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磷霉素氨丁三醇颗粒
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 applicationNotification delivery: 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 holders3View records ↓
Under-review filings5View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers3View records ↓
API companies with A status9View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 2 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 |
|---|---|---|---|---|---|---|
| 海南赛立克药业有限公司 | 海南赛立克药业有限公司 | 国药准字H20265415 | 2026/07/28 | 3g（按C3H7O4P计） | 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 |
| Zambon Switzerland Ltd | Zambon Switzerland Ltd. | H20140127 | 2000/02/19 | 3g(300万单位 ) | Imported originator drug (进口原研药品) | CDE |
| 湖北午时医药研究院有限公司 | 湖北午时药业股份有限公司 | 国药准字H20266190 | 2026/10/13 | 3g（按C3H7O4P计） | 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: 3 distinct approval numbers and 3 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 海南赛立克药业有限公司 | 国药准字H20265415 | 3g(按C₃H₇O₄P计) | Category B (乙) | XJ01XXL097N001010105805 | NHSA |
| Zambon Switzerland Ltd. | 国药准字HJ20140127 | 3g(300万单位)(按C3H7O4P计) | Category B (乙) | XJ01XXL097N001010178963 | NHSA |
| 海南赛立克药业有限公司 | 国药准字H20265415 | 3g(按C₃H₇O₄P计) | Category B (乙) | XJ01XXL097N001010205805 | NHSA |
| 湖北午时医药研究院有限公司 | 国药准字H20266190 | 3g(按C₃H₇O₄P计) | Category B (乙) | XJ01XXL097N001010184568 | 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 4 · Import 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海纳制药有限公司 | CYHS2602259 | Generic | 2026/09/10 | Not stated by source | CDE |
| 安徽新世纪药业有限公司 | CYHS2601402 | Generic | 2026/06/12 | Not stated by source | CDE |
| 成都倍特药业股份有限公司 | CYHS2503685 | Generic | 2025/10/15 | Not stated by source | CDE |
| 辽宁海一制药有限公司 | CYHS2501855 | Generic | 2025/05/23 | Not stated by source | CDE |
| LABIANA Pharmaceuticals S.L.U.;Labiana Pharmaceuticals S.L.U.;Nanjing Dorra Pharmaceutical Technology Co. Ltd. | JYHS2500016 | Import | 2025/04/03 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 9 companies with A status and 5 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 |
|---|---|---|---|---|---|---|
| 磷霉素钠 | 瑞阳制药股份有限公司 | Y20250001344 | I | Salt-normalized ingredient | 2026/06/04 | CDE |
| 磷霉素钙 | 安徽鼎旺医药有限公司 | Y20260000427 | I | Salt-normalized ingredient | 2026/06/01 | CDE |
| 磷霉素钠 | 精晶药业股份有限公司 | Y20260000146 | I | Salt-normalized ingredient | 2026/03/16 | CDE |
| 磷霉素钠 | 福安药业集团重庆博圣制药有限公司 | Y20250001120 | I | Salt-normalized ingredient | 2025/11/25 | CDE |
| 磷霉素钠 | 浙江白云山昂利康制药有限公司 | Y20250000589 | I | Salt-normalized ingredient | 2025/06/27 | CDE |
| 磷霉素钙 | 赤峰艾克制药科技股份有限公司 | Y20240000818 | A | Salt-normalized ingredient | 2026/01/30 | CDE |
| 磷霉素钠 | ERCROS, S.A. | Y20230000979 | A | Salt-normalized ingredient | 2024/12/25 | CDE |
| 磷霉素氨丁三醇 | 湖南华纳大药厂手性药物有限公司 | Y20190008939 | A | Exact ingredient | 2024/01/30 | CDE |
| 磷霉素钙 | 山西东进制药有限公司 | Y20190005637 | A | Salt-normalized ingredient | — | CDE |
| 磷霉素钠 | 山西东进制药有限公司 | Y20190005636 | A | Salt-normalized ingredient | — | CDE |
| 磷霉素氨丁三醇 | 桂林华信制药有限公司 | Y20190005284 | A | Exact ingredient | 2024/09/21 | CDE |
| 磷霉素钠 | 上海上药新亚药业有限公司 | Y20190005149 | A | Salt-normalized ingredient | — | CDE |
| 磷霉素钙 | 上海上药新亚药业有限公司 | Y20190005146 | A | Salt-normalized ingredient | — | CDE |
| 磷霉素钠 | 哈药集团三精明水药业有限公司 | Y20190004363 | A | Salt-normalized ingredient | 2025/07/12 | CDE |
| 磷霉素氨丁三醇 | 东北制药集团股份有限公司 | Y20190003126 | A | Exact ingredient | 2024/04/24 | CDE |
| 磷霉素钙 | 东北制药集团股份有限公司 | Y20190003103 | A | Salt-normalized ingredient | 2024/04/24 | CDE |
| 磷霉素钠 | 东北制药集团股份有限公司 | Y20190003101 | A | Salt-normalized ingredient | 2024/04/24 | CDE |
| 磷霉素钠 | 山西仟源医药集团股份有限公司 | Y20190002881 | A | Salt-normalized ingredient | — | CDE |
| 磷霉素钙 | 山西仟源医药集团股份有限公司 | Y20190002878 | A | Salt-normalized ingredient | — | CDE |
| 磷霉素氨丁三醇 | 山西仟源医药集团股份有限公司 | Y20190002877 | A | 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.
-
2026/11/04Notification delivery
四川新斯顿制药股份有限公司
CYHS2503910
Fact date: 2026/11/04 (Publication date) · Publication date: 2026/11/04 · Site observation date: 2026/11/04
Notification delivered; the specific outcome remains to be checked.
View source · Table row 9 ↗ -
2026/09/10Accepted
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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