江苏神华药业有限公司 | CYHS2601782 | Generic | 2026/07/24 | Not stated by source | CDE |
| 山东良福制药有限公司 | CYHS2602588 | Generic | 2026/10/21 | Not stated by source | CDE |
| 四川新斯顿制药股份有限公司 | CYHS2602386 | Generic | 2026/09/22 | Not stated by source | CDE |
| 上海上药中西制药有限公司 | CYHS2602021 | Generic | 2026/08/14 | Not stated by source | CDE |
| 安徽贝克生物制药有限公司 | CYHS2601730 | Generic | 2026/07/20 | Not stated by source | CDE |
| 安徽贝克生物制药有限公司 | CYHS2601729 | Generic | 2026/07/20 | Not stated by source | CDE |
| 辰欣药业股份有限公司 | CYHS2601701 | Generic | 2026/07/16 | Not stated by source | CDE |
| 辰欣药业股份有限公司 | CYHS2601700 | Generic | 2026/07/16 | Not stated by source | CDE |
| 广州大光制药有限公司 | CYHS2601466 | Generic | 2026/06/23 | Not stated by source | CDE |
| 山东百诺医药股份有限公司;东吴制药（山东）有限公司 | CYHS2601102 | Generic | 2026/05/13 | Not stated by source | CDE |
| 山东百诺医药股份有限公司;东吴制药（山东）有限公司 | CYHS2601101 | Generic | 2026/05/13 | Not stated by source | CDE |
| 安徽泰恩康制药有限公司 | CYHS2600935 | Generic | 2026/04/23 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2600723 | Generic | 2026/03/26 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2600722 | Generic | 2026/03/26 | Not stated by source | CDE |
| MSN LABORATORIES PRIVATE LIMITED | JYHS2600005 | Import | 2026/03/02 | Not stated by source | CDE |
| MSN LABORATORIES PRIVATE LIMITED | JYHS2600004 | Import | 2026/03/02 | Not stated by source | CDE |
| 江西迪赛诺医药集团有限公司 | CYHS2600566 | Generic | 2026/02/27 | Not stated by source | CDE |
| 浙江东亚药业股份有限公司 | CYHS2600397 | Generic | 2026/02/06 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2600139 | Generic | 2026/01/10 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2600138 | Generic | 2026/01/10 | Not stated by source | CDE |
| 北京福元医药股份有限公司 | CYHS2600012 | Generic | 2026/01/05 | Not stated by source | CDE |
| 海南海灵化学制药有限公司 | CYHS2504339 | Generic | 2025/12/22 | Not stated by source | CDE |
| 海南海灵化学制药有限公司 | CYHS2504338 | Generic | 2025/12/22 | Not stated by source | CDE |
| 天地恒一制药股份有限公司 | CYHS2503843 | Generic | 2025/10/31 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2502962 | Generic | 2025/08/13 | Not stated by source | CDE |
| 海化生命（厦门）科技有限公司;华益泰康药业股份有限公司 | CYHS2502477 | Generic | 2025/07/11 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 21 filings and 15 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 湖北民康制药有限公司;南京海纳制药有限公司 | CYHS2602396 | Generic | 2026/09/23 | Not stated by source | CDE |
| 湖北民康制药有限公司;南京海纳制药有限公司 | CYHS2602395 | Generic | 2026/09/23 | Not stated by source | CDE |
| 江苏神华药业有限公司 | CYHS2601782 | Generic | 2026/07/24 | Not stated by source | CDE |
| 山东良福制药有限公司 | CYHS2602588 | Generic | 2026/10/21 | Not stated by source | CDE |
| 四川新斯顿制药股份有限公司 | CYHS2602386 | Generic | 2026/09/22 | Not stated by source | CDE |
| 上海上药中西制药有限公司 | CYHS2602021 | Generic | 2026/08/14 | Not stated by source | CDE |
| 安徽贝克生物制药有限公司 | CYHS2601730 | Generic | 2026/07/20 | Not stated by source | CDE |
| 安徽贝克生物制药有限公司 | CYHS2601729 | Generic | 2026/07/20 | Not stated by source | CDE |
| 辰欣药业股份有限公司 | CYHS2601701 | Generic | 2026/07/16 | Not stated by source | CDE |
| 辰欣药业股份有限公司 | CYHS2601700 | Generic | 2026/07/16 | Not stated by source | CDE |
| 广州大光制药有限公司 | CYHS2601466 | Generic | 2026/06/23 | Not stated by source | CDE |
| 山东百诺医药股份有限公司;东吴制药（山东）有限公司 | CYHS2601102 | Generic | 2026/05/13 | Not stated by source | CDE |
| 山东百诺医药股份有限公司;东吴制药（山东）有限公司 | CYHS2601101 | Generic | 2026/05/13 | Not stated by source | CDE |
| 安徽泰恩康制药有限公司 | CYHS2600935 | Generic | 2026/04/23 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2600723 | Generic | 2026/03/26 | Not stated by source | CDE |
| 山东朗诺制药有限公司 | CYHS2600722 | Generic | 2026/03/26 | Not stated by source | CDE |
| 江西迪赛诺医药集团有限公司 | CYHS2600566 | Generic | 2026/02/27 | Not stated by source | CDE |
| 浙江东亚药业股份有限公司 | CYHS2600397 | Generic | 2026/02/06 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2600139 | Generic | 2026/01/10 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2600138 | Generic | 2026/01/10 | Not stated by source | CDE |
| 北京福元医药股份有限公司 | CYHS2600012 | Generic | 2026/01/05 | Not stated by source | CDE |
API registrations
Non-component matches: 7 companies with A status and 12 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 |
|---|---|---|---|---|---|---|
| 巴瑞替尼 | 乳源东阳光药业有限公司 | Y20260000673 | I | Exact ingredient | 2026/09/01 | CDE |
| 巴瑞替尼 | 武邑慈航药业有限公司 | Y20260000638 | I | Exact ingredient | 2026/08/04 | CDE |
| 巴瑞替尼 | 山东济坤生物制药有限公司 | Y20260000592 | I | Exact ingredient | 2026/07/14 | CDE |
| 巴瑞替尼 | 辽宁兴海制药有限公司 | Y20260000400 | I | Exact ingredient | 2026/05/15 | CDE |
| 巴瑞替尼 | 山东道合药业有限公司 | Y20260000212 | I | Exact ingredient | 2026/05/11 | CDE |
| 巴瑞替尼 | 上海中西三维药业有限公司 | Y20250001467 | I | Exact ingredient | 2026/01/15 | CDE |
| 巴瑞替尼 | 湖北美林药业有限公司 | Y20250001378 | I | Exact ingredient | 2025/12/29 | CDE |
| 巴瑞替尼 | 安徽贝克制药股份有限公司 | Y20250001127 | I | Exact ingredient | 2025/12/26 | CDE |
| 巴瑞替尼 | 兰西哈三联制药有限公司 | Y20250001134 | I | Exact ingredient | 2025/11/11 | CDE |
| 巴瑞替尼 | 宜昌天睿生物医药有限责任公司 | Y20250000826 | I | Exact ingredient | 2025/08/19 | CDE |
| 巴瑞替尼 | 山东新时代药业有限公司 | Y20250000801 | I | Exact ingredient | 2025/08/11 | CDE |
| 巴瑞替尼 | 浙江华海建诚药业有限公司 | Y20250000399 | I | Exact ingredient | 2025/04/30 | CDE |
| 巴瑞替尼 | 福建南方制药股份有限公司 | Y20230000885 | A | Exact ingredient | 2026/03/26 | CDE |
| 巴瑞替尼 | 徐州万邦金桥制药有限公司 | Y20240000287 | A | Exact ingredient | 2025/12/25 | CDE |
| 巴瑞替尼 | 南京海纳制药有限公司 | Y20240000293 | A | Exact ingredient | 2026/02/13 | CDE |
| 巴瑞替尼 | 天地恒一制药股份有限公司 | Y20240000146 | A | Exact ingredient | 2026/07/16 | CDE |
| 巴瑞替尼 | 广州绿十字制药股份有限公司 | Y20230000965 | A | Exact ingredient | 2026/05/20 | CDE |
| 巴瑞替尼 | Natco Pharma Limited | Y20230000557 | A | Exact ingredient | 2025/12/17 | CDE |
| 巴瑞替尼 | 南京力博维制药有限公司 | Y20210000460 | A | Exact ingredient | 2024/05/16 | 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.
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2026/10/21Accepted
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2026/10/20Marketing application approved
昆山龙灯瑞迪制药有限公司
CYHS2501647 · 国药准字H20266382
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 61 ↗ -
2026/10/20Marketing application approved
昆山龙灯瑞迪制药有限公司
CYHS2501646 · 国药准字H20266381
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 60 ↗ -
2026/09/23Accepted
湖北民康制药有限公司;南京海纳制药有限公司
CYHS2602396
Fact date: 2026/09/23 · Site observation date: 2026/10/21
View source ↗ -
2026/09/23Accepted
湖北民康制药有限公司;南京海纳制药有限公司
CYHS2602395
Fact date: 2026/09/23 · Site observation date: 2026/10/21
View source ↗ -
2026/09/22Accepted
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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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