Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/10 07:27
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: 6 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 1 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 |
|---|---|---|---|---|---|---|
| 福建东瑞制药有限公司 | 福建东瑞制药有限公司 | 国药准字H20041143 | 2024/02/02 | 60mg(以C15H17NaO3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 |
| 重庆科瑞制药(集团)有限公司 | 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 2022/05/26 | 60mg(以C15H17NaO3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 |
| 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H20203538 | 2020/10/27 | 60mg(按C15H17NaO3计) | 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 |
| 卫材(辽宁)制药有限公司 | 卫材(辽宁)制药有限公司 | 国药准字H20041923 | 2020/08/10 | 60mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| — | 迪沙药业集团有限公司 | 国药准字H20050437 | 2020/01/15 | 60mg(以C15H17NaO3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 |
| — | 第一三共制药(上海)有限公司 | 国药准字H20030769 | 2003/08/05 | 60mg | Other drug (其他药品) | 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: 10 distinct approval numbers and 10 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 第一三共制药(上海)有限公司 | 国药准字H20030769 | 60mg | Category B (乙) | XM01AEL283A001010100745 | NHSA |
| 上海旭东海普药业有限公司 | 国药准字H20030614 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010100808 | NHSA |
| 天津新丰制药有限公司 | 国药准字H20030617 | 60mg | Category B (乙) | XM01AEL283A001010100949 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010101016 | NHSA |
| 卫材(辽宁)制药有限公司 | 国药准字H20041923 | 60mg | Category B (乙) | XM01AEL283A001010101337 | NHSA |
| 吉林英联生物制药股份有限公司 | 国药准字H20050114 | 60mg | Category B (乙) | XM01AEL283A001010103336 | NHSA |
| 迪沙药业集团有限公司 | 国药准字H20050437 | 60mg(按C15H17NaO3计) | Category B (乙) | XM01AEL283A001010103944 | NHSA |
| 宁波立华制药有限公司 | 国药准字H20123120 | 60mg(按无水物计)。 | Category B (乙) | XM01AEL283A001010104557 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001010104942 | NHSA |
| 上海旭东海普药业有限公司 | 国药准字H20030614 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010200808 | NHSA |
| 天津新丰制药有限公司 | 国药准字H20030617 | 60mg | Category B (乙) | XM01AEL283A001010200949 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010201016 | NHSA |
| 卫材(辽宁)制药有限公司 | 国药准字H20041923 | 60mg | Category B (乙) | XM01AEL283A001010201337 | NHSA |
| 吉林英联生物制药股份有限公司 | 国药准字H20050114 | 60mg | Category B (乙) | XM01AEL283A001010203336 | NHSA |
| 迪沙药业集团有限公司 | 国药准字H20050437 | 60mg(按C15H17NaO3计) | Category B (乙) | XM01AEL283A001010203944 | NHSA |
| 宁波立华制药有限公司 | 国药准字H20123120 | 60mg(按无水物计)。 | Category B (乙) | XM01AEL283A001010204557 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001010204942 | NHSA |
| 天津新丰制药有限公司 | 国药准字H20030617 | 60mg | Category B (乙) | XM01AEL283A001010300949 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010301016 | NHSA |
| 卫材(辽宁)制药有限公司 | 国药准字H20041923 | 60mg | Category B (乙) | XM01AEL283A001010301337 | NHSA |
| 迪沙药业集团有限公司 | 国药准字H20050437 | 60mg(按C15H17NaO3计) | Category B (乙) | XM01AEL283A001010303944 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001010304942 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010401016 | NHSA |
| 迪沙药业集团有限公司 | 国药准字H20050437 | 60mg(按C15H17NaO3计) | Category B (乙) | XM01AEL283A001010403944 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001010404942 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010501016 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001010504942 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010601016 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001010604942 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010701016 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001010704942 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010801016 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001010804942 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001010901016 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001010904942 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001011001016 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001011004942 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001011101016 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001011104942 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001011201016 | NHSA |
| 湖南九典制药股份有限公司 | 国药准字H20203538 | 60mg(按C₁₅H₁₇NaO₃计) | Category B (乙) | XM01AEL283A001011204942 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001011301016 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001011401016 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001011501016 | NHSA |
| 上海旭东海普药业有限公司 | 国药准字H20030614 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001020100808 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001020101016 | NHSA |
| 卫材(辽宁)制药有限公司 | 国药准字H20041923 | 60mg | Category B (乙) | XM01AEL283A001020101337 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001020201016 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20052275 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001020301016 | NHSA |
| 上海旭东海普药业有限公司 | 国药准字H20030614 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A001030100808 | NHSA |
| 福建东瑞制药有限公司 | 国药准字H20041143 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A017010104876 | NHSA |
| 福建东瑞制药有限公司 | 国药准字H20041143 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A017010204876 | NHSA |
| 福建东瑞制药有限公司 | 国药准字H20041143 | 60mg(以C15H17NaO3计) | Category B (乙) | XM01AEL283A017010304876 | 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: 3 filings and 3 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏鹏鹞药业有限公司 | CYHS2600787 | Generic | 2026/04/08 | Not stated by source | CDE |
| 山西同达药业有限公司 | CYHS2600508 | Generic | 2026/02/25 | Not stated by source | CDE |
| 大桐制药(中国)有限责任公司 | CYHS2504009 | Generic | 2025/11/19 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
Non-component matches: 21 companies with A status and 6 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 |
|---|---|---|---|---|---|---|
| 洛索洛芬钠 | 湖北迅达药业股份有限公司 | Y20260000755 | I | Exact ingredient | 2026/10/29 | CDE |
| 洛索洛芬钠 | 浙江尚泰生物制药有限公司 | Y20260000660 | I | Exact ingredient | 2026/08/28 | CDE |
| 洛索洛芬钠 | 无棣融川医药化工科技有限公司 | Y20260000514 | I | Exact ingredient | 2026/08/13 | CDE |
| 洛索洛芬钠 | 宜昌东阳光制药有限公司 | Y20250001458 | I | Exact ingredient | 2026/01/30 | CDE |
| 洛索洛芬钠 | DONGBANG FUTURE TECH & LIFE CO., LTD. | Y20240000410 | I | Exact ingredient | 2025/10/10 | CDE |
| 洛索洛芬钠 | 河南华商药业有限公司 | Y20250000238 | A | Exact ingredient | 2026/08/31 | CDE |
| 洛索洛芬钠 | KOLON LIFE SCIENCE, INC. | Y20240001168 | I | Exact ingredient | 2025/02/21 | CDE |
| 洛索洛芬钠 | 安徽鼎旺医药有限公司 | Y20240001477 | A | Exact ingredient | 2026/06/01 | CDE |
| 洛索洛芬钠 | 克洛怡制药有限公司 | Y20240001406 | A | Exact ingredient | 2026/05/07 | CDE |
| 洛索洛芬钠 | Metrochem API Private Limited | Y20240000043 | A | Exact ingredient | 2026/04/21 | CDE |
| 洛索洛芬钠 | 浙江普洛家园药业有限公司 | Y20220000630 | A | Exact ingredient | 2026/10/10 | CDE |
| 洛索洛芬钠 | 金鸿药业股份有限公司 | Y20220000512 | A | Exact ingredient | 2024/11/01 | CDE |
| 洛索洛芬钠 | 浙江司太立制药股份有限公司 | Y20220000226 | A | Exact ingredient | 2024/02/02 | CDE |
| 洛索洛芬钠 | 湖南九典宏阳制药有限公司 | Y20210001086 | A | Exact ingredient | 2025/06/28 | CDE |
| 洛索洛芬钠 | Anlon Healthcare Limited | Y20210000754 | A | Exact ingredient | 2026/08/30 | CDE |
| 洛索洛芬钠 | Daito Pharmaceutical Co., Ltd. | Y20190021419 | A | Exact ingredient | 2026/07/17 | CDE |
| 洛索洛芬钠 | SHIN POONG Pharmaceutical Co.,Ltd. | Y20190009153 | A | Exact ingredient | — | CDE |
| 洛索洛芬钠 | DAIICHI SANKYO CO.,LTD. | Y20190009069 | A | Exact ingredient | — | CDE |
| 洛索洛芬钠 | 吉林英联生物制药股份有限公司 | Y20190008486 | A | Exact ingredient | — | CDE |
| 洛索洛芬钠 | 国药集团致君(苏州)制药有限公司 | Y20190007938 | A | Exact ingredient | — | CDE |
| 洛索洛芬钠 | 福建汇天生物药业有限公司 | Y20190007830 | A | Exact ingredient | 2024/08/01 | CDE |
| 洛索洛芬钠 | 兴安药业有限公司 | Y20190007805 | A | Exact ingredient | — | CDE |
| 洛索洛芬钠 | 上海信联化学制药有限公司 | Y20190007713 | A | Exact ingredient | 2025/01/03 | CDE |
| 洛索洛芬钠 | 迪嘉药业集团股份有限公司 | Y20190007707 | A | Exact ingredient | 2026/09/29 | CDE |
| 洛索洛芬钠 | 重庆西南制药二厂有限责任公司 | Y20170002341 | A | Exact ingredient | 2024/03/14 | CDE |
| 洛索洛芬钠 | 山东罗欣药业集团恒欣药业有限公司 | Y20170002291 | A | Exact ingredient | 2024/10/24 | CDE |
| 洛索洛芬钠 | 第一三共株式会社 | Y20170001957 | A | Exact ingredient | 2019/04/22 | CDE |
| 洛索洛芬钠 | 山东罗欣药业集团恒欣药业有限公司 | Y20170000454 | A | Exact ingredient | 2023/08/18 | 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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