Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 4 applicationsNo longer listed under review: 2 applicationsSupplement delivery: 2 applications
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: 3 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 |
|---|---|---|---|---|---|---|
| 上海现代制药股份有限公司 | 上海现代制药股份有限公司 | 国药准字H20247158 | 2024/07/10 | 50mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 河北龙海药业有限公司 | 河北龙海药业有限公司 | 国药准字H20243552 | 2024/04/24 | 25mg | 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 |
| 四川科瑞德制药股份有限公司 | 四川科瑞德制药股份有限公司 | 国药准字H20234510 | 2023/11/21 | 25mg | 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 |
| 上海现代制药股份有限公司 | 上海现代制药股份有限公司 | 国药准字H20100052 | 2022/05/18 | 25mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 四川科瑞德制药股份有限公司 | 四川科瑞德制药股份有限公司 | 国药准字H20269200 | 2026/08/11 | 50mg | 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: 4 distinct approval numbers and 3 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 上海现代制药股份有限公司 | 国药准字H20100052 | 25mg | Category B (乙) | XN06AXM103A001010100814 | NHSA |
| 四川科瑞德制药股份有限公司 | 国药准字H20234510 | 25mg | Category B (乙) | XN06AXM103A001010102181 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20243552 | 25mg | Category B (乙) | XN06AXM103A001010102766 | NHSA |
| 上海现代制药股份有限公司 | 国药准字H20100052 | 25mg | Category B (乙) | XN06AXM103A001010200814 | NHSA |
| 四川科瑞德制药股份有限公司 | 国药准字H20234510 | 25mg | Category B (乙) | XN06AXM103A001010202181 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20243552 | 25mg | Category B (乙) | XN06AXM103A001010202766 | NHSA |
| 上海现代制药股份有限公司 | 国药准字H20100052 | 25mg | Category B (乙) | XN06AXM103A001010300814 | NHSA |
| 上海现代制药股份有限公司 | 国药准字H20247158 | 50mg | Category B (乙) | XN06AXM103A001020100814 | NHSA |
| 上海现代制药股份有限公司 | 国药准字H20247158 | 50mg | Category B (乙) | XN06AXM103A001020200814 | 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: 8 filings and 5 distinct first applicants.
Generic 8
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 宁波美诺华天康药业有限公司 | CYHS2602329 | Generic | 2026/09/18 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2602328 | Generic | 2026/09/18 | Not stated by source | CDE |
| 河北万龙药业有限公司;河北龙海药业股份有限公司 | CYHS2601197 | Generic | 2026/05/26 | Not stated by source | CDE |
| 河北万龙药业有限公司;河北龙海药业股份有限公司 | CYHS2601196 | Generic | 2026/05/26 | Not stated by source | CDE |
| 石家庄龙泽制药股份有限公司 | CYHS2600858 | Generic | 2026/04/14 | Not stated by source | CDE |
| 石家庄龙泽制药股份有限公司 | CYHS2600857 | Generic | 2026/04/14 | Not stated by source | CDE |
| 浙江华贝药业有限责任公司;乐普制药科技有限公司 | CYHS2600586 | Generic | 2026/02/28 | Not stated by source | CDE |
| 白云山东泰商丘药业有限公司 | CYHS2503173 | Generic | 2025/08/29 | 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 |
|---|---|---|---|---|---|
| 宁波美诺华天康药业有限公司 | CYHS2602329 | Generic | 2026/09/18 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2602328 | Generic | 2026/09/18 | Not stated by source | CDE |
| 河北万龙药业有限公司;河北龙海药业股份有限公司 | CYHS2601197 | Generic | 2026/05/26 | Not stated by source | CDE |
| 河北万龙药业有限公司;河北龙海药业股份有限公司 | CYHS2601196 | Generic | 2026/05/26 | Not stated by source | CDE |
| 石家庄龙泽制药股份有限公司 | CYHS2600858 | Generic | 2026/04/14 | Not stated by source | CDE |
| 石家庄龙泽制药股份有限公司 | CYHS2600857 | Generic | 2026/04/14 | Not stated by source | CDE |
| 浙江华贝药业有限责任公司;乐普制药科技有限公司 | CYHS2600586 | Generic | 2026/02/28 | Not stated by source | CDE |
Non-component matches: 5 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 |
|---|---|---|---|---|---|---|
| 盐酸米那普仑 | 江苏威奇达药业有限公司 | Y20240001096 | A | Exact ingredient | 2026/02/13 | CDE |
| 盐酸米那普仑 | 泸州科瑞德制药有限公司 | Y20210000829 | A | Exact ingredient | 2026/06/10 | CDE |
| 盐酸米那普仑 | Glenmark Life Sciences Limited | Y20200000968 | I | Exact ingredient | 2022/08/15 | CDE |
| 盐酸米那普仑 | Hetero Labs Limited | Y20190000779 | A | Exact ingredient | 2025/09/30 | CDE |
| 盐酸米那普仑 | 国药集团威奇达药业有限公司 | Y20190021586 | A | Exact ingredient | 2026/07/29 | CDE |
| 盐酸米那普仑 | 上海现代制药股份有限公司 | Y20190002147 | A | Exact ingredient | — | 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.
CYHB2601849
Fact date: 2026/10/27 · Site observation date: 2026/10/27
Accepted: 2026/10/09
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/27 (approval no.: —; approval date: 2026/10/23); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 16
NMPA · Table row 16 ↗ View source ↗CYHB2601848
Fact date: 2026/10/27 · Site observation date: 2026/10/27
Accepted: 2026/10/09
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/27 (approval no.: —; approval date: 2026/10/23); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 15
NMPA · Table row 15 ↗ View source ↗CYHB2601849
Fact date: 2026/10/23 · Publication date: 2026/10/27 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 16 ↗CYHB2601848
Fact date: 2026/10/23 · Publication date: 2026/10/27 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 15 ↗CYHB2601849
Fact date: 2026/10/09 · Site observation date: 2026/10/22
View source ↗CYHB2601848
Fact date: 2026/10/09 · Site observation date: 2026/10/22
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.
Free follow
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
US$200
Billed every month
US$540
Billed every three months
US$180 per month
US$1,920
Billed every year
US$160 per month
Online subscriptions are not enabled. The form below registers interest; it does not charge or activate access.
Separate one-time purchase
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
US$490
One payment · 12 months of access
Online comparison-table purchase is not enabled.
Billed by Creem, our merchant of record · Terms · Refund policy