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Companies, stages and changes, with each record available on this page.
Last 90 days: No longer listed under review: 1 application
Current coverage may be incomplete
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Loaded records: 14 holders; 4 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 |
|---|---|---|---|---|---|---|
| 安徽省先锋制药有限公司 | 安徽省先锋制药有限公司 | 国药准字H20265067 | 2026/07/08 | 0.2g(20万单位) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 泊诺(天津)创新医药研究有限公司 | 天津生物化学制药有限公司 | 国药准字H20254646 | 2025/06/24 | 0.2g(20万单位) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江普利药业有限公司 | 浙江普利药业有限公司 | 国药准字H20254617 | 2025/06/24 | 0.2g(20 万单位) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 福安药业集团烟台只楚药业有限公司 | 福安药业集团烟台只楚药业有限公司 | 国药准字H20253762 | 2025/04/01 | 0.2g(20万单位) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 东阳祥昇医药科技有限公司 | 丹东医创药业有限责任公司 | 国药准字H20253606 | 2025/03/11 | 0.2g(20万单位) | Not stated by source | CDE |
| 北京吉洛华制药有限公司 | 重庆药友制药有限责任公司 | 国药准字H20253100 | 2025/01/08 | 0.2g (20万单位) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 杭州沐源生物医药科技有限公司 | 海南灵康制药有限公司 | 国药准字H20249316 | 2024/11/15 | 0.2g(20万单位) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 海南倍特药业有限公司 | 海南倍特药业有限公司 | 国药准字H20249218 | 2024/10/29 | 0.2g(20万单位) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 四川汇宇制药股份有限公司 | 四川汇宇制药股份有限公司 | 国药准字H20249206 | 2024/10/29 | 0.4g(40万单位) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 四川汇宇制药股份有限公司 | 四川汇宇制药股份有限公司 | 国药准字H20249205 | 2024/10/29 | 0.2g(20万单位) | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江医药股份有限公司新昌制药厂 | 浙江医药股份有限公司新昌制药厂 | 国药准字H20247194 | 2024/08/22 | 0.4g(40万单位) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 华北制药股份有限公司 | 华北制药股份有限公司 | 国药准字H20123375 | 2024/08/19 | 0.2g(20万单位) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 浙江海正药业股份有限公司 | 浙江海正药业股份有限公司 | 国药准字H20093651 | 2024/07/08 | 0.2g(20万单位) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 浙江医药股份有限公司 | 浙江医药股份有限公司新昌制药厂 | 国药准字H20040387 | 2021/02/26 | 0.2g(20万单位) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| Sanofi S.p.A | Sanofi S.p.A | H20160587;H20160586 | 2000/12/15 | 200mg | Imported originator drug (进口原研药品) | 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.
Loaded records: 17 distinct approval numbers and 13 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京吉洛华制药有限公司 | 国药准字H20253100 | 0.2g (20万单位) | Category B (乙) | XJ01XAT037B001010101066 | NHSA |
| 四川汇宇制药股份有限公司 | 国药准字H20249205 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010102317 | NHSA |
| 华北制药股份有限公司 | 国药准字H20123375 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010102697 | NHSA |
| 福安药业集团烟台只楚药业有限公司 | 国药准字H20253762 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010104251 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20265067 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010104339 | NHSA |
| 浙江海正药业股份有限公司 | 国药准字H20093651 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010104641 | NHSA |
| 浙江医药股份有限公司新昌制药厂 | 国药准字H20040387 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010104747 | NHSA |
| 海南倍特药业有限公司 | 国药准字H20249218 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010105791 | NHSA |
| 浙江医药股份有限公司新昌制药厂 | 国药准字H20247194 | 0.4g(40万单位) | Category B (乙) | XJ01XAT037B001010107968 | NHSA |
| Sanofi S.r.l. | 国药准字J20171006 | 200mg | Category B (乙) | XJ01XAT037B001010182032 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20254617 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010182922 | NHSA |
| 杭州沐源生物医药科技股份有限公司 | 国药准字H20249316 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010184135 | NHSA |
| 东阳祥昇医药科技有限公司 | 国药准字H20253606 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010184294 | NHSA |
| 泊诺(天津)创新医药研究有限公司 | 国药准字H20254646 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010184606 | NHSA |
| 四川汇宇制药股份有限公司 | 国药准字H20249205 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010202317 | NHSA |
| 福安药业集团烟台只楚药业有限公司 | 国药准字H20253762 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010204251 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20265067 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010204339 | NHSA |
| 海南倍特药业有限公司 | 国药准字H20249218 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010205791 | NHSA |
| Sanofi S.r.l. | 国药准字HJ20160586 | 200mg | Category B (乙) | XJ01XAT037B001010281683 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20254617 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010282922 | NHSA |
| 东阳祥昇医药科技有限公司 | 国药准字H20253606 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010284294 | NHSA |
| 泊诺(天津)创新医药研究有限公司 | 国药准字H20254646 | 0.2g(20万单位) | Category B (乙) | XJ01XAT037B001010284606 | NHSA |
| 四川汇宇制药股份有限公司 | 国药准字H20249206 | 0.4g(40万单位) | Category B (乙) | XJ01XAT037B001020102317 | NHSA |
| 华北制药股份有限公司 | 国药准字H20123376 | 0.4g(40万单位) | Category B (乙) | XJ01XAT037B001020102697 | NHSA |
| 四川汇宇制药股份有限公司 | 国药准字H20249206 | 0.4g(40万单位) | Category B (乙) | XJ01XAT037B001020202317 | 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.
Loaded records: 6 filings and 5 distinct first applicants.
Generic 3 · Supplement 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山西威奇达光明制药有限公司 | CYHS2600922 | Generic | 2026/04/22 | Not stated by source | CDE |
| 石家庄四药有限公司 | CYHS2600877 | Generic | 2026/04/16 | Not stated by source | CDE |
| 合肥启旸生物医药科技有限公司;马鞍山丰原制药有限公司 | CYHS2504182 | Generic | 2025/12/05 | Not stated by source | CDE |
| Sanofi S.r.l. | JYHB2500557 | Supplement | 2025/10/23 | Not stated by source | CDE |
| Sanofi S.r.l. | JYHB2500556 | Supplement | 2025/10/23 | Not stated by source | CDE |
| 浙江海正药业股份有限公司 | CYHB2501986 | Supplement | 2025/10/11 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
Non-component matches: 6 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| 替考拉宁 | 丽珠集团福州福兴医药有限公司 | Y20250000334 | A | Exact ingredient | 2026/01/16 | CDE |
| 替考拉宁 | 浙江昌海制药有限公司 | Y20220000798 | A | Exact ingredient | 2025/03/19 | CDE |
| 替考拉宁 | 丽珠集团福州福兴医药有限公司 | Y20220000563 | A | Exact ingredient | 2026/06/27 | CDE |
| 替考拉宁 | CKD Bio Corporation | Y20220000374 | A | Exact ingredient | 2024/10/15 | CDE |
| 替考拉宁 | 浙江医药股份有限公司新昌制药厂 | Y20190009488 | A | Exact ingredient | 2025/02/06 | CDE |
| 替考拉宁 | 浙江海正药业股份有限公司 | Y20190007431 | A | Exact ingredient | 2024/06/17 | CDE |
| 替考拉宁 | 华北制药华胜有限公司 | Y20190006920 | A | Exact ingredient | — | CDE |
| 替考拉宁 | 浙江医药股份有限公司新昌制药厂 | Y20180001409 | A | Exact ingredient | 2025/07/23 | 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.
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
CYHS2404288
Fact date: 2026/10/24 · Site observation date: 2026/10/24
Accepted: 2024/12/11
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗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.
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.
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 3/30; discovered pending details: 20. Record counts in unscanned portions remain unknown.
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, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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