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硫酸特布他林口服溶液
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 filings4View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers7View 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: 7 distinct approval numbers and 5 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 成都利尔药业有限公司 | 国药准字H20249477 | 100ml:50mg | Not stated by source | XR03CCT022X001010102044 | NHSA |
| 北京民康百草医药科技有限公司 | 国药准字H20263627 | 100ml:50mg | Not stated by source | XR03CCT022X001010183644 | NHSA |
| 合肥国药诺和药业有限公司 | 国药准字H20254731 | 100ml:50mg | Not stated by source | XR03CCT022X001010183719 | NHSA |
| 杭州上禾健康科技有限公司 | 国药准字H20233619 | 60ml:30mg | Not stated by source | XR03CCT022X001010184213 | NHSA |
| 成都医路融曜药物科技有限公司 | 国药准字H20265665 | 60ml:30mg | Not stated by source | XR03CCT022X001010186481 | NHSA |
| 成都利尔药业有限公司 | 国药准字H20249476 | 30ml:15mg | Not stated by source | XR03CCT022X001020102044 | NHSA |
| 合肥国药诺和药业有限公司 | 国药准字H20254732 | 50ml:25mg | Not stated by source | XR03CCT022X001020183719 | 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: 4 filings and 4 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 苏州弘森药业股份有限公司;扬州市三药制药有限公司 | CYHS2600696 | Generic | 2026/03/23 | Not stated by source | CDE |
| 上海美优制药有限公司 | CYHS2601951 | Generic | 2026/08/10 | Not stated by source | CDE |
| 安徽杰玺医药有限公司 | CYHS2601006 | Generic | 2026/04/30 | Not stated by source | CDE |
| 武汉益博元医药科技有限公司;赤峰源生药业有限公司 | CYHS2503992 | Generic | 2025/11/18 | 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 |
|---|---|---|---|---|---|
| 苏州弘森药业股份有限公司;扬州市三药制药有限公司 | CYHS2600696 | Generic | 2026/03/23 | Not stated by source | CDE |
| 上海美优制药有限公司 | CYHS2601951 | Generic | 2026/08/10 | Not stated by source | CDE |
| 安徽杰玺医药有限公司 | CYHS2601006 | Generic | 2026/04/30 | Not stated by source | CDE |
API registrations
Non-component matches: 23 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 |
|---|---|---|---|---|---|---|
| 硫酸特布他林 | 湖南华纳大药厂手性药物有限公司 | Y20250000175 | A | Exact ingredient | 2026/10/12 | CDE |
| 硫酸特布他林 | 云南龙海天然植物药业有限公司 | Y20240001422 | A | Exact ingredient | 2026/08/11 | CDE |
| 硫酸特布他林 | 石家庄海力药业有限公司 | Y20230001323 | A | Exact ingredient | 2026/04/09 | CDE |
| 硫酸特布他林 | 吉林汇康制药有限公司 | Y20230000877 | A | Exact ingredient | 2025/02/26 | CDE |
| 硫酸特布他林 | 四川子仁制药有限公司 | Y20220001102 | I | Exact ingredient | 2023/08/16 | CDE |
| 硫酸特布他林 | 浙江金华康恩贝生物制药有限公司 | Y20230000539 | A | Exact ingredient | 2025/11/04 | CDE |
| 硫酸特布他林 | 福安药业集团宁波天衡制药有限公司 | Y20220001029 | A | Exact ingredient | 2025/05/15 | CDE |
| 硫酸特布他林 | 浙江赛默制药有限公司 | Y20220000547 | A | Exact ingredient | 2025/06/07 | CDE |
| 硫酸特布他林 | 济宁神州医药有限公司 | Y20220000379 | A | Exact ingredient | 2026/04/08 | CDE |
| 硫酸特布他林 | 山东海佑福瑞达制药有限公司 | Y20210001281 | A | Exact ingredient | 2026/03/20 | CDE |
| 硫酸特布他林 | 成都奥邦药业有限公司 | Y20210000786 | A | Exact ingredient | 2023/12/13 | CDE |
| 硫酸特布他林 | 植恩生物技术股份有限公司 | Y20210000916 | A | Exact ingredient | 2026/03/21 | CDE |
| 硫酸特布他林 | 四川科伦药业股份有限公司 | Y20210000543 | A | Exact ingredient | 2024/03/07 | CDE |
| 硫酸特布他林 | 安徽恒星制药有限公司 | Y20210000510 | A | Exact ingredient | 2023/03/24 | CDE |
| 硫酸特布他林 | 四川仁安药业有限责任公司 | Y20200001068 | A | Exact ingredient | 2026/09/21 | CDE |
| 硫酸特布他林 | SHIMOGA CHEMICALS | Y20200000317 | A | Exact ingredient | 2024/06/20 | CDE |
| 硫酸特布他林 | MELODY HEALTHCARE PVT. LTD. | Y20200000166 | A | Exact ingredient | 2026/11/08 | CDE |
| 硫酸特布他林 | 河北国龙制药有限公司 | Y20190021527 | A | Exact ingredient | 2025/12/12 | CDE |
| 硫酸特布他林 | 成都华宇制药有限公司 | Y20190009442 | A | Exact ingredient | — | CDE |
| 硫酸特布他林 | AstraZeneca AB | Y20190009177 | A | Exact ingredient | 2024/09/03 | CDE |
| 硫酸特布他林 | 上海旭东海普药业有限公司 | Y20190008483 | A | Exact ingredient | 2025/03/15 | CDE |
| 硫酸特布他林 | 河北安健成益医药科技有限公司 | Y20190000620 | A | Exact ingredient | 2024/05/28 | CDE |
| 硫酸特布他林 | 苏州弘森药业股份有限公司 | Y20170002314 | A | Exact ingredient | 2025/09/16 | CDE |
| 硫酸特布他林 | 成都华宇制药有限公司 | Y20170002163 | A | Exact ingredient | 2022/10/24 | CDE |
| 硫酸特布他林 | 四川美大康华康药业有限公司 | Y20170001172 | A | Exact ingredient | 2025/05/15 | CDE |
| 硫酸特布他林 | SHIMOGA CHEMICALS | Y20170000560 | I | Exact 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.
-
2026/10/20Marketing application approved
山东致泰医药技术有限公司
CYHS2500699 · 国药准字H20266288
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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 33 ↗
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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