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硫酸沙丁胺醇口服溶液
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationNo longer listed under review: 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 filings5View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers4View records ↓
API companies with A status15View 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: 4 distinct approval numbers and 4 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 海南万玮制药有限公司 | 国药准字H20264475 | 100ml:40mg(按C₁₃H₂₁NO₃计) | Not stated by source | XR03CCS048X001010182249 | NHSA |
| 海鸿恒隆(海南)生物科技有限公司 | 国药准字H20234376 | 100ml:40mg(按C₁₃H₂₁NO₃ 计) | Not stated by source | XR03CCS048X001010182834 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253364 | 5ml:2mg(按C₁₃H₂₁NO₃ 计) | Not stated by source | XR03CCS048X001010183595 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20254838 | 150ml:60mg(按C₁₃H₂₁NO₃ 计) | Not stated by source | XR03CCS048X001010184221 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253364 | 5ml:2mg(按C₁₃H₂₁NO₃ 计) | Not stated by source | XR03CCS048X001010283595 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253364 | 5ml:2mg(按C₁₃H₂₁NO₃ 计) | Not stated by source | XR03CCS048X001010383595 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253364 | 5ml:2mg(按C₁₃H₂₁NO₃ 计) | Not stated by source | XR03CCS048X001010483595 | 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: 5 filings and 5 distinct first applicants.
Generic 5
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海纳制药有限公司 | CYHS2600551 | Generic | 2026/02/26 | Not stated by source | CDE |
| 北京民康百草医药科技有限公司;湖南九典制药股份有限公司 | CYHS2601282 | Generic | 2026/06/04 | Not stated by source | CDE |
| 济南景笙科技有限公司;湖北唯森制药有限公司 | CYHS2600674 | Generic | 2026/03/19 | Not stated by source | CDE |
| 大玮（安徽）药业有限公司;华益药业科技（安徽）有限公司 | CYHS2503513 | Generic | 2025/09/25 | Not stated by source | CDE |
| 华益药业科技（安徽）有限公司 | CYHS2502351 | Generic | 2025/07/03 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海纳制药有限公司 | CYHS2600551 | Generic | 2026/02/26 | Not stated by source | CDE |
| 北京民康百草医药科技有限公司;湖南九典制药股份有限公司 | CYHS2601282 | Generic | 2026/06/04 | Not stated by source | CDE |
| 济南景笙科技有限公司;湖北唯森制药有限公司 | CYHS2600674 | Generic | 2026/03/19 | Not stated by source | CDE |
API registrations
Non-component matches: 15 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 |
|---|---|---|---|---|---|---|
| 硫酸沙丁胺醇 | OREX PHARMA PRIVATE LIMITED | Y20250000572 | I | Exact ingredient | 2025/07/14 | CDE |
| 沙丁胺醇 | 武汉武药制药有限公司 | Y20250000140 | A | Salt-normalized ingredient | 2026/08/31 | CDE |
| 硫酸沙丁胺醇 | CAMBREX PROFARMACO MILANO S.R.L. | Y20240000898 | A | Exact ingredient | 2026/09/22 | CDE |
| 硫酸沙丁胺醇 | 山东锐顺药业有限公司 | Y20240000418 | A | Exact ingredient | 2026/01/12 | CDE |
| 硫酸沙丁胺醇 | 新乡海滨药业有限公司 | Y20230000856 | I | Exact ingredient | 2024/10/17 | CDE |
| 硫酸沙丁胺醇 | 湖南华纳大药厂手性药物有限公司 | Y20230000262 | A | Exact ingredient | 2024/11/19 | CDE |
| 硫酸沙丁胺醇 | 浙江赛默制药有限公司 | Y20220000645 | A | Exact ingredient | 2025/07/09 | CDE |
| 硫酸沙丁胺醇 | 河北广祥制药有限公司 | Y20220000115 | A | Exact ingredient | 2026/08/25 | CDE |
| 硫酸沙丁胺醇 | 成都华宇制药有限公司 | Y20210001083 | A | Exact ingredient | 2024/05/08 | CDE |
| 硫酸沙丁胺醇 | Cambrex profarmaco Milano s.r.l. | Y20200001219 | I | Exact ingredient | 2024/04/03 | CDE |
| 硫酸沙丁胺醇 | 上海医药集团（本溪）北方药业有限公司 | Y20200001352 | A | Exact ingredient | 2024/01/17 | CDE |
| 硫酸沙丁胺醇 | Sicor Societa’ Italiana Corticosteroidi S.r.l. | Y20200000876 | A | Exact ingredient | 2025/07/04 | CDE |
| 硫酸沙丁胺醇 | 河北安健成益医药科技有限公司 | Y20200000448 | A | Exact ingredient | 2026/06/23 | CDE |
| 硫酸沙丁胺醇 | 常州亚邦制药有限公司 | Y20190009685 | A | Exact ingredient | — | CDE |
| 沙丁胺醇 | 常州亚邦制药有限公司 | Y20190004963 | A | Salt-normalized ingredient | 2025/07/18 | CDE |
| 硫酸沙丁胺醇 | 云鹏医药集团有限公司 | Y20190003223 | A | Exact ingredient | 2025/07/18 | CDE |
| 硫酸沙丁胺醇 | 苏州弘森药业股份有限公司 | Y20190003210 | A | Exact ingredient | 2025/06/06 | CDE |
| 沙丁胺醇 | 苏州弘森药业股份有限公司 | Y20190003201 | A | Salt-normalized ingredient | 2025/05/31 | CDE |
| 硫酸沙丁胺醇 | Neuland Laboratories Limited. | Y20190000025 | A | Exact ingredient | 2025/12/14 | CDE |
| 硫酸沙丁胺醇 | 四川仁安药业有限责任公司 | Y20180001258 | A | Exact ingredient | 2026/02/05 | CDE |
| 硫酸沙丁胺醇 | 常州亚邦制药有限公司 | Y20170002169 | A | Exact ingredient | 2025/05/31 | CDE |
| 硫酸沙丁胺醇 | 山东锐顺药业有限公司 | Y20170000574 | A | Exact ingredient | 2024/09/07 | 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
江苏润恒制药有限公司
CYHS2404663 · 国药准字H20266486
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 17 ↗ -
2026/10/24No longer listed under review
石家庄康力药业有限公司
CYHS2501700
Fact date: 2026/10/24 · Site observation date: 2026/10/24
Accepted: 2025/05/10
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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