Monthly
US$200
Billed every month
Potassium Aspartate Injection(门冬氨酸钾注射液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 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 holders14View records ↓
Under-review filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers17View records ↓
API companies with A status18View records ↓
Chemical-drug catalogue
Loaded records: 14 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 11 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 |
|---|---|---|---|---|---|---|
| 洋浦京泰药业有限公司 | 内蒙古白医制药股份有限公司 | 国药准字H20269218 | 2026/08/28 | 20ml﹕门冬氨酸钾3.424g（按C4H6KNO4计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 海南慧通生物医药科技有限公司 | 山东北大高科华泰制药有限公司 | 国药准字H20265548 | 2026/08/04 | 20ml：门冬氨酸钾3.424g（按C4H6KNO4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 |
| 北京新美泰克医药科技有限公司 | 河北天成药业股份有限公司 | 国药准字H20265487 | 2026/08/04 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4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 |
| 海南慧通生物医药科技有限公司 | 山东北大高科华泰制药有限公司 | 国药准字H20265549 | 2026/08/04 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4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 |
| 山东齐都药业有限公司 | 山东齐都药业有限公司 | 国药准字H20264931 | 2026/06/23 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4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 |
| 知和（山东）大药厂有限公司 | 知和（山东）大药厂有限公司 | 国药准字H20264617 | 2026/06/03 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4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 |
| 辽宁药联制药有限公司 | 辽宁药联制药有限公司 | 国药准字H20133001 | 2026/03/30 | 20ml：门冬氨酸钾3.424g（按C4H6KNO4计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 辽宁药联制药有限公司 | 辽宁药联制药有限公司 | 国药准字H20110032 | 2026/03/30 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 海韬新药研发（江苏）有限公司 | 知和（山东）大药厂有限公司 | 国药准字H20263483 | 2026/02/25 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4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 |
| 海南倍特药业有限公司 | 海南倍特药业有限公司 | 国药准字H20254312 | 2025/05/27 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4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 |
| 昆明南疆制药有限公司 | 湖南科伦制药有限公司 | 国药准字H20254272 | 2025/05/27 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4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 |
| 内蒙古白医制药股份有限公司 | 内蒙古白医制药股份有限公司 | 国药准字H20150024 | 2025/04/21 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 内蒙古白医制药股份有限公司 | 内蒙古白医制药股份有限公司 | 国药准字H20163416 | 2025/04/21 | 20ml：门冬氨酸钾3.424g（按C4H6KNO4计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 山东华鲁制药有限公司 | 山东华鲁制药有限公司 | 国药准字H20249698 | 2024/12/06 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4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 |
| 焦作市民康药业有限公司 | 上海浦津林州制药有限公司 | 国药准字H20244775 | 2024/09/03 | 20ml:门冬氨酸钾3.424g（按C4H6KNO4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 |
| 焦作市民康药业有限公司 | 上海浦津林州制药有限公司 | 国药准字H20244774 | 2024/09/03 | 10ml:门冬氨酸钾1.712g（按C4H6KNO4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 |
| 洋浦京泰药业有限公司 | 内蒙古白医制药股份有限公司 | 国药准字H20243591 | 2024/04/24 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4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 |
| 苏州特瑞药业股份有限公司 | 江苏吴中医药集团有限公司苏州制药厂 | 国药准字H20183435 | 2024/01/24 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4计） | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 广州合和医药有限公司 | 广东星昊药业有限公司 | 国药准字H20254913 | 2025/07/22 | 10ml：门冬氨酸钾1.712g（按C4H6KNO4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: 17 distinct approval numbers and 14 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 苏州特瑞药业股份有限公司 | 国药准字H20183435 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010101504 | NHSA |
| 吉林四长制药有限公司 | 国药准字H20244837 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010103282 | NHSA |
| 内蒙古白医制药股份有限公司 | 国药准字H20150024 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010103889 | NHSA |
| 山东齐都药业有限公司 | 国药准字H20264931 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010104145 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H20254272 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010105597 | NHSA |
| 海南倍特药业有限公司 | 国药准字H20254312 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010105791 | NHSA |
| 焦作市民康药业有限公司 | 国药准字H20244774 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010107677 | NHSA |
| 辽宁药联制药有限公司 | 国药准字H20110032 | 10ml:1.712g | Not stated by source | XB05XAM073B002010109545 | NHSA |
| 通辽市华邦药业有限公司 | 国药准字H20193165 | 10ml:门冬氨酸钾1.712g(K+:10mEq) | Not stated by source | XB05XAM073B002010181421 | NHSA |
| 山东华鲁制药有限公司 | 国药准字H20249698 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010183083 | NHSA |
| 知和(山东)大药厂有限公司 | 国药准字H20264617 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄ 计) | Not stated by source | XB05XAM073B002010183686 | NHSA |
| 洋浦京泰药业有限公司 | 国药准字H20243591 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010183885 | NHSA |
| 广州合和医药有限公司 | 国药准字H20254913 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010185013 | NHSA |
| 海韬新药研发(江苏)有限公司 | 国药准字H20263483 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010185516 | NHSA |
| 苏州特瑞药业股份有限公司 | 国药准字H20183435 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010201504 | NHSA |
| 吉林四长制药有限公司 | 国药准字H20244837 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010203282 | NHSA |
| 内蒙古白医制药股份有限公司 | 国药准字H20150024 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010203889 | NHSA |
| 山东齐都药业有限公司 | 国药准字H20264931 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010204145 | NHSA |
| 海南倍特药业有限公司 | 国药准字H20254312 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010205791 | NHSA |
| 焦作市民康药业有限公司 | 国药准字H20244774 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010207677 | NHSA |
| 通辽市华邦药业有限公司 | 国药准字H20193165 | 10ml:门冬氨酸钾1.712g(K+:10mEq) | Not stated by source | XB05XAM073B002010281421 | NHSA |
| 山东华鲁制药有限公司 | 国药准字H20249698 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010283083 | NHSA |
| 洋浦京泰药业有限公司 | 国药准字H20243591 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010283885 | NHSA |
| 广州合和医药有限公司 | 国药准字H20254913 | 10ml:门冬氨酸钾1.712g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002010285013 | NHSA |
| 内蒙古白医制药股份有限公司 | 国药准字H20163416 | 20ml:门冬氨酸钾3.424g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002020103889 | NHSA |
| 焦作市民康药业有限公司 | 国药准字H20244775 | 20ml:门冬氨酸钾3.424g(按C₄H₆KNO₄ 计 | Not stated by source | XB05XAM073B002020107677 | NHSA |
| 辽宁药联制药有限公司 | 国药准字H20133001 | 20ml:门冬氨酸钾3.424g | Not stated by source | XB05XAM073B002020109545 | NHSA |
| 内蒙古白医制药股份有限公司 | 国药准字H20163416 | 20ml:门冬氨酸钾3.424g(按C₄H₆KNO₄计) | Not stated by source | XB05XAM073B002020203889 | NHSA |
| 焦作市民康药业有限公司 | 国药准字H20244775 | 20ml:门冬氨酸钾3.424g(按C₄H₆KNO₄ 计 | Not stated by source | XB05XAM073B002020207677 | NHSA |
| 辽宁药联制药有限公司 | 国药准字H20133001 | 20ml:门冬氨酸钾3.424g | Not stated by source | XB05XAM073B002020209545 | NHSA |
| 焦作市民康药业有限公司 | 国药准字H20244775 | 20ml:门冬氨酸钾3.424g(按C₄H₆KNO₄ 计 | Not stated by source | XB05XAM073B002020307677 | NHSA |
| 辽宁药联制药有限公司 | 国药准字H20110032 | 10ml:1.712g | Not stated by source | XB05XAM073B002030109545 | 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 3 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 中国大冢制药有限公司 | CYHS2602398 | Generic | 2026/09/23 | Not stated by source | CDE |
| 浙江海瀚药业有限公司 | CYHS2600583 | Generic | 2026/02/28 | Not stated by source | CDE |
| 石家庄四药有限公司 | CYHS2501430 | Generic | 2025/04/15 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 18 companies with A status and 4 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 |
|---|---|---|---|---|---|---|
| 门冬氨酸镁 | 苏州立新制药有限公司 | Y20250000631 | A | Salt-normalized ingredient | 2026/08/13 | CDE |
| 门冬氨酸 | 武汉远大弘元股份有限公司 | Y20240001002 | A | Salt-normalized ingredient | 2026/06/02 | CDE |
| 门冬氨酸镁 | 湖南赛隆药业有限公司 | Y20240000685 | A | Salt-normalized ingredient | 2025/11/26 | CDE |
| 门冬氨酸钾 | 湖南赛隆药业有限公司 | Y20240000684 | A | Exact ingredient | 2025/11/26 | CDE |
| 门冬氨酸钾 | 精晶药业股份有限公司 | Y20230000945 | A | Exact ingredient | 2025/06/24 | CDE |
| 门冬氨酸镁 | 苏州立新制药有限公司 | Y20230000726 | I | Salt-normalized ingredient | 2025/05/20 | CDE |
| 门冬氨酸镁 | 精晶药业股份有限公司 | Y20230000944 | A | Salt-normalized ingredient | 2025/06/24 | CDE |
| 门冬氨酸钾 | 焦作市民康药业有限公司 | Y20220000322 | A | Exact ingredient | 2025/02/06 | CDE |
| 门冬氨酸 | 津药药业股份有限公司 | Y20190009656 | A | Salt-normalized ingredient | 2025/08/16 | CDE |
| 门冬氨酸 | 远大八峰（湖北）医药股份有限公司 | Y20190009528 | A | Salt-normalized ingredient | 2025/09/24 | CDE |
| 门冬氨酸钾 | Kyowa Hakko Bio Co., Ltd. | Y20190009166 | A | Exact ingredient | — | CDE |
| 门冬氨酸钾 | 通辽市华邦药业有限公司 | Y20190008831 | A | Exact ingredient | 2024/07/04 | CDE |
| 门冬氨酸 | 南宁赢创美诗药业有限公司 | Y20190008596 | A | Salt-normalized ingredient | 2025/01/07 | CDE |
| 门冬氨酸 | 上海普利美诺氨基酸有限公司 | Y20190008353 | A | Salt-normalized ingredient | 2025/09/29 | CDE |
| 门冬氨酸钾 | 辽宁药联制药有限公司 | Y20190006845 | A | Exact ingredient | 2023/03/24 | CDE |
| 门冬氨酸镁 | 沈阳光大制药有限公司 | Y20190006816 | A | Salt-normalized ingredient | 2024/01/13 | CDE |
| 门冬氨酸 | 华润双鹤药业股份有限公司 | Y20190005412 | A | Salt-normalized ingredient | — | CDE |
| 门冬氨酸镁 | 山西普德药业有限公司 | Y20190004638 | A | Salt-normalized ingredient | 2025/08/14 | CDE |
| 门冬氨酸钾 | 山西普德药业有限公司 | Y20190004570 | A | Exact ingredient | 2025/08/14 | CDE |
| 门冬氨酸镁 | 天津嘉林科医有限公司 | Y20190001880 | A | Salt-normalized ingredient | 2025/01/08 | CDE |
| 门冬氨酸钾 | 天津嘉林科医有限公司 | Y20190001660 | A | Exact ingredient | 2025/01/08 | CDE |
| 门冬氨酸钙 | 上海旭东海普药业有限公司 | Y20190001633 | A | Salt-normalized ingredient | 2024/11/19 | CDE |
| 门冬氨酸钾 | 沈阳光大制药有限公司 | Y20190001433 | A | Exact ingredient | 2024/01/13 | CDE |
| 门冬氨酸 | Ajinomoto Co., Inc. | Y20190000473 | I | Salt-normalized ingredient | 2019/07/31 | CDE |
| 门冬氨酸 | 天津天药药业股份有限公司 | Y20180000244 | I | Salt-normalized ingredient | 2018/09/12 | CDE |
| 门冬氨酸 | 味之素株式会社 | Y20170002129 | I | Salt-normalized ingredient | — | CDE |
| 门冬氨酸钾 | 苏州立新制药有限公司 | Y20170001251 | A | Exact ingredient | 2023/05/24 | CDE |
| 门冬氨酸镁 | 内蒙古白医制药股份有限公司 | Y20170000912 | A | Salt-normalized ingredient | 2024/06/18 | CDE |
| 门冬氨酸钾 | 内蒙古白医制药股份有限公司 | Y20170000911 | A | Exact ingredient | 2024/06/18 | 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.
-
2026/09/23Accepted
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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