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As of 13 November 2026, for Fusidic Acid Cream, 15 applications are listed as under review at China's CDE; 8 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.
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
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 holders1View records ↓
Under-review filings15View records ↓
This year’s generic filers8View records ↓
NHSA approval numbers23View records ↓
API companies with A status7View records ↓
Chemical-drug catalogue
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 | See source | Imported originator drug | 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.
NHSA drug codes
Loaded records: 23 distinct approval numbers and 19 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Chongqing Huapont Pharmaceutical Co., Ltd. | 国药准字H20254572 | See source | Category B | XD06AXF045F002010101003 | NHSA |
| Hubei Ke Yi Pharma Co., Ltd. romanized | 国药准字H20255708 | See source | Category B | XD06AXF045F002010101828 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20264603 | See source | Category B | XD06AXF045F002010102180 | NHSA |
| Hua Dong Pharmaceuticals (Xian) Bo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20249267 | See source | Category B | XD06AXF045F002010102469 | NHSA |
| Hebei Xin Zhang Yao Co., Ltd. romanized | 国药准字H20265788 | See source | Category B | XD06AXF045F002010102673 | NHSA |
| Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | 国药准字H20265420 | See source | Category B | XD06AXF045F002010104522 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20264675 | See source | Category B | XD06AXF045F002010105356 | NHSA |
| Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20243460 | See source | Category B | XD06AXF045F002010109579 | NHSA |
| LEO Pharma A/S | 国药准字HJ20130921 | See source | Category B | XD06AXF045F002010179051 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20150044 | See source | Category B | XD06AXF045F002010179136 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20243096 | See source | Category B | XD06AXF045F002010180651 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20255362 | See source | Category B | XD06AXF045F002010180999 | NHSA |
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | 国药准字H20264926 | See source | Category B | XD06AXF045F002010181475 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263206 | See source | Category B | XD06AXF045F002010184211 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254526 | See source | Category B | XD06AXF045F002010184221 | NHSA |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255990 | See source | Category B | XD06AXF045F002010184225 | NHSA |
| Name not romanized | 国药准字H20265663 | See source | Category B | XD06AXF045F002010184294 | NHSA |
| Xizang Ao Si Bi Xiu Pharmaceuticals Co., Ltd. romanized | 国药准字H20265202 | See source | Category B | XD06AXF045F002010184724 | NHSA |
| Zhang Zhou Shui Xian Pharma Co., Ltd. romanized | 国药准字H20254944 | See source | Category B | XD06AXF045F002010185291 | NHSA |
| Hubei Ke Yi Pharma Co., Ltd. romanized | 国药准字H20255708 | See source | Category B | XD06AXF045F002010201828 | NHSA |
| Hua Dong Pharmaceuticals (Xian) Bo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20249267 | See source | Category B | XD06AXF045F002010202469 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263206 | See source | Category B | XD06AXF045F002010284211 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254526 | See source | Category B | XD06AXF045F002010284221 | NHSA |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263206 | See source | Category B | XD06AXF045F002010384211 | NHSA |
| Hua Dong Pharmaceuticals (Xian) Bo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20249267 | See source | Category B | XD06AXF045F002020102469 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20264676 | See source | Category B | XD06AXF045F002020105356 | NHSA |
| Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20243460 | See source | Category B | XD06AXF045F002020109579 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20150044 | See source | Category B | XD06AXF045F002020179136 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20243096 | See source | Category B | XD06AXF045F002020180651 | NHSA |
| Hua Dong Pharmaceuticals (Xian) Bo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20249267 | See source | Category B | XD06AXF045F002030102469 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20264674 | See source | Category B | XD06AXF045F002030105356 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20150043 | See source | Category B | XD06AXF045F002030179136 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20243096 | See source | Category B | XD06AXF045F002030180651 | NHSA |
| Hua Dong Pharmaceuticals (Xian) Bo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20249267 | See source | Category B | XD06AXF045F002040102469 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20269140 | See source | Category B | XD06AXF045F002040180651 | NHSA |
| Hua Dong Pharmaceuticals (Xian) Bo Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20249267 | See source | Category B | XD06AXF045F002040202469 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20150043 | See source | Category B | XD06AXF045F002050179136 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20150044 | See source | Category B | 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.
Current under-review applications
Loaded records: 15 filings and 15 distinct first applicants.
Generic 14 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602426 | Generic | 2026/09/29 | Not stated by source | CDE |
| Haerbin Kui Hua Pharma Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. | CYHS2503853 | Generic | 2025/11/03 | Not stated by source | CDE |
| Shandong Nuo Ming Kang Drug Research Institute Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized | CYHS2503809 | Generic | 2025/10/28 | Not stated by source | CDE |
| Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized | CYHS2602563 | Generic | 2026/10/19 | Not stated by source | CDE |
| Henan Da Xin Pharma Co., Ltd. romanized | CYHS2602156 | Generic | 2026/08/28 | Not stated by source | CDE |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHB2601643 | Supplement | 2026/08/27 | Not stated by source | CDE |
| Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | CYHS2601936 | Generic | 2026/08/07 | Not stated by source | CDE |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | CYHS2601022 | Generic | 2026/04/30 | Not stated by source | CDE |
| Hubei Wu Shi Pharma Co., Ltd. romanized | CYHS2600642 | Generic | 2026/03/11 | Not stated by source | CDE |
| Shanxi Ze Chen Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600470 | Generic | 2026/02/13 | Not stated by source | CDE |
| Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized | CYHS2600141 | Generic | 2026/01/10 | Not stated by source | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2504362 | Generic | 2025/12/23 | Not stated by source | CDE |
| Zhejiang He Li Xin Jian Pharma Co., Ltd. romanized; Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized | CYHS2503600 | Generic | 2025/10/09 | Not stated by source | CDE |
| Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized | CYHS2503319 | Generic | 2025/09/09 | Not stated by source | CDE |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | CYHS2503100 | Generic | 2025/08/23 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 8 filings and 8 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602426 | Generic | 2026/09/29 | Not stated by source | CDE |
| Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized | CYHS2602563 | Generic | 2026/10/19 | Not stated by source | CDE |
| Henan Da Xin Pharma Co., Ltd. romanized | CYHS2602156 | Generic | 2026/08/28 | Not stated by source | CDE |
| Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | CYHS2601936 | Generic | 2026/08/07 | Not stated by source | CDE |
| Zhejiang Pu Li Pharma Co., Ltd. romanized | CYHS2601022 | Generic | 2026/04/30 | Not stated by source | CDE |
| Hubei Wu Shi Pharma Co., Ltd. romanized | CYHS2600642 | Generic | 2026/03/11 | Not stated by source | CDE |
| Shanxi Ze Chen Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600470 | Generic | 2026/02/13 | Not stated by source | CDE |
| Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized | CYHS2600141 | Generic | 2026/01/10 | Not stated by source | CDE |
API registrations
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 · No verified English name | Shandong Ge De Bio Technology Co., Ltd. romanized | Y20250000621 | I | Exact ingredient | 2025/09/29 | CDE |
| 夫西地酸钠 · No verified English name | Fujian Kang Hong Bio Technology Co., Ltd. romanized | Y20230000633 | A | Salt-normalized ingredient | 2026/10/20 | CDE |
| 夫西地酸 · No verified English name | Fujian Kang Hong Bio Technology Co., Ltd. romanized | Y20230000307 | A | Exact ingredient | 2026/10/20 | CDE |
| 夫西地酸钠 · No verified English name | Jiangsu Jiu Yang Biopharmaceutical Co., Ltd. romanized | Y20220001182 | A | Salt-normalized ingredient | 2024/07/23 | CDE |
| 夫西地酸钠 · No verified English name | ERCROS S.A. | Y20190009179 | A | Salt-normalized ingredient | 2023/03/24 | CDE |
| 夫西地酸钠 · No verified English name | ERCROS S.A. | Y20190009178 | A | Salt-normalized ingredient | 2023/03/24 | CDE |
| 夫西地酸钠 · No verified English name | Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized | Y20190007204 | A | Salt-normalized ingredient | 2023/05/25 | CDE |
| 夫西地酸钠 · No verified English name | Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20190005952 | A | Salt-normalized ingredient | 2025/10/30 | CDE |
| 夫西地酸钠 · No verified English name | Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized | Y20190004045 | A | Salt-normalized ingredient | 2025/06/14 | CDE |
| 夫西地酸钠 · No verified English name | LEO Pharma A/S | Y20170001447 | A | Salt-normalized ingredient | 2024/11/19 | CDE |
| 夫西地酸 · No verified English name | LEO Pharma A/S | Y20170001446 | A | Exact ingredient | 2024/11/12 | CDE |
| 夫西地酸 · No verified English name | Jiangsu Jiu Yang Biopharmaceutical Co., Ltd. romanized | 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.
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.
-
2026/11/07No longer listed under review
Wuhan Nuo An Pharma Co., Ltd. romanized; Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized
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 ↗ -
2026/11/05Supplement delivery
Wuhan Nuo An Pharma Co., Ltd. romanized
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 ↗ -
2026/10/29No longer listed under review
BRIGHT FUTURE PHARMACEUTICAL CO. LIMITED; BRIGHT FUTURE PHARMACEUTICALS FACTORY
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 ↗ -
2026/10/23No longer listed under review
Hangzhou Minsheng Pharmaceutical Co., Ltd
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 ↗ -
2026/10/23No longer listed under review
Hangzhou Minsheng Pharmaceutical Co., Ltd
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 ↗ -
2026/10/19Accepted
Wuhan Shi Xiao Bo Bio Technology Co., Ltd. romanized
CYHS2602563
Fact date: 2026/10/19 · Site observation date: 2026/10/22
View source ↗ -
2026/10/14Accepted
Wuhan Nuo An Pharma Co., Ltd. romanized; Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized
CYHB2601887
Fact date: 2026/10/14 · Site observation date: 2026/10/21
View source ↗ -
2026/09/29Accepted
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
CYHS2602426
Fact date: 2026/09/29 · Site observation date: 2026/10/21
View source ↗ -
2026/08/28Accepted
Henan Da Xin Pharma Co., Ltd. romanized
CYHS2602156
Fact date: 2026/08/28 · Site observation date: 2026/10/22
View source ↗ -
2026/08/27Accepted
Chongqing Huapont Pharmaceutical Co., Ltd.
CYHB2601643
Fact date: 2026/08/27 · 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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