Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 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: 15 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 11 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 |
|---|---|---|---|---|---|---|
| 常州四药制药有限公司 | 常州四药制药有限公司 | 国药准字H20264805 | 2026/06/17 | 1ml:100μg | 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 |
| 云南药科院生物医药股份有限公司 | 楚雄和创药业有限责任公司 | 国药准字H20256210 | 2025/12/09 | 1ml:100μg | 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 |
| 浙江杭康药业有限公司 | 浙江杭康药业有限公司 | 国药准字H20255804 | 2025/10/28 | 1ml:100μg | 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 |
| 湖北长联杜勒制药有限公司 | 湖北长联杜勒制药有限公司 | 国药准字H20255583 | 2025/09/30 | 1ml: 100μg | 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 |
| 成都诺和晟鸿生物制药有限公司 | 四川美大康佳乐药业有限公司 | 国药准字H20249486 | 2024/12/01 | 1ml:100μg | 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 |
| 成都通德药业有限公司 | 成都通德药业有限公司 | 国药准字H20249083 | 2024/10/16 | 1ml:100μg | 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 |
| 海南中和药业股份有限公司 | 海南中和药业股份有限公司 | 国药准字H20243798 | 2024/05/21 | 1ml:100μg | 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 |
| 成都圣诺生物制药有限公司 | 成都圣诺生物制药有限公司 | 国药准字H20163001 | 2023/08/31 | 1ml:100μg(按C45H69N11O12S计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 南京星银药业集团有限公司 | 南京星银药业集团有限公司 | 国药准字H20193159 | 2023/07/31 | 1ml:100μg(按C45H69N11O12S计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 苏州天马医药集团天吉生物制药有限公司 | 苏州天马医药集团天吉生物制药有限公司 | 国药准字H20193373 | 2023/07/17 | 1ml∶100μg(按C45H69N11O12S计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 海南皇隆制药股份有限公司 | 成都利尔药业有限公司 | 国药准字H20233887 | 2023/06/30 | 1ml:100μg | 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 |
| 辰欣药业股份有限公司 | 辰欣药业股份有限公司 | 国药准字H20233591 | 2023/05/19 | 1ml:100μg | 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 |
| 南京康舟医药科技有限公司 | 苏州二叶制药有限公司 | 国药准字H20233447 | 2023/04/11 | 1ml:100μg | 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 |
| 深圳翰宇药业股份有限公司 | 深圳翰宇药业股份有限公司 | 国药准字H20163024 | 2021/02/26 | 1ml:100μg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 杭州澳亚生物技术有限公司 | 杭州澳亚生物技术有限公司 | 国药准字H20203627 | 2020/12/02 | 1ml:100μg | 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 |
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: 16 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 常州四药制药有限公司 | 国药准字H20264805 | 1ml:100μg | Category B (乙) | XH01BBK007B002010101389 | NHSA |
| 南京星银药业集团有限公司 | 国药准字H20193159 | 1ml:100µg(按C45H69N11O12S计) | Category B (乙) | XH01BBK007B002010101601 | NHSA |
| 苏州天马医药集团天吉生物制药有限公司 | 国药准字H20193373 | 1ml∶100μg | Category B (乙) | XH01BBK007B002010101669 | NHSA |
| 海南皇隆制药股份有限公司 | 国药准字H20233887 | 1ml:100μg | Category B (乙) | XH01BBK007B002010102044 | NHSA |
| 成都通德药业有限公司 | 国药准字H20249083 | 1ml:100µg | Category B (乙) | XH01BBK007B002010102068 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20233591 | 1ml:100μg | Category B (乙) | XH01BBK007B002010104127 | NHSA |
| 广东金城金素制药有限公司 | 国药准字H20203627 | 1ml:100μg | Category B (乙) | XH01BBK007B002010104470 | NHSA |
| 浙江杭康药业有限公司 | 国药准字H20255804 | 1ml:100μg | Category B (乙) | XH01BBK007B002010104642 | NHSA |
| 海南中和药业股份有限公司 | 国药准字H20243798 | 1ml:100μg | Category B (乙) | XH01BBK007B002010105842 | NHSA |
| 辉凌制药(中国)有限公司 | 国药准字H20093500 | 1ml:100μg | Category B (乙) | XH01BBK007B002010107572 | NHSA |
| 成都圣诺生物制药有限公司 | 国药准字H20163001 | 1ml:100µg(按C₄₅H₆₉N₁₁O₁₂S计) | Category B (乙) | XH01BBK007B002010107821 | NHSA |
| 深圳翰宇药业股份有限公司 | 国药准字H20163024 | 1ml:100μg | Category B (乙) | XH01BBK007B002010179260 | NHSA |
| 湖北长联杜勒制药有限公司 | 国药准字H20255583 | 1ml:100μg | Category B (乙) | XH01BBK007B002010181000 | NHSA |
| 南京康舟医药科技有限公司 | 国药准字H20233447 | 1ml:100μg | Category B (乙) | XH01BBK007B002010183233 | NHSA |
| 云南药科院生物医药股份有限公司 | 国药准字H20256210 | 1ml:100μg | Category B (乙) | XH01BBK007B002010184547 | NHSA |
| 海南通用三洋药业有限公司 | 国药准字H20249486 | 1ml:100μg | Category B (乙) | XH01BBK007B002010184983 | NHSA |
| 海南皇隆制药股份有限公司 | 国药准字H20233887 | 1ml:100μg | Category B (乙) | XH01BBK007B002010202044 | NHSA |
| 成都通德药业有限公司 | 国药准字H20249083 | 1ml:100µg | Category B (乙) | XH01BBK007B002010202068 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20233591 | 1ml:100μg | Category B (乙) | XH01BBK007B002010204127 | NHSA |
| 广东金城金素制药有限公司 | 国药准字H20203627 | 1ml:100μg | Category B (乙) | XH01BBK007B002010204470 | NHSA |
| 浙江杭康药业有限公司 | 国药准字H20255804 | 1ml:100μg | Category B (乙) | XH01BBK007B002010204642 | NHSA |
| 辉凌制药(中国)有限公司 | 国药准字H20093500 | 1ml:100μg | Category B (乙) | XH01BBK007B002010207572 | NHSA |
| 深圳翰宇药业股份有限公司 | 国药准字H20163024 | 1ml:100μg | Category B (乙) | XH01BBK007B002010279260 | NHSA |
| 南京康舟医药科技有限公司 | 国药准字H20233447 | 1ml:100μg | Category B (乙) | XH01BBK007B002010283233 | NHSA |
| 云南药科院生物医药股份有限公司 | 国药准字H20256210 | 1ml:100μg | Category B (乙) | XH01BBK007B002010284547 | NHSA |
| 海南通用三洋药业有限公司 | 国药准字H20249486 | 1ml:100μg | Category B (乙) | XH01BBK007B002010284983 | NHSA |
| 海南皇隆制药股份有限公司 | 国药准字H20233887 | 1ml:100μg | Category B (乙) | XH01BBK007B002010302044 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20233591 | 1ml:100μg | Category B (乙) | XH01BBK007B002010304127 | NHSA |
| 深圳翰宇药业股份有限公司 | 国药准字H20163024 | 1ml:100μg | Category B (乙) | XH01BBK007B002010379260 | NHSA |
| 南京康舟医药科技有限公司 | 国药准字H20233447 | 1ml:100μg | Category B (乙) | XH01BBK007B002010383233 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20233591 | 1ml:100μg | Category B (乙) | XH01BBK007B002010404127 | NHSA |
| 南京星银药业集团有限公司 | 国药准字H20193159 | 1ml:100µg(按C45H69N11O12S计) | Category B (乙) | XH01BBK007B002020101601 | NHSA |
| 成都圣诺生物制药有限公司 | 国药准字H20163001 | 1ml:100µg(按C₄₅H₆₉N₁₁O₁₂S计) | Category B (乙) | XH01BBK007B002020107821 | 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 6 distinct first applicants.
Generic 5 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海纳制药有限公司 | CYHS2601516 | Generic | 2026/06/26 | Not stated by source | CDE |
| 江西泰吉立生物制药有限公司 | CYHS2602469 | Generic | 2026/10/09 | Not stated by source | CDE |
| 天津天士力之骄药业有限公司 | CYHS2601175 | Generic | 2026/05/19 | Not stated by source | CDE |
| 辉凌制药(中国)有限公司 | CYHB2600349 | Supplement | 2026/02/13 | Not stated by source | CDE |
| 武汉九珑医药有限责任公司;武汉人福药业有限责任公司 | CYHS2503615 | Generic | 2025/10/10 | Not stated by source | CDE |
| 成都天台山制药股份有限公司 | CYHS2502701 | Generic | 2025/07/25 | Not stated by source | CDE |
Loaded records: 3 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海纳制药有限公司 | CYHS2601516 | Generic | 2026/06/26 | Not stated by source | CDE |
| 江西泰吉立生物制药有限公司 | CYHS2602469 | Generic | 2026/10/09 | Not stated by source | CDE |
| 天津天士力之骄药业有限公司 | CYHS2601175 | Generic | 2026/05/19 | Not stated by source | CDE |
Non-component matches: 12 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 卡贝缩宫素 | 上海苏豪逸明制药有限公司 | Y20250000702 | I | Exact ingredient | 2025/08/08 | CDE |
| 卡贝缩宫素 | 湖北长联杜勒制药有限公司 | Y20230000581 | A | Exact ingredient | 2026/04/02 | CDE |
| 卡贝缩宫素 | 海南中和药业股份有限公司 | Y20220000880 | A | Exact ingredient | 2026/08/07 | CDE |
| 卡贝缩宫素 | 山东辰龙药业有限公司 | Y20210000924 | A | Exact ingredient | 2025/04/29 | CDE |
| 卡贝缩宫素 | 成都天台山制药股份有限公司 | Y20210000802 | A | Exact ingredient | 2026/06/25 | CDE |
| 卡贝缩宫素 | 翰宇药业(武汉)有限公司 | Y20210000447 | A | Exact ingredient | 2024/01/17 | CDE |
| 卡贝缩宫素 | 哈尔滨吉象隆生物技术有限公司 | Y20200001248 | A | Exact ingredient | 2023/08/21 | CDE |
| 卡贝缩宫素 | PolyPeptide Laboratories France | Y20190009322 | A | Exact ingredient | 2025/12/31 | CDE |
| 卡贝缩宫素 | PolyPeptide Laboratories France | Y20190009319 | A | Exact ingredient | 2025/12/31 | CDE |
| 卡贝缩宫素 | PolyPeptide Laboratories France | Y20190009318 | A | Exact ingredient | 2025/12/31 | CDE |
| 卡贝缩宫素 | PolyPeptide Laboratories France | Y20190009317 | A | Exact ingredient | 2025/12/31 | CDE |
| 卡贝缩宫素 | 深圳翰宇药业股份有限公司 | Y20190006054 | A | Exact ingredient | 2023/03/24 | CDE |
| 卡贝缩宫素 | 成都圣诺生物制药有限公司 | Y20190005921 | A | Exact ingredient | 2025/09/16 | CDE |
| 卡贝缩宫素 | 浙江尚泰生物制药有限公司 | Y20180000967 | A | Exact ingredient | 2026/09/23 | CDE |
| 卡贝缩宫素 | 苏州天马医药集团天吉生物制药有限公司 | Y20170000889 | A | Exact ingredient | 2024/01/25 | CDE |
| 卡贝缩宫素 | 南京星银药业集团有限公司 | Y20170000323 | A | Exact ingredient | 2024/04/18 | 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.
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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