Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 5 applicationsNo longer listed under review: 4 applicationsSupplement delivery: 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: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 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 |
|---|---|---|---|---|---|---|
| LEO Pharma A/S | LEO Laboratories Limited | H20130921 | 1999/10/29 | 以C31H48O6计算,15g:0.3g | 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: 23 distinct approval numbers and 19 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 重庆华邦制药有限公司 | 国药准字H20254572 | 2%(15g:0.3g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002010101003 | NHSA |
| 湖北科益药业股份有限公司 | 国药准字H20255708 | 2%(15g:0.3g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002010101828 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20264603 | 2%(15g:0.3g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002010102180 | NHSA |
| 华东医药(西安)博华制药有限公司 | 国药准字H20249267 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002010102469 | NHSA |
| 河北新张药股份有限公司 | 国药准字H20265788 | 2%(15g:0.3g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002010102673 | NHSA |
| 杭州朱养心药业有限公司 | 国药准字H20265420 | 2%(15g:0.3g,按C₃₁H₄₈O₆ 计) | Category B (乙) | XD06AXF045F002010104522 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20264675 | 2%(10g:0.2g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002010105356 | NHSA |
| 丽彩甘肃西峰制药有限公司 | 国药准字H20243460 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002010109579 | NHSA |
| LEO Pharma A/S | 国药准字HJ20130921 | 以C₃₁H₄₈O₆计算,15g:0.3g | Category B (乙) | XD06AXF045F002010179051 | NHSA |
| 澳美制药厂有限公司 | 国药准字HC20150044 | 2%(5g:0.1g,按C₃₁H₄₈O₆计),2%(20g:0.4g,按 | Category B (乙) | XD06AXF045F002010179136 | NHSA |
| 福元药业有限公司 | 国药准字H20243096 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002010180651 | NHSA |
| 湖北成田药业有限公司 | 国药准字H20255362 | 2%(15g:0.3g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002010180999 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H20264926 | 2%(15g:0.3g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002010181475 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20263206 | 2%(15g:0.3g,按C₃₁H₄₈O₆ 计) | Category B (乙) | XD06AXF045F002010184211 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20254526 | 2%(15g:0.3g,按C₃₁H₄₈O₆ 计) | Category B (乙) | XD06AXF045F002010184221 | NHSA |
| 浙江众延医药科技有限公司 | 国药准字H20255990 | 2%(15g:0.3g,按C₃₁H₄₈O₆ 计) | Category B (乙) | XD06AXF045F002010184225 | NHSA |
| 东阳祥昇医药科技有限公司 | 国药准字H20265663 | 2%(15g:0.3g,按C31H48O6计) | Category B (乙) | XD06AXF045F002010184294 | NHSA |
| 西藏奥斯必秀医药有限公司 | 国药准字H20265202 | 2%(15g:0.3g,按C₃₁H₄₈O₆ 计) | Category B (乙) | XD06AXF045F002010184724 | NHSA |
| 漳州水仙药业股份有限公司 | 国药准字H20254944 | 2%(15g:0.3g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002010185291 | NHSA |
| 湖北科益药业股份有限公司 | 国药准字H20255708 | 2%(15g:0.3g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002010201828 | NHSA |
| 华东医药(西安)博华制药有限公司 | 国药准字H20249267 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002010202469 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20263206 | 2%(15g:0.3g,按C₃₁H₄₈O₆ 计) | Category B (乙) | XD06AXF045F002010284211 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20254526 | 2%(15g:0.3g,按C₃₁H₄₈O₆ 计) | Category B (乙) | XD06AXF045F002010284221 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20263206 | 2%(15g:0.3g,按C₃₁H₄₈O₆ 计) | Category B (乙) | XD06AXF045F002010384211 | NHSA |
| 华东医药(西安)博华制药有限公司 | 国药准字H20249267 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002020102469 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20264676 | 2%(15g:0.3g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002020105356 | NHSA |
| 丽彩甘肃西峰制药有限公司 | 国药准字H20243460 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002020109579 | NHSA |
| 澳美制药厂有限公司 | 国药准字HC20150044 | 2%(5g:0.1g,按C₃₁H₄₈O₆计),2%(20g:0.4g,按 | Category B (乙) | XD06AXF045F002020179136 | NHSA |
| 福元药业有限公司 | 国药准字H20243096 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002020180651 | NHSA |
| 华东医药(西安)博华制药有限公司 | 国药准字H20249267 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002030102469 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20264674 | 2%(5g:0.1g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002030105356 | NHSA |
| 澳美制药厂有限公司 | 国药准字HC20150043 | 2%(5g:0.1g,按C₃₁H₄₈O₆计),2%(20g:0.4g,按 | Category B (乙) | XD06AXF045F002030179136 | NHSA |
| 福元药业有限公司 | 国药准字H20243096 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002030180651 | NHSA |
| 华东医药(西安)博华制药有限公司 | 国药准字H20249267 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002040102469 | NHSA |
| 福元药业有限公司 | 国药准字H20269140 | 2%(10g:0.2g,按C₃₁H₄₈O₆计) | Category B (乙) | XD06AXF045F002040180651 | NHSA |
| 华东医药(西安)博华制药有限公司 | 国药准字H20249267 | 以C₃₁H₄₈O₆计算,2%(15g:0.3g) | Category B (乙) | XD06AXF045F002040202469 | NHSA |
| 澳美制药厂有限公司 | 国药准字HC20150043 | 2%(5g:0.1g,按C₃₁H₄₈O₆计),2%(20g:0.4g,按 | Category B (乙) | XD06AXF045F002050179136 | NHSA |
| 澳美制药厂有限公司 | 国药准字HC20150044 | 2%(5g:0.1g,按C₃₁H₄₈O₆计),2%(20g:0.4g,按 | Category B (乙) | XD06AXF045F002060179136 | 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: 15 filings and 15 distinct first applicants.
Generic 14 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海纳制药有限公司 | CYHS2602426 | Generic | 2026/09/29 | Not stated by source | CDE |
| 哈尔滨葵花药业有限公司;江苏知原药业股份有限公司 | CYHS2503853 | Generic | 2025/11/03 | Not stated by source | CDE |
| 山东诺明康药物研究院有限公司;药源生物科技(启东)有限公司 | CYHS2503809 | Generic | 2025/10/28 | Not stated by source | CDE |
| 武汉市小铂生物科技有限公司 | CYHS2602563 | Generic | 2026/10/19 | Not stated by source | CDE |
| 河南大新药业有限公司 | CYHS2602156 | Generic | 2026/08/28 | Not stated by source | CDE |
| 重庆华邦制药有限公司 | CYHB2601643 | Supplement | 2026/08/27 | Not stated by source | CDE |
| 哈药集团生物工程有限公司 | CYHS2601936 | Generic | 2026/08/07 | Not stated by source | CDE |
| 浙江普利药业有限公司 | CYHS2601022 | Generic | 2026/04/30 | Not stated by source | CDE |
| 湖北午时药业股份有限公司 | CYHS2600642 | Generic | 2026/03/11 | Not stated by source | CDE |
| 山西泽辰医药科技有限公司;湖南九典制药股份有限公司 | CYHS2600470 | Generic | 2026/02/13 | Not stated by source | CDE |
| 山东明仁福瑞达制药股份有限公司 | CYHS2600141 | Generic | 2026/01/10 | Not stated by source | CDE |
| 浙江华海药业股份有限公司 | CYHS2504362 | Generic | 2025/12/23 | Not stated by source | CDE |
| 浙江核力欣健药业有限公司;杭州万邦天诚药业有限公司 | CYHS2503600 | Generic | 2025/10/09 | Not stated by source | CDE |
| 北京普祺医药科技股份有限公司;赤峰赛林泰药业有限公司 | CYHS2503319 | Generic | 2025/09/09 | Not stated by source | CDE |
| 上海朝晖药业有限公司 | CYHS2503100 | Generic | 2025/08/23 | Not stated by source | CDE |
Loaded records: 8 filings and 8 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海纳制药有限公司 | CYHS2602426 | Generic | 2026/09/29 | Not stated by source | CDE |
| 武汉市小铂生物科技有限公司 | CYHS2602563 | Generic | 2026/10/19 | Not stated by source | CDE |
| 河南大新药业有限公司 | CYHS2602156 | Generic | 2026/08/28 | Not stated by source | CDE |
| 哈药集团生物工程有限公司 | CYHS2601936 | Generic | 2026/08/07 | Not stated by source | CDE |
| 浙江普利药业有限公司 | CYHS2601022 | Generic | 2026/04/30 | Not stated by source | CDE |
| 湖北午时药业股份有限公司 | CYHS2600642 | Generic | 2026/03/11 | Not stated by source | CDE |
| 山西泽辰医药科技有限公司;湖南九典制药股份有限公司 | CYHS2600470 | Generic | 2026/02/13 | Not stated by source | CDE |
| 山东明仁福瑞达制药股份有限公司 | CYHS2600141 | Generic | 2026/01/10 | Not stated by source | CDE |
Non-component matches: 7 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 |
|---|---|---|---|---|---|---|
| 夫西地酸 | 山东格得生物科技有限公司 | Y20250000621 | I | Exact ingredient | 2025/09/29 | CDE |
| 夫西地酸钠 | 福建康鸿生物科技有限公司 | Y20230000633 | A | Salt-normalized ingredient | 2026/10/20 | CDE |
| 夫西地酸 | 福建康鸿生物科技有限公司 | Y20230000307 | A | Exact ingredient | 2026/10/20 | CDE |
| 夫西地酸钠 | 江苏九阳生物制药有限公司 | Y20220001182 | A | Salt-normalized ingredient | 2024/07/23 | CDE |
| 夫西地酸钠 | ERCROS S.A. | Y20190009179 | A | Salt-normalized ingredient | 2023/03/24 | CDE |
| 夫西地酸钠 | ERCROS S.A. | Y20190009178 | A | Salt-normalized ingredient | 2023/03/24 | CDE |
| 夫西地酸钠 | 山西振东泰盛制药有限公司 | Y20190007204 | A | Salt-normalized ingredient | 2023/05/25 | CDE |
| 夫西地酸钠 | 四川青木制药有限公司 | Y20190005952 | A | Salt-normalized ingredient | 2025/10/30 | CDE |
| 夫西地酸钠 | 海思科制药(眉山)有限公司 | Y20190004045 | A | Salt-normalized ingredient | 2025/06/14 | CDE |
| 夫西地酸钠 | LEO Pharma A/S | Y20170001447 | A | Salt-normalized ingredient | 2024/11/19 | CDE |
| 夫西地酸 | LEO Pharma A/S | Y20170001446 | A | Exact ingredient | 2024/11/12 | CDE |
| 夫西地酸 | 江苏九阳生物制药有限公司 | Y20170001361 | A | Exact ingredient | 2025/10/27 | 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.
CYHB2601887
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2026/10/14
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/06 (approval no.: —; approval date: 2026/11/05); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 38
NMPA · Table row 38 ↗ View source ↗CYHB2601887
Fact date: 2026/11/05 · Publication date: 2026/11/06 · Site observation date: 2026/11/06
Supplemental application; excluded from new marketing approvals.
View source · Table row 38 ↗JYHS2500047
Fact date: 2026/10/29 · Site observation date: 2026/10/29
Accepted: 2025/12/13
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2501247
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/04/03
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHS2501246
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/04/03
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗CYHB2601887
Fact date: 2026/10/14 · Site observation date: 2026/10/21
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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