Monthly
US$200
Billed every month
盐酸阿莫罗芬搽剂
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 3 applicationsNo longer listed under review: 1 applicationSupplement delivery: 2 applications
Current coverage may be incomplete
Which companies are listed, and at what stages?
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.
Catalogue holders0View records ↓
Under-review filings10View records ↓
This year’s generic filers6View records ↓
NHSA approval numbers17View records ↓
API companies with A status5View records ↓
Chemical-drug catalogue
Loaded records: 0 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 |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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.
NHSA drug codes
Loaded records: 17 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 杭州呋欧医药科技有限公司 | 国药准字H20263147 | 5%(5ml:250mg,按 C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010100500 | NHSA |
| 江苏福邦药业有限公司 | 国药准字H20123162 | 5%(以阿莫罗芬计) | Not stated by source | XD01AEA039T001010101438 | NHSA |
| 湖北恒安芙林药业股份有限公司 | 国药准字H20183363 | 5%(按C21H35NO计) | Not stated by source | XD01AEA039T001010101808 | NHSA |
| 远大医药(仙桃)制药有限公司 | 国药准字H20263166 | 5%(2.5ml:125mg,按C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010101862 | NHSA |
| 武汉诺安药业有限公司 | 国药准字H20253230 | 5%(2.5ml:125mg)(按 C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010101955 | NHSA |
| 合肥启旸生物医药科技有限公司 | 国药准字H20263456 | 5%(2.5ml:125mg,按C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010104388 | NHSA |
| 浙江迪耳药业有限公司 | 国药准字H20065886 | 2.5ml:0.125g(以阿莫罗芬计) | Not stated by source | XD01AEA039T001010104623 | NHSA |
| 江苏盈科生物制药有限公司 | 国药准字H20255482 | 5%(2.5ml:125mg,按C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010110137 | NHSA |
| Galderma International | 国药准字HJ20181200 | 5%(以阿莫罗芬计,g/ml) | Not stated by source | XD01AEA039T001010178442 | NHSA |
| 福元药业有限公司 | 国药准字H20254685 | 5%(2.5ml:125mg,按C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010180651 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H20254777 | 5%(2.5ml:125mg)(按C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010181475 | NHSA |
| 景时(杭州)药业有限公司 | 国药准字H20263470 | 5%(2.5ml:125mg,按 C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010183975 | NHSA |
| 药探探(武汉)药业有限公司 | 国药准字H20254474 | 5%(5ml:250mg)(按C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010184160 | NHSA |
| 浙江寰领医药科技有限公司 | 国药准字H20255326 | 5%(2.5ml:125mg)(按C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010184239 | NHSA |
| 湖南及正医药科技有限公司 | 国药准字H20263135 | 5%(5ml:250mg,按 C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010184994 | NHSA |
| 武汉诺安药业有限公司 | 国药准字H20253230 | 5%(2.5ml:125mg)(按 C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010201955 | NHSA |
| 合肥启旸生物医药科技有限公司 | 国药准字H20263456 | 5%(2.5ml:125mg,按C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001010204388 | NHSA |
| 浙江迪耳药业有限公司 | 国药准字H20065886 | 2.5ml:0.125g(以阿莫罗芬计) | Not stated by source | XD01AEA039T001010204623 | NHSA |
| 江苏福邦药业有限公司 | 国药准字H20123162 | 5%(以阿莫罗芬计) | Not stated by source | XD01AEA039T001020101438 | NHSA |
| 湖北恒安芙林药业股份有限公司 | 国药准字H20183363 | 5%(按C21H35NO计) | Not stated by source | XD01AEA039T001020101808 | NHSA |
| 武汉诺安药业有限公司 | 国药准字H20253230 | 5%(2.5ml:125mg)(按 C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001020101955 | NHSA |
| 江苏盈科生物制药有限公司 | 国药准字H20255482 | 5%(2.5ml:125mg,按C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001020110137 | NHSA |
| 国铭制药(海南)有限公司 | 国药准字H20264117 | 5%(2.5ml:0.125g,按 C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001020184160 | NHSA |
| 国铭制药(海南)有限公司 | 国药准字H20264117 | 5%(2.5ml:0.125g,按 C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001020284160 | NHSA |
| 江苏福邦药业有限公司 | 国药准字H20123162 | 5%(以阿莫罗芬计) | Not stated by source | XD01AEA039T001030101438 | NHSA |
| 湖北恒安芙林药业股份有限公司 | 国药准字H20183363 | 5%(按C21H35NO计) | Not stated by source | XD01AEA039T001030101808 | NHSA |
| 武汉诺安药业有限公司 | 国药准字H20269194 | 5%(5ml:250mg)(按 C₂₁H₃₅NO计) | Not stated by source | XD01AEA039T001030101955 | NHSA |
| 江苏福邦药业有限公司 | 国药准字H20123162 | 5%(以阿莫罗芬计) | Not stated by source | XD01AEA039T001040101438 | NHSA |
| 湖北恒安芙林药业股份有限公司 | 国药准字H20183363 | 5%(按C21H35NO计) | Not stated by source | XD01AEA039T001040101808 | NHSA |
| 江苏福邦药业有限公司 | 国药准字H20123162 | 5%(以阿莫罗芬计) | Not stated by source | XD01AEA039T001050101438 | NHSA |
| 湖北恒安芙林药业股份有限公司 | 国药准字H20183363 | 5%(按C21H35NO计) | Not stated by source | XD01AEA039T001050101808 | NHSA |
| 湖北恒安芙林药业股份有限公司 | 国药准字H20183363 | 5%(按C21H35NO计) | Not stated by source | XD01AEA039T001060101808 | NHSA |
| 湖北恒安芙林药业股份有限公司 | 国药准字H20183363 | 5%(按C21H35NO计) | Not stated by source | XD01AEA039T001070101808 | 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.
Current under-review applications
Loaded records: 10 filings and 9 distinct first applicants.
Generic 10
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏晨牌邦德药业有限公司 | CYHS2601945 | Generic | 2026/08/10 | Not stated by source | CDE |
| 山西同达药业有限公司;浙江赛默制药有限公司 | CYHS2602275 | Generic | 2026/09/15 | Not stated by source | CDE |
| 乐泰药业（海南）有限公司 | CYHS2602226 | Generic | 2026/09/07 | Not stated by source | CDE |
| 杭州万邦天诚药业有限公司 | CYHS2602002 | Generic | 2026/08/13 | Not stated by source | CDE |
| 湖南状元制药有限公司;广东科泓药业有限公司 | CYHS2601172 | Generic | 2026/05/18 | Not stated by source | CDE |
| 湖南状元制药有限公司;广东科泓药业有限公司 | CYHS2601171 | Generic | 2026/05/18 | Not stated by source | CDE |
| 辰光（天津）制药有限公司 | CYHS2600028 | Generic | 2026/01/05 | Not stated by source | CDE |
| 海南诚锐生物科技有限公司;武汉诺安药业有限公司 | CYHS2503997 | Generic | 2025/11/18 | Not stated by source | CDE |
| 广州乐宓医药科技有限公司;浙江赛默制药有限公司 | CYHS2503428 | Generic | 2025/09/16 | Not stated by source | CDE |
| 中山万汉制药有限公司 | CYHS2503183 | Generic | 2025/08/30 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 7 filings and 6 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏晨牌邦德药业有限公司 | CYHS2601945 | Generic | 2026/08/10 | Not stated by source | CDE |
| 山西同达药业有限公司;浙江赛默制药有限公司 | CYHS2602275 | Generic | 2026/09/15 | Not stated by source | CDE |
| 乐泰药业（海南）有限公司 | CYHS2602226 | Generic | 2026/09/07 | Not stated by source | CDE |
| 杭州万邦天诚药业有限公司 | CYHS2602002 | Generic | 2026/08/13 | Not stated by source | CDE |
| 湖南状元制药有限公司;广东科泓药业有限公司 | CYHS2601172 | Generic | 2026/05/18 | Not stated by source | CDE |
| 湖南状元制药有限公司;广东科泓药业有限公司 | CYHS2601171 | Generic | 2026/05/18 | Not stated by source | CDE |
| 辰光（天津）制药有限公司 | CYHS2600028 | Generic | 2026/01/05 | Not stated by source | CDE |
API registrations
Non-component matches: 5 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| 盐酸阿莫罗芬 | 浙江赛默制药有限公司 | Y20230000424 | A | Exact ingredient | 2026/06/06 | CDE |
| 盐酸阿莫罗芬 | 宜昌诺安制药有限公司 | Y20230000331 | A | Exact ingredient | 2025/01/04 | CDE |
| 盐酸阿莫罗芬 | 安徽永生堂药业有限责任公司 | Y20220000665 | A | Exact ingredient | 2024/04/16 | CDE |
| 盐酸阿莫罗芬 | PHARMASYNTHESE | Y20200000861 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸阿莫罗芬 | 浙江海翔药业股份有限公司 | Y20190009340 | A | Exact ingredient | 2025/03/18 | 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.
What changed recently?
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.
-
2026/11/03Marketing application approved
湖北午时药业股份有限公司
CYHS2501000 · 国药准字H20266444
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 37 ↗ -
2026/10/27No longer listed under review
Galderma International;Laboratories Galderma
JYHB2400556
Fact date: 2026/10/27 · Site observation date: 2026/10/27
Accepted: 2024/10/22
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/23Supplement delivery
科医国际贸易（上海）有限公司
JYHB2400556
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 66 ↗ -
2026/10/19Supplement delivery
武汉诺安药业有限公司
CYHB2502336 · 国药准字H20269254
Fact date: 2026/10/19 · Publication date: 2026/10/20 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 2 ↗ -
2026/09/15Accepted
山西同达药业有限公司;浙江赛默制药有限公司
CYHS2602275
Fact date: 2026/09/15 · Site observation date: 2026/10/22
View source ↗ -
2026/09/07Accepted
-
2026/08/13Accepted
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/10 07:27
- Chemical-drug catalogue
- Last successful update: 2026/11/10 07:23
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.
- Full API register
- Last successful update: 2026/11/10 07:25
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
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.
- NMPA drug delivery notices
- Last successful update: 2026/11/10 18:31
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.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/10 08:10 · Current coverage may be incomplete
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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