Monthly
US$200
Billed every month
甲硝唑凝胶
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/10 07:27
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 filings13View records ↓
This year’s generic filers6View records ↓
NHSA approval numbers13View records ↓
API companies with A status23View 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: 13 distinct approval numbers and 12 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 天津市天骄制药有限公司 | 国药准字H19990245 | 0.75% | Category B (乙) | XG01AFJ070U001010100922 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H10980213 | 20g:0.15g | Category B (乙) | XG01AFJ070U001010101486 | NHSA |
| 德全药品(江苏)股份有限公司 | 国药准字H20255625 | 0.75%(20g:150mg) | Category B (乙) | XG01AFJ070U001010101751 | NHSA |
| 湖北康正药业有限公司 | 国药准字H20055522 | 10g:75mg | Category B (乙) | XG01AFJ070U001010101826 | NHSA |
| 远大医药(仙桃)制药有限公司 | 国药准字H20264876 | 0.75%(10g:75mg) | Category B (乙) | XG01AFJ070U001010101862 | NHSA |
| 山东方明药业集团股份有限公司 | 国药准字H20057598 | 20g:0.15g | Category B (乙) | XG01AFJ070U001010104083 | NHSA |
| 合肥启旸生物医药科技有限公司 | 国药准字H20255441 | 0.75%(10g:75mg) | Category B (乙) | XG01AFJ070U001010104394 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20264980 | 0.75%(30g:225mg) | Category B (乙) | XG01AFJ070U001010105356 | NHSA |
| 海南海神同洲制药有限公司 | 国药准字H20113203 | 0.75% | Category B (乙) | XG01AFJ070U001010105777 | NHSA |
| 山西振东安欣生物制药有限公司 | 国药准字H20255580 | 0.75%(30g:225mg) | Category B (乙) | XG01AFJ070U001010181098 | NHSA |
| 无锡朗润医药有限公司 | 国药准字H20254240 | 0.75%(45克:337.5毫克) | Category B (乙) | XG01AFJ070U001010184056 | NHSA |
| 浙江寰领医药科技有限公司 | 国药准字H20264072 | 0.75%(40g:300mg) | Category B (乙) | XG01AFJ070U001010184239 | NHSA |
| 合肥启旸生物医药科技有限公司 | 国药准字H20255441 | 0.75%(10g:75mg) | Category B (乙) | XG01AFJ070U001010204394 | NHSA |
| 海南海神同洲制药有限公司 | 国药准字H20113203 | 0.75% | Category B (乙) | XG01AFJ070U001010205777 | NHSA |
| 合肥启旸生物医药科技有限公司 | 国药准字H20255441 | 0.75%(10g:75mg) | Category B (乙) | XG01AFJ070U001010304394 | NHSA |
| 海南海神同洲制药有限公司 | 国药准字H20113203 | 0.75% | Category B (乙) | XG01AFJ070U001010305777 | NHSA |
| 合肥启旸生物医药科技有限公司 | 国药准字H20255441 | 0.75%(10g:75mg) | Category B (乙) | XG01AFJ070U001010404394 | NHSA |
| 海南海神同洲制药有限公司 | 国药准字H20113203 | 0.75% | Category B (乙) | XG01AFJ070U001010405777 | NHSA |
| 海南海神同洲制药有限公司 | 国药准字H20113203 | 0.75% | Category B (乙) | XG01AFJ070U001010505777 | NHSA |
| 天津市天骄制药有限公司 | 国药准字H19990245 | 0.75% | Category B (乙) | XG01AFJ070U001020100922 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H10980213 | 20g:0.15g | Category B (乙) | XG01AFJ070U001020101486 | NHSA |
| 湖北康正药业有限公司 | 国药准字H20055522 | 10g:75mg | Category B (乙) | XG01AFJ070U001020101826 | NHSA |
| 山东方明药业集团股份有限公司 | 国药准字H20057598 | 20g:0.15g | Category B (乙) | XG01AFJ070U001020104083 | NHSA |
| 海南海神同洲制药有限公司 | 国药准字H20113203 | 0.75% | Category B (乙) | XG01AFJ070U001020105777 | NHSA |
| 山东方明药业集团股份有限公司 | 国药准字H20057598 | 20g:0.15g | Category B (乙) | XG01AFJ070U001020204083 | NHSA |
| 天津市天骄制药有限公司 | 国药准字H19990244 | 10g:75mg | Category B (乙) | XG01AFJ070U001030100922 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H10980213 | 20g:0.15g | Category B (乙) | XG01AFJ070U001030101486 | NHSA |
| 湖北康正药业有限公司 | 国药准字H20055522 | 10g:75mg | Category B (乙) | XG01AFJ070U001030101826 | NHSA |
| 山东方明药业集团股份有限公司 | 国药准字H20057598 | 20g:0.15g | Category B (乙) | XG01AFJ070U001030104083 | NHSA |
| 海南海神同洲制药有限公司 | 国药准字H20113203 | 0.75% | Category B (乙) | XG01AFJ070U001030105777 | NHSA |
| 天津市天骄制药有限公司 | 国药准字H19990244 | 10g:75mg | Category B (乙) | XG01AFJ070U001040100922 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H10980213 | 20g:0.15g | Category B (乙) | XG01AFJ070U001040101486 | NHSA |
| 湖北康正药业有限公司 | 国药准字H20055522 | 10g:75mg | Category B (乙) | XG01AFJ070U001040101826 | NHSA |
| 山东方明药业集团股份有限公司 | 国药准字H20057598 | 20g:0.15g | Category B (乙) | XG01AFJ070U001040104083 | NHSA |
| 海南海神同洲制药有限公司 | 国药准字H20113203 | 0.75% | Category B (乙) | XG01AFJ070U001040105777 | NHSA |
| 天津市天骄制药有限公司 | 国药准字H19990244 | 10g:75mg | Category B (乙) | XG01AFJ070U001050100922 | NHSA |
| 湖北康正药业有限公司 | 国药准字H20055522 | 10g:75mg | Category B (乙) | XG01AFJ070U001050101826 | NHSA |
| 海南海神同洲制药有限公司 | 国药准字H20113203 | 0.75% | Category B (乙) | XG01AFJ070U001050105777 | NHSA |
| 湖北康正药业有限公司 | 国药准字H20055522 | 10g:75mg | Category B (乙) | XG01AFJ070U001050201826 | NHSA |
| 天津市天骄制药有限公司 | 国药准字H19990245 | 0.75% | Category B (乙) | XG01AFJ070U001060100922 | NHSA |
| 湖北康正药业有限公司 | 国药准字H20055522 | 10g:75mg | Category B (乙) | XG01AFJ070U001060101826 | NHSA |
| 海南海神同洲制药有限公司 | 国药准字H20113203 | 0.75% | Category B (乙) | XG01AFJ070U001060105777 | NHSA |
| 湖北康正药业有限公司 | 国药准字H20055522 | 10g:75mg | Category B (乙) | XG01AFJ070U001070101826 | 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: 13 filings and 10 distinct first applicants.
Supplement 2 · Generic 11
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 德全药品（江苏）股份有限公司 | CYHB2601471 | Supplement | 2026/07/31 | Not stated by source | CDE |
| 浙江昂利康制药股份有限公司;杭州民生药业股份有限公司 | CYHB2601379 | Supplement | 2026/07/21 | Not stated by source | CDE |
| 安徽杰玺医药有限公司 | CYHS2601640 | Generic | 2026/07/09 | Not stated by source | CDE |
| 湖北长江瑞益医药科技有限公司;远大医药（仙桃）制药有限公司 | CYHS2601501 | Generic | 2026/06/26 | Not stated by source | CDE |
| 河南大新药业有限公司 | CYHS2601225 | Generic | 2026/06/01 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2601224 | Generic | 2026/06/01 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2601223 | Generic | 2026/06/01 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2601222 | Generic | 2026/06/01 | Not stated by source | CDE |
| 山东辰欣佛都药业股份有限公司 | CYHS2601215 | Generic | 2026/06/01 | Not stated by source | CDE |
| 广州朗圣药业有限公司 | CYHS2601018 | Generic | 2026/04/30 | Not stated by source | CDE |
| 杭州呋欧医药科技有限公司;浙江赛默制药有限公司 | CYHS2502415 | Generic | 2025/07/08 | Not stated by source | CDE |
| 杭州呋欧医药科技有限公司;浙江赛默制药有限公司 | CYHS2502414 | Generic | 2025/07/08 | Not stated by source | CDE |
| 杭州和泽坤元药业有限公司;杭州民生药业股份有限公司 | CYHS2502172 | Generic | 2025/06/18 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 8 filings and 6 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 安徽杰玺医药有限公司 | CYHS2601640 | Generic | 2026/07/09 | Not stated by source | CDE |
| 湖北长江瑞益医药科技有限公司;远大医药（仙桃）制药有限公司 | CYHS2601501 | Generic | 2026/06/26 | Not stated by source | CDE |
| 河南大新药业有限公司 | CYHS2601225 | Generic | 2026/06/01 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2601224 | Generic | 2026/06/01 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2601223 | Generic | 2026/06/01 | Not stated by source | CDE |
| 遂成药业股份有限公司 | CYHS2601222 | Generic | 2026/06/01 | Not stated by source | CDE |
| 山东辰欣佛都药业股份有限公司 | CYHS2601215 | Generic | 2026/06/01 | Not stated by source | CDE |
| 广州朗圣药业有限公司 | CYHS2601018 | Generic | 2026/04/30 | Not stated by source | CDE |
API registrations
Non-component matches: 23 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 |
|---|---|---|---|---|---|---|
| 甲硝唑 | 济南明鑫制药股份有限公司 | Y20240000004 | A | Exact ingredient | 2025/08/01 | CDE |
| 甲硝唑 | 信合援生制药股份有限公司 | Y20220000637 | A | Exact ingredient | 2026/03/03 | CDE |
| 甲硝唑 | AARTI DRUGS LIMITED | Y20210000013 | A | Exact ingredient | 2023/04/07 | CDE |
| 甲硝唑 | 广西金兴制药有限责任公司 | Y20209990025 | A | Exact ingredient | 2024/10/09 | CDE |
| 甲硝唑 | 黄冈银河阿迪药业有限公司 | Y20190009773 | A | Exact ingredient | 2026/01/20 | CDE |
| 甲硝唑 | 湖北省宏源药业科技股份有限公司 | Y20190009755 | A | Exact ingredient | — | CDE |
| 甲硝唑 | 山西同济药业有限公司 | Y20190008615 | A | Exact ingredient | 2026/08/05 | CDE |
| 甲硝唑 | 武汉武药制药有限公司 | Y20190008552 | A | Exact ingredient | 2025/06/12 | CDE |
| 甲硝唑 | 青岛首和金海制药有限公司 | Y20190005405 | A | Exact ingredient | 2024/01/12 | CDE |
| 甲硝唑 | 江苏吉贝尔药业股份有限公司 | Y20190004966 | A | Exact ingredient | 2025/05/07 | CDE |
| 甲硝唑 | 桂林南药股份有限公司 | Y20190004293 | A | Exact ingredient | 2025/01/18 | CDE |
| 甲硝唑 | 东港市宏达制药有限公司 | Y20190004198 | A | Exact ingredient | 2025/04/15 | CDE |
| 甲硝唑 | 广东香雪药业有限公司 | Y20190003967 | A | Exact ingredient | — | CDE |
| 甲硝唑 | 锦州九泰药业有限责任公司 | Y20190003819 | A | Exact ingredient | 2025/05/13 | CDE |
| 甲硝唑 | 丹东医创药业有限责任公司 | Y20190003816 | A | Exact ingredient | 2025/06/07 | CDE |
| 甲硝唑 | 万邦德制药集团有限公司 | Y20190003607 | A | Exact ingredient | 2024/11/02 | CDE |
| 甲硝唑 | 苏州弘森药业股份有限公司 | Y20190003215 | A | Exact ingredient | 2025/06/06 | CDE |
| 甲硝唑 | 宜昌东阳光长江药业股份有限公司 | Y20190003169 | A | Exact ingredient | — | CDE |
| 甲硝唑 | 河北广祥制药有限公司 | Y20190002958 | A | Exact ingredient | 2024/07/23 | CDE |
| 甲硝唑 | 山西仟源医药集团股份有限公司 | Y20190002879 | A | Exact ingredient | — | CDE |
| 甲硝唑 | 黄冈赛康药业有限公司 | Y20190002607 | A | Exact ingredient | 2026/05/20 | CDE |
| 甲硝唑 | 恒诚制药集团淮南有限公司 | Y20190002432 | A | Exact ingredient | 2025/01/14 | CDE |
| 甲硝唑 | 广东华润顺峰药业有限公司 | Y20190001518 | A | Exact ingredient | 2024/08/15 | CDE |
| 甲硝唑 | 黄冈银河阿迪药业有限公司 | Y20170001867 | A | Exact ingredient | 2024/10/17 | CDE |
| 甲硝唑 | 湖北省宏源药业科技股份有限公司 | Y20170001945 | A | Exact ingredient | 2026/02/05 | 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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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