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As of 13 November 2026, for Amorolfine Hydrochloride Cream, 9 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 3 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.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
Catalogue holders0View records ↓
Under-review filings9View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers5View 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: 5 distinct approval numbers and 5 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H20133066 | 0.25% | Category B | XD01AEA039F002010101438 | NHSA |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H20249772 | See source | Category B | XD01AEA039F002010101955 | NHSA |
| Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | 国药准字H20264638 | See source | Category B | XD01AEA039F002010110137 | NHSA |
| GALDERMA LABORATORIUM GmbH | 国药准字HJ20140118 | 0.25% | Category B | XD01AEA039F002010178443 | NHSA |
| Suzhou Gao Mai Pharma Co., Ltd. romanized | 国药准字H20264839 | See source | Category B | XD01AEA039F002010184410 | NHSA |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H20133066 | 0.25% | Category B | XD01AEA039F002020101438 | NHSA |
| Wuhan Nuo An Pharma Co., Ltd. romanized | 国药准字H20249772 | See source | Category B | XD01AEA039F002020101955 | NHSA |
| Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized | 国药准字H20264638 | See source | Category B | XD01AEA039F002020110137 | NHSA |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H20133066 | 0.25% | Category B | XD01AEA039F002030101438 | NHSA |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H20133066 | 0.25% | Category B | XD01AEA039F002040101438 | NHSA |
| Jiangsu Fu Bang Pharma Co., Ltd. romanized | 国药准字H20133066 | 0.25% | Category B | XD01AEA039F002050101438 | 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: 9 filings and 7 distinct first applicants.
Supplement 3 · Generic 6
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Galderma Laboratorium GmbH; Laboratoires Galderma | JYHB2600484 | Supplement | 2026/08/20 | Not stated by source | CDE |
| Fu Yuan Pharma Co., Ltd. romanized | CYHS2602031 | Generic | 2026/08/17 | Not stated by source | CDE |
| Name not romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2601418 | Generic | 2026/06/16 | Not stated by source | CDE |
| Jiangxi Zhong Ze Yuan Pharmaceuticals Technology Co., Ltd. romanized; Hunan Pai Ge Lan Pharma Co., Ltd. romanized | CYHS2600605 | Generic | 2026/03/02 | Not stated by source | CDE |
| Wuhan Nuo An Pharma Co., Ltd. romanized | CYHB2600279 | Supplement | 2026/02/07 | Not stated by source | CDE |
| Wuhan Nuo An Pharma Co., Ltd. romanized | CYHB2600277 | Supplement | 2026/02/07 | Not stated by source | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2600133 | Generic | 2026/01/10 | Not stated by source | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2600132 | Generic | 2026/01/10 | Not stated by source | CDE |
| Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized | CYHS2602706 | Generic | 2026/11/05 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 6 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Fu Yuan Pharma Co., Ltd. romanized | CYHS2602031 | Generic | 2026/08/17 | Not stated by source | CDE |
| Name not romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CYHS2601418 | Generic | 2026/06/16 | Not stated by source | CDE |
| Jiangxi Zhong Ze Yuan Pharmaceuticals Technology Co., Ltd. romanized; Hunan Pai Ge Lan Pharma Co., Ltd. romanized | CYHS2600605 | Generic | 2026/03/02 | Not stated by source | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2600133 | Generic | 2026/01/10 | Not stated by source | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2600132 | Generic | 2026/01/10 | Not stated by source | CDE |
| Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized | CYHS2602706 | Generic | 2026/11/05 | 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 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20230000424 | A | Exact ingredient | 2026/06/06 | CDE |
| 盐酸阿莫罗芬 · No verified English name | Yi Chang Nuo An Pharmaceutical Co., Ltd. romanized | Y20230000331 | A | Exact ingredient | 2025/01/04 | CDE |
| 盐酸阿莫罗芬 · No verified English name | Anhui Yong Sheng Tang Pharma Co., Ltd. romanized | Y20220000665 | A | Exact ingredient | 2024/04/16 | CDE |
| 盐酸阿莫罗芬 · No verified English name | PHARMASYNTHESE | Y20200000861 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸阿莫罗芬 · No verified English name | Zhejiang Hai Xiang Pharma Co., Ltd. romanized | 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/11/05Accepted
Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized
CYHS2602706
Fact date: 2026/11/05 · Site observation date: 2026/11/06
View source ↗ -
2026/08/20Accepted
Galderma Laboratorium GmbH; Laboratoires Galderma
JYHB2600484
Fact date: 2026/08/20 · Site observation date: 2026/10/22
View source ↗ -
2026/08/17Accepted
Fu Yuan Pharma Co., Ltd. romanized
CYHS2602031
Fact date: 2026/08/17 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
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: 2026/11/13 06:41
- 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: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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