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: 4 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 2 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H20264292 | 2026/05/12 | 100mg(按C23H27N3O7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 |
| 北京诚济制药股份有限公司 | 北京诚济制药股份有限公司 | 国药准字H20264306 | 2026/05/12 | 100mg(按C23H27N3O7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 |
| 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H20264293 | 2026/05/12 | 50mg(按C23H27N3O7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 |
| 海口市制药厂有限公司 | 海口市制药厂有限公司 | 国药准字H10920124 | 2023/03/02 | 50mg(按C23H27N3O7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 |
| — | 瀚晖制药有限公司 | 国药准字H20174080 | 1994/12/02 | 50mg(按C23H27N3O7计) | Other drug (其他药品) | CDE |
| — | 瀚晖制药有限公司 | 国药准字H20174081 | 1994/12/02 | 100mg(按C23H27N3O7计) | 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: 16 distinct approval numbers and 13 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 广州白云山光华制药股份有限公司 | 国药准字H44020434 | 按C23H27N3O7计算50mg | Category B (乙) | XJ01AAM106E001010100372 | NHSA |
| 深圳市中联制药有限公司 | 国药准字H10940184 | 按C23H27N3O7计50mg | Category B (乙) | XJ01AAM106E001010100543 | NHSA |
| 上海美优制药有限公司 | 国药准字H10950348 | 按C23H27N307计50mg | Category B (乙) | XJ01AAM106E001010100727 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H10940285 | 按C23H27N3O7计 50mg | Category B (乙) | XJ01AAM106E001010101016 | NHSA |
| 华北制药股份有限公司 | 国药准字H20123310 | 50mg | Category B (乙) | XJ01AAM106E001010102690 | NHSA |
| 华北制药股份有限公司 | 国药准字H20010439 | 按C23H27N3O7计100mg | Category B (乙) | XJ01AAM106E001010102697 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010104339 | NHSA |
| 上海华源安徽仁济制药有限公司 | 国药准字H20083474 | 50mg(按C23H27N3O7计) | Category B (乙) | XJ01AAM106E001010104436 | NHSA |
| 昆药集团股份有限公司 | 国药准字H10940017 | 按C23H27N3O7计算50mg | Category B (乙) | XJ01AAM106E001010105614 | NHSA |
| 海口市制药厂有限公司 | 国药准字H10920124 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010105758 | NHSA |
| 瀚晖制药有限公司 | 国药准字H20174081 | 100mg(按C23H27N3O7计) | Category B (乙) | XJ01AAM106E001010109853 | NHSA |
| 北京诚济制药股份有限公司 | 国药准字H20264306 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010182209 | NHSA |
| 上海美优制药有限公司 | 国药准字H10950348 | 按C23H27N307计50mg | Category B (乙) | XJ01AAM106E001010200727 | NHSA |
| 德全药品(江苏)股份有限公司 | 国药准字H20059110 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010201751 | NHSA |
| 华北制药股份有限公司 | 国药准字H20123310 | 50mg | Category B (乙) | XJ01AAM106E001010202690 | NHSA |
| 哈药集团制药六厂 | 国药准字H10940059 | 50mg | Category B (乙) | XJ01AAM106E001010203711 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010204339 | NHSA |
| 上海华源安徽仁济制药有限公司 | 国药准字H20083474 | 50mg(按C23H27N3O7计) | Category B (乙) | XJ01AAM106E001010204436 | NHSA |
| 海口市制药厂有限公司 | 国药准字H10920124 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010205758 | NHSA |
| 德全药品(江苏)股份有限公司 | 国药准字H20059110 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010301751 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010304339 | NHSA |
| 上海华源安徽仁济制药有限公司 | 国药准字H20083474 | 50mg(按C23H27N3O7计) | Category B (乙) | XJ01AAM106E001010304436 | NHSA |
| 德全药品(江苏)股份有限公司 | 国药准字H20059110 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010401751 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010404339 | NHSA |
| 上海华源安徽仁济制药有限公司 | 国药准字H20083474 | 50mg(按C23H27N3O7计) | Category B (乙) | XJ01AAM106E001010404436 | NHSA |
| 德全药品(江苏)股份有限公司 | 国药准字H20059110 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010501751 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010504339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010604339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010704339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010804339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001010904339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001011004339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001011104339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001011204339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001011304339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001011404339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001011504339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264293 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001011604339 | NHSA |
| 德全药品(江苏)股份有限公司 | 国药准字H20059110 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020101751 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020104339 | NHSA |
| 海口市制药厂有限公司 | 国药准字H10920124 | 50mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020105758 | NHSA |
| 瀚晖制药有限公司 | 国药准字H20174080 | 50mg(按C23H27N3O7计) | Category B (乙) | XJ01AAM106E001020109853 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020204339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020304339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020404339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020504339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020604339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020704339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020804339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001020904339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001021004339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001021104339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001021204339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001021304339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001021404339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001021504339 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20264292 | 100mg(按C₂₃H₂₇N₃O₇计) | Category B (乙) | XJ01AAM106E001021604339 | 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: 19 filings and 11 distinct first applicants.
Supplement 4 · Generic 15
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 德全药品(江苏)股份有限公司 | CYHB2650007 | Supplement | 2026/01/07 | Not stated by source | CDE |
| 德全药品(江苏)股份有限公司 | CYHB2650006 | Supplement | 2026/01/07 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHB2650173 | Supplement | 2026/08/12 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHB2650172 | Supplement | 2026/08/12 | Not stated by source | CDE |
| 浙江创新生物有限公司 | CYHS2600462 | Generic | 2026/02/13 | Not stated by source | CDE |
| 浙江创新生物有限公司 | CYHS2600461 | Generic | 2026/02/13 | Not stated by source | CDE |
| 石家庄康力药业有限公司 | CYHS2600307 | Generic | 2026/01/29 | Not stated by source | CDE |
| 福安药业集团宁波天衡制药有限公司 | CYHS2600165 | Generic | 2026/01/13 | Not stated by source | CDE |
| 福安药业集团宁波天衡制药有限公司 | CYHS2600164 | Generic | 2026/01/13 | Not stated by source | CDE |
| 珠海同源药业有限公司 | CYHS2600083 | Generic | 2026/01/08 | Not stated by source | CDE |
| 珠海同源药业有限公司 | CYHS2600082 | Generic | 2026/01/08 | Not stated by source | CDE |
| 成都瑞尔医药科技有限公司;杭州民生药业股份有限公司 | CYHS2503409 | Generic | 2025/09/16 | Not stated by source | CDE |
| 成都瑞尔医药科技有限公司;杭州民生药业股份有限公司 | CYHS2503408 | Generic | 2025/09/16 | Not stated by source | CDE |
| 安徽杰玺医药有限公司 | CYHS2503324 | Generic | 2025/09/09 | Not stated by source | CDE |
| 安徽杰玺医药有限公司 | CYHS2503323 | Generic | 2025/09/09 | Not stated by source | CDE |
| 北京海步医药科技有限公司;北京亚宝生物药业有限公司 | CYHS2503233 | Generic | 2025/09/02 | Not stated by source | CDE |
| 杭州和康药业有限公司 | CYHS2501367 | Generic | 2025/04/09 | Not stated by source | CDE |
| 杭州和康药业有限公司 | CYHS2501366 | Generic | 2025/04/09 | Not stated by source | CDE |
| 浙江华海制药科技有限公司 | CYHS2500237 | Generic | 2025/01/10 | Not stated by source | CDE |
Loaded records: 7 filings and 4 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 浙江创新生物有限公司 | CYHS2600462 | Generic | 2026/02/13 | Not stated by source | CDE |
| 浙江创新生物有限公司 | CYHS2600461 | Generic | 2026/02/13 | Not stated by source | CDE |
| 石家庄康力药业有限公司 | CYHS2600307 | Generic | 2026/01/29 | Not stated by source | CDE |
| 福安药业集团宁波天衡制药有限公司 | CYHS2600165 | Generic | 2026/01/13 | Not stated by source | CDE |
| 福安药业集团宁波天衡制药有限公司 | CYHS2600164 | Generic | 2026/01/13 | Not stated by source | CDE |
| 珠海同源药业有限公司 | CYHS2600083 | Generic | 2026/01/08 | Not stated by source | CDE |
| 珠海同源药业有限公司 | CYHS2600082 | Generic | 2026/01/08 | Not stated by source | CDE |
Non-component matches: 6 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 |
|---|---|---|---|---|---|---|
| 盐酸米诺环素 | 海正药业南通有限公司 | Y20240000032 | A | Exact ingredient | 2026/09/29 | CDE |
| 盐酸米诺环素 | HOVIONE FARMACIENCIA S.A. | Y20230000723 | A | Exact ingredient | 2025/10/14 | CDE |
| 盐酸米诺环素 | 浙江昌海制药有限公司 | Y20220000076 | A | Exact ingredient | 2025/09/09 | CDE |
| 盐酸米诺环素 | CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS, S.A. | Y20210000751 | A | Exact ingredient | 2024/07/26 | CDE |
| 盐酸米诺环素 | HOVIONE FARMACIENCIA S.A. | Y20200000691 | I | Exact ingredient | 2020/08/03 | CDE |
| 盐酸米诺环素 | CURIA ITALY S.R.L. | Y20190008989 | A | Exact ingredient | 2026/09/03 | CDE |
| 盐酸米诺环素 | 华北制药华胜有限公司 | Y20190004294 | A | Exact ingredient | 2024/10/01 | 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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