Monthly
US$200
Billed every month
Polymyxin B sulfate for Injection(注射用硫酸多黏菌素B)
Companies, stages and changes, with each record available on this page.
Last 90 days: No longer listed under review: 4 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 holders14View records ↓
Under-review filings6View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers17View records ↓
API companies with A status10View records ↓
Chemical-drug catalogue
Loaded records: 14 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 14 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 |
|---|---|---|---|---|---|---|
| 福建省福抗药业股份有限公司 | 海南全星制药有限公司 | 国药准字H20266022 | 2026/09/15 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 海南双成药业股份有限公司 | 海南双成药业股份有限公司 | 国药准字H20265679 | 2026/08/18 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 合肥华威药业有限公司 | 山东豪瑞恩制药有限公司 | 国药准字H20265327 | 2026/07/21 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 广州艾奇西新药研究有限公司 | 广东星昊药业有限公司 | 国药准字H20264928 | 2026/06/23 | 50 万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 山东序列生物科技有限公司 | 博瑞制药（苏州）有限公司 | 国药准字H20264579 | 2026/06/03 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 要素（上海）医疗科技有限公司 | 山东豪瑞恩制药有限公司 | 国药准字H20264436 | 2026/05/19 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 海南合瑞制药股份有限公司 | 海南合瑞制药股份有限公司 | 国药准字H20264123 | 2026/04/21 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 齐鲁制药（海南）有限公司 | 齐鲁制药（海南）有限公司 | 国药准字H20263777 | 2026/03/31 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 湖南埃威格林医药科技有限公司 | 哈尔滨三联药业股份有限公司 | 国药准字H20263682 | 2026/03/25 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 健康元药业集团股份有限公司 | 健康元海滨药业有限公司 | 国药准字H20263370 | 2026/02/10 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 合肥亿帆生物制药有限公司 | 合肥亿帆生物制药有限公司 | 国药准字H20263089 | 2026/01/14 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 四川上善六经医药科技有限公司 | 成都天台山制药股份有限公司 | 国药准字H20255210 | 2025/08/26 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 江苏利泰尔药业有限公司 | 江苏利泰尔药业有限公司 | 国药准字H20255208 | 2025/08/26 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 四川汇宇海玥医药科技有限公司 | 四川汇宇制药股份有限公司 | 国药准字H20254318 | 2025/05/27 | 50万单位 | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | 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: 17 distinct approval numbers and 17 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 福建省福抗药业股份有限公司 | 国药准字H20266022 | 50万单位 | Category B (乙) | XJ01XBD198B001010104791 | NHSA |
| 海南合瑞制药股份有限公司 | 国药准字H20264123 | 50万单位 | Category B (乙) | XJ01XBD198B001010105815 | NHSA |
| 齐鲁制药(海南)有限公司 | 国药准字H20263777 | 50万单位 | Category B (乙) | XJ01XBD198B001010105847 | NHSA |
| Xellia Pharmaceuticals ApS | 国药准字HJ20250039 | 50万单位 | Category B (乙) | XJ01XBD198B001010179515 | NHSA |
| 江苏利泰尔药业有限公司 | 国药准字H20255208 | 50万单位 | Category B (乙) | XJ01XBD198B001010182291 | NHSA |
| 合肥亿帆生物制药有限公司 | 国药准字H20263089 | 50万单位 | Category B (乙) | XJ01XBD198B001010182719 | NHSA |
| 健康元药业集团股份有限公司 | 国药准字H20263370 | 50万单位 | Category B (乙) | XJ01XBD198B001010183037 | NHSA |
| 要素(上海)医疗科技有限公司 | 国药准字H20264436 | 50万单位 | Category B (乙) | XJ01XBD198B001010184081 | NHSA |
| 湖南埃威格林医药科技有限公司 | 国药准字H20263682 | 50万单位 | Category B (乙) | XJ01XBD198B001010184441 | NHSA |
| 四川汇宇海玥医药科技有限公司 | 国药准字H20254318 | 50万单位 | Category B (乙) | XJ01XBD198B001010184532 | NHSA |
| 成都雅途生物技术有限公司 | 国药准字H20264537 | 50万单位 | Category B (乙) | XJ01XBD198B001010184540 | NHSA |
| 广州艾奇西新药研究有限公司 | 国药准字H20264928 | 50 万单位 | Category B (乙) | XJ01XBD198B001010184971 | NHSA |
| 广东万泰元科创药业有限公司 | 国药准字H20265753 | 50万单位 | Category B (乙) | XJ01XBD198B001010185190 | NHSA |
| 山东序列生物科技有限公司 | 国药准字H20264579 | 50万单位 | Category B (乙) | XJ01XBD198B001010185565 | NHSA |
| 海南倍特药业有限公司 | 国药准字H20254404 | 50万单位 | Category B (乙) | XJ01XBD198B001010205791 | NHSA |
| 海南合瑞制药股份有限公司 | 国药准字H20264123 | 50万单位 | Category B (乙) | XJ01XBD198B001010205815 | NHSA |
| Xellia Pharmaceuticals ApS | 国药准字HJ20250039 | 50万单位 | Category B (乙) | XJ01XBD198B001010279515 | NHSA |
| 健康元药业集团股份有限公司 | 国药准字H20263370 | 50万单位 | Category B (乙) | XJ01XBD198B001010283037 | NHSA |
| 要素(上海)医疗科技有限公司 | 国药准字H20264436 | 50万单位 | Category B (乙) | XJ01XBD198B001010284081 | NHSA |
| 山东序列生物科技有限公司 | 国药准字H20264579 | 50万单位 | Category B (乙) | XJ01XBD198B001010285565 | NHSA |
| 上海上药第一生化药业有限公司 | 国药准字H31022631 | 50万单位 | Category B (乙) | XJ01XBD198B014010100651 | NHSA |
| 海南双成药业股份有限公司 | 国药准字H20265679 | 50万单位 | Category B (乙) | XJ01XBD198B001010105814 | 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: 6 filings and 6 distinct first applicants.
Generic 5 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 湖州亚瑟制药有限公司 | CYHS2601064 | Generic | 2026/05/09 | Not stated by source | CDE |
| 河北圣雪大成制药有限责任公司;华北制药股份有限公司 | CYHS2600966 | Generic | 2026/04/25 | Not stated by source | CDE |
| 烟台鲁银药业有限公司 | CYHS2502410 | Generic | 2025/07/08 | Not stated by source | CDE |
| 上海上药第一生化药业有限公司 | CYHB2550332 | Supplement | 2025/09/28 | Not stated by source | CDE |
| 国药集团国瑞药业有限公司 | CYHS2502963 | Generic | 2025/08/14 | Not stated by source | CDE |
| 河北锐健医药科技有限公司;成都通德药业有限公司 | CYHS2502821 | Generic | 2025/08/05 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 10 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 硫酸多黏菌素B | 赣州瑞智生物医药有限公司 | Y20250001047 | I | Exact ingredient | 2025/10/15 | CDE |
| 硫酸多黏菌素B | 河北圣雪大成制药有限责任公司 | Y20240000964 | A | Exact ingredient | 2026/04/14 | CDE |
| 硫酸多黏菌素B | 山东鲁西药业有限公司 | Y20240000914 | A | Exact ingredient | 2026/09/11 | CDE |
| 硫酸多黏菌素B | 福建省福抗药业股份有限公司 | Y20240000823 | A | Exact ingredient | 2026/07/01 | CDE |
| 硫酸多黏菌素B | 四川诺宜生药业有限公司 | Y20240000179 | A | Exact ingredient | 2025/12/31 | CDE |
| 硫酸多黏菌素B | 杭州中美华东制药江东有限公司 | Y20230000987 | A | Exact ingredient | 2026/05/20 | CDE |
| 硫酸多黏菌素B | 华北制药华胜有限公司 | Y20230000780 | A | Exact ingredient | 2025/06/10 | CDE |
| 硫酸多黏菌素B | 丽珠集团福州福兴医药有限公司 | Y20230000739 | A | Exact ingredient | 2026/07/28 | CDE |
| 硫酸多黏菌素B | 四川仁安药业有限责任公司 | Y20230000683 | A | Exact ingredient | 2025/03/21 | CDE |
| 硫酸多黏菌素B | 杭州中美华东制药江东有限公司 | Y20220000257 | A | Exact ingredient | 2024/08/05 | CDE |
| 硫酸多黏菌素B | Xellia Pharmaceuticals ApS | Y20190009041 | A | Exact ingredient | 2024/11/29 | CDE |
| 硫酸多黏菌素B | Xellia Pharmaceuticals ApS | Y20190009030 | A | Exact ingredient | 2024/11/29 | CDE |
| 硫酸多黏菌素B（供局部用） | Xellia Pharmaceuticals ApS | Y20190000206 | I | Exact ingredient | 2019/04/12 | CDE |
| 硫酸多黏菌素B（供注射用） | Xellia Pharmaceuticals ApS | Y20190000204 | I | Exact ingredient | 2019/04/12 | CDE |
| 硫酸多黏菌素B | 杭州中美华东制药有限公司 | Y20170000899 | A | Exact ingredient | 2023/03/24 | 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.
-
2026/11/10No longer listed under review
福安药业集团烟台只楚药业有限公司
CYHS2501237
Fact date: 2026/11/10 · Site observation date: 2026/11/10
Accepted: 2025/04/01
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/11/04No longer listed under review
江苏迪赛诺制药有限公司
CYHS2500724
Fact date: 2026/11/04 · Site observation date: 2026/11/04
Accepted: 2025/02/13
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/24No longer listed under review
安徽省先锋制药有限公司
CYHS2500852
Fact date: 2026/10/24 · Site observation date: 2026/10/24
Accepted: 2025/02/26
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/24No longer listed under review
桂林南药股份有限公司;苏州二叶制药有限公司
CYHS2500394
Fact date: 2026/10/24 · Site observation date: 2026/10/24
Accepted: 2025/01/22
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗
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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