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Gatifloxacin Eye Drops(加替沙星滴眼液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 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.
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 filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers12View records ↓
API companies with A status18View 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: 12 distinct approval numbers and 12 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 药铭成德(广州)医药科技有限公司 | 国药准字H20120030 | 5ml:15mg | Category B (乙) | XS01AEJ022G010010100389 | NHSA |
| 中国大冢制药有限公司 | 国药准字H20110119 | 0.3% | Category B (乙) | XS01AEJ022G010010100967 | NHSA |
| 江苏吉贝尔药业股份有限公司 | 国药准字H20090236 | 0.3% | Category B (乙) | XS01AEJ022G010010101452 | NHSA |
| 江苏云阳集团药业有限公司 | 国药准字H20060049 | 5ml:15mg | Category B (乙) | XS01AEJ022G010010101519 | NHSA |
| 宜昌诺安制药有限公司 | 国药准字H20183158 | 0.3%(5ml:15mg) | Category B (乙) | XS01AEJ022G010010101955 | NHSA |
| 郑州卓峰制药有限公司 | 国药准字H20080653 | 0.3% | Category B (乙) | XS01AEJ022G010010103273 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20051825 | 0.3%(g/ml) | Category B (乙) | XS01AEJ022G010010104335 | NHSA |
| 合肥利民制药有限公司 | 国药准字H20263197 | 0.3%(5ml:15mg) | Category B (乙) | XS01AEJ022G010010104423 | NHSA |
| 楚雄老拨云堂药业有限公司 | 国药准字H20060479 | 8ml:24mg(低密度聚乙烯塑料瓶装,10ml/支×1支/盒;低 | Category B (乙) | XS01AEJ022G010010105593 | NHSA |
| 宁夏康亚药业股份有限公司 | 国药准字H20203201 | 0.3%(5ml:15mg) | Category B (乙) | XS01AEJ022G010010105911 | NHSA |
| 广州仁恒医药科技股份有限公司 | 国药准字H20254611 | 0.3%(5ml:15mg) | Category B (乙) | XS01AEJ022G010010184019 | NHSA |
| 合肥源丰顺医药科技有限公司 | 国药准字H20256085 | 0.3%(5ml:15mg) | Category B (乙) | XS01AEJ022G010010184751 | NHSA |
| 宜昌诺安制药有限公司 | 国药准字H20183158 | 0.3%(5ml:15mg) | Category B (乙) | XS01AEJ022G010010201955 | NHSA |
| 合肥利民制药有限公司 | 国药准字H20263197 | 0.3%(5ml:15mg) | Category B (乙) | XS01AEJ022G010010204423 | NHSA |
| 中国大冢制药有限公司 | 国药准字H20110119 | 0.3% | Category B (乙) | XS01AEJ022G010020100967 | NHSA |
| 江苏吉贝尔药业股份有限公司 | 国药准字H20090236 | 0.3% | Category B (乙) | XS01AEJ022G010020101452 | NHSA |
| 郑州卓峰制药有限公司 | 国药准字H20080653 | 0.3% | Category B (乙) | XS01AEJ022G010020103273 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20051825 | 0.3%(g/ml) | Category B (乙) | XS01AEJ022G010020104335 | NHSA |
| 楚雄老拨云堂药业有限公司 | 国药准字H20060479 | 8ml:24mg(低密度聚乙烯塑料瓶装,10ml/支×1支/盒;低 | Category B (乙) | XS01AEJ022G010020105593 | NHSA |
| 中国大冢制药有限公司 | 国药准字H20110119 | 0.3% | Category B (乙) | XS01AEJ022G010030100967 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20051825 | 0.3%(g/ml) | Category B (乙) | XS01AEJ022G010030104335 | NHSA |
| 楚雄老拨云堂药业有限公司 | 国药准字H20060479 | 8ml:24mg(低密度聚乙烯塑料瓶装,10ml/支×1支/盒;低 | Category B (乙) | XS01AEJ022G010030105593 | NHSA |
| 中国大冢制药有限公司 | 国药准字H20110119 | 0.3% | Category B (乙) | XS01AEJ022G010040100967 | 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: 3 filings and 2 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 润尔眼科药物（广州）有限公司 | CYHS2601932 | Generic | 2026/08/07 | Not stated by source | CDE |
| 珠海前列药业有限公司;湖南华纳大药厂股份有限公司 | CYHS2601710 | Generic | 2026/07/17 | Not stated by source | CDE |
| 珠海前列药业有限公司;湖南华纳大药厂股份有限公司 | CYHS2601709 | Generic | 2026/07/17 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 润尔眼科药物（广州）有限公司 | CYHS2601932 | Generic | 2026/08/07 | Not stated by source | CDE |
| 珠海前列药业有限公司;湖南华纳大药厂股份有限公司 | CYHS2601710 | Generic | 2026/07/17 | Not stated by source | CDE |
| 珠海前列药业有限公司;湖南华纳大药厂股份有限公司 | CYHS2601709 | Generic | 2026/07/17 | Not stated by source | CDE |
API registrations
Non-component matches: 18 companies with A status and 2 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 |
|---|---|---|---|---|---|---|
| 加替沙星 | 大连永达苏利药业有限公司 | Y20250001032 | I | Exact ingredient | 2025/10/13 | CDE |
| 加替沙星 | 江苏吉贝尔药业股份有限公司 | Y20240000024 | A | Exact ingredient | 2025/10/22 | CDE |
| 加替沙星 | 合肥立方制药股份有限公司 | Y20230000214 | A | Exact ingredient | 2024/12/20 | CDE |
| 加替沙星 | 宁夏康亚药业股份有限公司 | Y20220000678 | I | Exact ingredient | 2023/12/19 | CDE |
| 加替沙星 | 湖北华丹医药科技股份有限公司 | Y20190008909 | A | Exact ingredient | 2023/03/24 | CDE |
| 加替沙星 | 四川仁安药业有限责任公司 | Y20190007219 | A | Exact ingredient | 2023/05/31 | CDE |
| 盐酸加替沙星 | 江苏永达药业有限公司 | Y20190007165 | A | Salt-normalized ingredient | — | CDE |
| 加替沙星 | 悦康药业集团安徽天然制药有限公司 | Y20190006482 | A | Exact ingredient | 2026/03/19 | CDE |
| 加替沙星 | 江苏永达药业有限公司 | Y20190006468 | A | Exact ingredient | — | CDE |
| 加替沙星 | 修正药业集团柳河制药有限公司 | Y20190006024 | A | Exact ingredient | 2025/03/29 | CDE |
| 甲磺酸加替沙星 | 绍兴京新药业有限公司 | Y20190005424 | A | Salt-normalized ingredient | 2024/06/12 | CDE |
| 甲磺酸加替沙星 | 江苏奥赛康药业有限公司 | Y20190004764 | A | Salt-normalized ingredient | — | CDE |
| 加替沙星 | 江苏恒瑞医药股份有限公司 | Y20190004678 | A | Exact ingredient | — | CDE |
| 加替沙星 | 苏中药业集团股份有限公司 | Y20190004063 | A | Exact ingredient | 2025/10/16 | CDE |
| 加替沙星 | 湖北亨迪药业股份有限公司 | Y20190003106 | A | Exact ingredient | 2025/06/06 | CDE |
| 加替沙星 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20190002698 | A | Exact ingredient | — | CDE |
| 盐酸加替沙星 | 浙江医药股份有限公司新昌制药厂 | Y20190002634 | A | Salt-normalized ingredient | 2025/02/13 | CDE |
| 加替沙星 | 四川百利药业有限责任公司 | Y20190002633 | A | Exact ingredient | 2025/10/30 | CDE |
| 加替沙星 | 浙江尖峰药业有限公司 | Y20190002485 | A | Exact ingredient | — | CDE |
| 甲磺酸加替沙星 | 河南康泰药业有限公司 | Y20190001775 | A | Salt-normalized ingredient | 2024/09/11 | CDE |
| 乳酸加替沙星 | 浙江浙邦制药有限公司 | Y20190001764 | A | Salt-normalized ingredient | — | 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
合肥诺瑞特制药有限公司
CYHS2501102 · 国药准字H20266445
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 40 ↗
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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