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: 15 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 9 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 |
|---|---|---|---|---|---|---|
| 湖南千金湘江药业股份有限公司 | 湖南千金湘江药业股份有限公司 | 国药准字H20265853 | 2026/09/02 | 0.1g | 按化学药品新注册分类批准的仿制药 | CDE |
| 浙江华海药业股份有限公司 | 浙江华海药业股份有限公司 | 国药准字H20265277 | 2026/07/21 | 0.1g | 按化学药品新注册分类批准的仿制药 | CDE |
| 江苏万高药业股份有限公司 | 江苏万高药业股份有限公司 | 国药准字H20265019 | 2026/06/30 | 0.1g | 按化学药品新注册分类批准的仿制药 | CDE |
| 北京斯利安药业有限公司 | 北京斯利安药业有限公司 | 国药准字H20264043 | 2026/04/21 | 0.1g | 按化学药品新注册分类批准的仿制药 | CDE |
| 安徽佳和药业有限公司 | 安徽佳和药业有限公司 | 国药准字H20264045 | 2026/04/21 | 0.1g | 按化学药品新注册分类批准的仿制药 | CDE |
| 瑞阳制药股份有限公司 | 瑞阳制药股份有限公司 | 国药准字H20263716 | 2026/03/25 | 0.1g | 按化学药品新注册分类批准的仿制药 | CDE |
| 合肥英太制药有限公司 | 合肥英太制药有限公司 | 国药准字H20256310 | 2025/12/16 | 0.1g | 按化学药品新注册分类批准的仿制药 | CDE |
| 华益药业科技(安徽)有限公司 | 华益药业科技(安徽)有限公司 | 国药准字H20256304 | 2025/12/16 | 0.1g | 按化学药品新注册分类批准的仿制药 | CDE |
| 江苏中天药业有限公司 | 江苏中天药业有限公司 | 国药准字H20255296 | 2025/09/02 | 0.1g | 其他药品 | 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H20249775 | 2024/12/25 | 0.1g | 其他药品 | CDE |
| 北京福元医药股份有限公司 | 北京福元医药股份有限公司 | 国药准字H20244789 | 2024/09/03 | 0.1克 | 按化学药品新注册分类批准的仿制药 | CDE |
| 成都奥邦药业有限公司 | 成都奥邦药业有限公司 | 国药准字H20083003 | 2023/08/02 | 0.1g | 通过质量和疗效一致性评价的药品 | CDE |
| 湖南华纳大药厂股份有限公司 | 湖南华纳大药厂股份有限公司 | 国药准字H20133230 | 2022/11/18 | 0.1g | 通过质量和疗效一致性评价的药品 | CDE |
| 湖南九典制药股份有限公司 | 湖南九典制药股份有限公司 | 国药准字H20193239 | 2022/06/09 | 0.1g | 通过质量和疗效一致性评价的药品 | CDE |
| 金陵药业股份有限公司南京金陵制药厂 | 金陵药业股份有限公司南京金陵制药厂 | 国药准字H10930005 | 2022/01/28 | 0.1g | 通过质量和疗效一致性评价的药品 | 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: 16 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京斯利安药业有限公司 | 国药准字H20264043 | 0.1g | 甲 | XB03AAH026A001010100011 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20244789 | 0.1克 | 甲 | XB03AAH026A001010100177 | NHSA |
| 广州绿十字制药股份有限公司 | 国药准字H20249775 | 0.1g | 甲 | XB03AAH026A001010100475 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20265019 | 0.1g | 甲 | XB03AAH026A001010101503 | NHSA |
| 金陵药业股份有限公司南京金陵制药厂 | 国药准字H10930005 | 0.1g | 甲 | XB03AAH026A001010101529 | NHSA |
| 成都奥邦药业有限公司 | 国药准字H20083003 | 0.1g | 甲 | XB03AAH026A001010102118 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20263716 | 0.1g | 甲 | XB03AAH026A001010104152 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20265277 | 0.1g | 甲 | XB03AAH026A001010104647 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20133230 | 0.1g | 甲 | XB03AAH026A001010104929 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20193239 | 0.1g | 甲 | XB03AAH026A001010104942 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20265853 | 0.1g | 甲 | XB03AAH026A001010104960 | NHSA |
| 合肥英太制药有限公司 | 国药准字H20256310 | 0.1g | 甲 | XB03AAH026A001010180698 | NHSA |
| 江苏中天药业有限公司 | 国药准字H20255296 | 0.1g | 甲 | XB03AAH026A001010181457 | NHSA |
| 广州市亿源医药有限公司 | 国药准字H20264714 | 0.1克 | 甲 | XB03AAH026A001010184691 | NHSA |
| 安徽佳和药业有限公司 | 国药准字H20264045 | 0.1g | 甲 | XB03AAH026A001010185179 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20244789 | 0.1克 | 甲 | XB03AAH026A001010200177 | NHSA |
| 广州绿十字制药股份有限公司 | 国药准字H20249775 | 0.1g | 甲 | XB03AAH026A001010200475 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20265019 | 0.1g | 甲 | XB03AAH026A001010201503 | NHSA |
| 金陵药业股份有限公司南京金陵制药厂 | 国药准字H10930005 | 0.1g | 甲 | XB03AAH026A001010201529 | NHSA |
| 成都奥邦药业有限公司 | 国药准字H20083003 | 0.1g | 甲 | XB03AAH026A001010202118 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20265277 | 0.1g | 甲 | XB03AAH026A001010204647 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20133230 | 0.1g | 甲 | XB03AAH026A001010204929 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20193239 | 0.1g | 甲 | XB03AAH026A001010204942 | NHSA |
| 合肥英太制药有限公司 | 国药准字H20256310 | 0.1g | 甲 | XB03AAH026A001010280698 | NHSA |
| 江苏中天药业有限公司 | 国药准字H20255296 | 0.1g | 甲 | XB03AAH026A001010281457 | NHSA |
| 华益药业科技(安徽)有限公司 | 国药准字H20256304 | 0.1g | 甲 | XB03AAH026A001010284212 | NHSA |
| 广州市亿源医药有限公司 | 国药准字H20264714 | 0.1克 | 甲 | XB03AAH026A001010284691 | NHSA |
| 安徽佳和药业有限公司 | 国药准字H20264045 | 0.1g | 甲 | XB03AAH026A001010285179 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20244789 | 0.1克 | 甲 | XB03AAH026A001010300177 | NHSA |
| 广州绿十字制药股份有限公司 | 国药准字H20249775 | 0.1g | 甲 | XB03AAH026A001010300475 | NHSA |
| 金陵药业股份有限公司南京金陵制药厂 | 国药准字H10930005 | 0.1g | 甲 | XB03AAH026A001010301529 | NHSA |
| 成都奥邦药业有限公司 | 国药准字H20083003 | 0.1g | 甲 | XB03AAH026A001010302118 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20265277 | 0.1g | 甲 | XB03AAH026A001010304647 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20133230 | 0.1g | 甲 | XB03AAH026A001010304929 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20193239 | 0.1g | 甲 | XB03AAH026A001010304942 | NHSA |
| 合肥英太制药有限公司 | 国药准字H20256310 | 0.1g | 甲 | XB03AAH026A001010380698 | NHSA |
| 江苏中天药业有限公司 | 国药准字H20255296 | 0.1g | 甲 | XB03AAH026A001010381457 | NHSA |
| 华益药业科技(安徽)有限公司 | 国药准字H20256304 | 0.1g | 甲 | XB03AAH026A001010384212 | NHSA |
| 广州市亿源医药有限公司 | 国药准字H20264714 | 0.1克 | 甲 | XB03AAH026A001010384691 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20244789 | 0.1克 | 甲 | XB03AAH026A001010400177 | NHSA |
| 广州绿十字制药股份有限公司 | 国药准字H20249775 | 0.1g | 甲 | XB03AAH026A001010400475 | NHSA |
| 金陵药业股份有限公司南京金陵制药厂 | 国药准字H10930005 | 0.1g | 甲 | XB03AAH026A001010401529 | NHSA |
| 成都奥邦药业有限公司 | 国药准字H20083003 | 0.1g | 甲 | XB03AAH026A001010402118 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20265277 | 0.1g | 甲 | XB03AAH026A001010404647 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20193239 | 0.1g | 甲 | XB03AAH026A001010404942 | NHSA |
| 江苏中天药业有限公司 | 国药准字H20255296 | 0.1g | 甲 | XB03AAH026A001010481457 | NHSA |
| 广州市亿源医药有限公司 | 国药准字H20264714 | 0.1克 | 甲 | XB03AAH026A001010484691 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20244789 | 0.1克 | 甲 | XB03AAH026A001010500177 | NHSA |
| 金陵药业股份有限公司南京金陵制药厂 | 国药准字H10930005 | 0.1g | 甲 | XB03AAH026A001010501529 | NHSA |
| 成都奥邦药业有限公司 | 国药准字H20083003 | 0.1g | 甲 | XB03AAH026A001010502118 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20193239 | 0.1g | 甲 | XB03AAH026A001010504942 | NHSA |
| 江苏中天药业有限公司 | 国药准字H20255296 | 0.1g | 甲 | XB03AAH026A001010581457 | NHSA |
| 广州市亿源医药有限公司 | 国药准字H20264714 | 0.1克 | 甲 | XB03AAH026A001010584691 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20244789 | 0.1克 | 甲 | XB03AAH026A001010600177 | NHSA |
| 成都奥邦药业有限公司 | 国药准字H20083003 | 0.1g | 甲 | XB03AAH026A001010602118 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20193239 | 0.1g | 甲 | XB03AAH026A001010604942 | NHSA |
| 江苏中天药业有限公司 | 国药准字H20255296 | 0.1g | 甲 | XB03AAH026A001010681457 | NHSA |
| 广州市亿源医药有限公司 | 国药准字H20264714 | 0.1克 | 甲 | XB03AAH026A001010684691 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20244789 | 0.1克 | 甲 | XB03AAH026A001010700177 | NHSA |
| 成都奥邦药业有限公司 | 国药准字H20083003 | 0.1g | 甲 | XB03AAH026A001010702118 | NHSA |
| 广州市亿源医药有限公司 | 国药准字H20264714 | 0.1克 | 甲 | XB03AAH026A001010784691 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20244789 | 0.1克 | 甲 | XB03AAH026A001010800177 | NHSA |
| 广州市亿源医药有限公司 | 国药准字H20264714 | 0.1克 | 甲 | XB03AAH026A001010884691 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20193239 | 0.1g | 甲 | XB03AAH026A001020104942 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20193239 | 0.1g | 甲 | XB03AAH026A001020704942 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20193239 | 0.1g | 甲 | XB03AAH026A001020804942 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20193239 | 0.1g | 甲 | XB03AAH026A001030104942 | 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: 21 filings and 21 distinct first applicants.
Generic 20 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏润恒制药有限公司 | CYHS2504452 | Generic | 2025/12/29 | Not stated by source | CDE |
| 德全药品(江苏)股份有限公司 | CYHS2602118 | Generic | 2026/08/25 | Not stated by source | CDE |
| 金陵药业股份有限公司南京金陵制药厂 | CYHB2601431 | Supplement | 2026/07/24 | Not stated by source | CDE |
| 浙江前进药业有限公司 | CYHS2601997 | Generic | 2026/08/13 | Not stated by source | CDE |
| 安徽正药医药科技有限公司;华益药业科技(安徽)有限公司 | CYHS2601935 | Generic | 2026/08/07 | Not stated by source | CDE |
| 重庆希尔安药业有限公司;重庆国泰康宁制药有限责任公司 | CYHS2601757 | Generic | 2026/07/22 | Not stated by source | CDE |
| 临汾宝珠制药有限公司 | CYHS2601649 | Generic | 2026/07/09 | Not stated by source | CDE |
| 浙江核力欣健药业有限公司 | CYHS2601433 | Generic | 2026/06/17 | Not stated by source | CDE |
| 昆明源瑞制药有限公司 | CYHS2600954 | Generic | 2026/04/24 | Not stated by source | CDE |
| 广东恒健制药有限公司 | CYHS2600868 | Generic | 2026/04/15 | Not stated by source | CDE |
| 北京仁众药业有限公司 | CYHS2600404 | Generic | 2026/02/07 | Not stated by source | CDE |
| 浙江远力健药业有限责任公司 | CYHS2600370 | Generic | 2026/02/05 | Not stated by source | CDE |
| 天津柏海药业有限责任公司 | CYHS2600087 | Generic | 2026/01/08 | Not stated by source | CDE |
| 山西宝泰药业有限责任公司 | CYHS2504518 | Generic | 2025/12/31 | Not stated by source | CDE |
| 郑州泰丰制药有限公司 | CYHS2502145 | Generic | 2025/06/17 | Not stated by source | CDE |
| 陕西巨成生物医药生产力促进中心有限公司;华益药业科技(安徽)有限公司 | CYHS2501589 | Generic | 2025/04/28 | Not stated by source | CDE |
| 浙江赛默制药有限公司 | CYHS2501379 | Generic | 2025/04/10 | Not stated by source | CDE |
| 山西同达药业有限公司 | CYHS2501200 | Generic | 2025/03/27 | Not stated by source | CDE |
| 上海金不换兰考制药有限公司 | CYHS2501199 | Generic | 2025/03/27 | Not stated by source | CDE |
| 江西泰吉立生物医药科技有限公司;浙江赛默制药有限公司 | CYHS2500733 | Generic | 2025/02/13 | Not stated by source | CDE |
| 成都克莱蒙医药科技有限公司;成都天台山制药股份有限公司 | CYHS2602669 | Generic | 2026/11/02 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 12 filings and 12 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 德全药品(江苏)股份有限公司 | CYHS2602118 | Generic | 2026/08/25 | Not stated by source | CDE |
| 浙江前进药业有限公司 | CYHS2601997 | Generic | 2026/08/13 | Not stated by source | CDE |
| 安徽正药医药科技有限公司;华益药业科技(安徽)有限公司 | CYHS2601935 | Generic | 2026/08/07 | Not stated by source | CDE |
| 重庆希尔安药业有限公司;重庆国泰康宁制药有限责任公司 | CYHS2601757 | Generic | 2026/07/22 | Not stated by source | CDE |
| 临汾宝珠制药有限公司 | CYHS2601649 | Generic | 2026/07/09 | Not stated by source | CDE |
| 浙江核力欣健药业有限公司 | CYHS2601433 | Generic | 2026/06/17 | Not stated by source | CDE |
| 昆明源瑞制药有限公司 | CYHS2600954 | Generic | 2026/04/24 | Not stated by source | CDE |
| 广东恒健制药有限公司 | CYHS2600868 | Generic | 2026/04/15 | Not stated by source | CDE |
| 北京仁众药业有限公司 | CYHS2600404 | Generic | 2026/02/07 | Not stated by source | CDE |
| 浙江远力健药业有限责任公司 | CYHS2600370 | Generic | 2026/02/05 | Not stated by source | CDE |
| 天津柏海药业有限责任公司 | CYHS2600087 | Generic | 2026/01/08 | Not stated by source | CDE |
| 成都克莱蒙医药科技有限公司;成都天台山制药股份有限公司 | CYHS2602669 | Generic | 2026/11/02 | Not stated by source | CDE |
API registrations
Non-component matches: 8 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 琥珀酸亚铁 | 湖北亨迪药业股份有限公司 | Y20260000780 | I | Exact ingredient | 2026/09/10 | CDE |
| 琥珀酸亚铁 | 河南优凯制药有限公司 | Y20260000213 | I | Exact ingredient | 2026/03/30 | CDE |
| 琥珀酸亚铁 | 瑞阳制药股份有限公司 | Y20250000535 | I | Exact ingredient | 2025/06/04 | CDE |
| 琥珀酸亚铁 | 池州东升药业有限公司 | Y20230001367 | A | Exact ingredient | 2025/05/20 | CDE |
| 琥珀酸亚铁 | 连云港贵科药业有限公司 | Y20230000866 | A | Exact ingredient | 2025/09/11 | CDE |
| 琥珀酸亚铁 | 宣城美诺华药业有限公司 | Y20220000178 | A | Exact ingredient | 2024/01/31 | CDE |
| 琥珀酸亚铁 | 金鸿药业股份有限公司 | Y20210000267 | A | Exact ingredient | 2023/08/24 | CDE |
| 琥珀酸亚铁 | 湖南华纳大药厂手性药物有限公司 | Y20190008919 | A | Exact ingredient | 2023/04/19 | CDE |
| 琥珀酸亚铁 | 成都奥邦药业有限公司 | Y20190005747 | A | Exact ingredient | 2025/09/16 | CDE |
| 琥珀酸亚铁 | 金陵药业股份有限公司南京金陵制药厂 | Y20190003584 | A | Exact ingredient | 2024/12/28 | CDE |
| 琥珀酸亚铁 | 湖南九典宏阳制药有限公司 | Y20170001256 | A | Exact ingredient | 2025/04/03 | 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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2026/11/02Accepted
成都克莱蒙医药科技有限公司;成都天台山制药股份有限公司
CYHS2602669
Fact date: 2026/11/02 · Site observation date: 2026/11/03
View source ↗ -
2026/10/26Marketing application approved
赤峰固得药业有限公司
CYHS2404279 · 国药准字H20266409
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 21 ↗ -
2026/09/09Accepted
安士制药(中山)有限公司;华益药业科技(安徽)有限公司
CYHB2601708
Fact date: 2026/09/09 · Site observation date: 2026/10/22
View source ↗ -
2026/08/25Accepted
-
2026/08/13Accepted
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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