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As of 13 November 2026, for Potassium Aspartate Injection, 3 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 14 holders.
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.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
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 |
|---|---|---|---|---|---|---|
| Yang Pu Jing Tai Pharma Co., Ltd. romanized | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20269218 | 2026/08/28 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H20265548 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Xin Mei Tai Ke Pharmaceuticals Technology Co., Ltd. romanized | Hebei Tian Cheng Pharma Co., Ltd. romanized | 国药准字H20265487 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized | Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized | 国药准字H20265549 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Qidu Pharmaceutical Co., Ltd. | Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20264931 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20264617 | 2026/06/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | 国药准字H20133001 | 2026/03/30 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | 国药准字H20110032 | 2026/03/30 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized | Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20263483 | 2026/02/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Brilliant Pharmaceutical Co., Ltd. | Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20254312 | 2025/05/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20254272 | 2025/05/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20150024 | 2025/04/21 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20163416 | 2025/04/21 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Shandong Hua Lu Pharmaceutical Co., Ltd. romanized | Shandong Hua Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20249698 | 2024/12/06 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized | Shanghai Pu Jin Lin Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H20244775 | 2024/09/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized | Shanghai Pu Jin Lin Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H20244774 | 2024/09/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yang Pu Jing Tai Pharma Co., Ltd. romanized | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20243591 | 2024/04/24 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Suzhou Te Rui Pharma Co., Ltd. romanized | Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized | 国药准字H20183435 | 2024/01/24 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Guangzhou He He Pharmaceuticals Co., Ltd. romanized | Guangdong Sunho Pharmaceutical Co., Ltd. | 国药准字H20254913 | 2025/07/22 | See source | Generic approved under the new chemical-drug registration classification | 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 |
|---|---|---|---|---|---|
| Suzhou Te Rui Pharma Co., Ltd. romanized | 国药准字H20183435 | See source | Not stated by source | XB05XAM073B002010101504 | NHSA |
| Jilin Si Zhang Pharmaceutical Co., Ltd. romanized | 国药准字H20244837 | See source | Not stated by source | XB05XAM073B002010103282 | NHSA |
| Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20150024 | See source | Not stated by source | XB05XAM073B002010103889 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20264931 | See source | Not stated by source | XB05XAM073B002010104145 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20254272 | See source | Not stated by source | XB05XAM073B002010105597 | NHSA |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20254312 | See source | Not stated by source | XB05XAM073B002010105791 | NHSA |
| Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized | 国药准字H20244774 | See source | Not stated by source | XB05XAM073B002010107677 | NHSA |
| Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | 国药准字H20110032 | 10ml:1.712g | Not stated by source | XB05XAM073B002010109545 | NHSA |
| Tong Liao Shi Hua Bang Pharma Co., Ltd. romanized | 国药准字H20193165 | See source | Not stated by source | XB05XAM073B002010181421 | NHSA |
| Shandong Hua Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20249698 | See source | Not stated by source | XB05XAM073B002010183083 | NHSA |
| Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20264617 | See source | Not stated by source | XB05XAM073B002010183686 | NHSA |
| Yang Pu Jing Tai Pharma Co., Ltd. romanized | 国药准字H20243591 | See source | Not stated by source | XB05XAM073B002010183885 | NHSA |
| Guangzhou He He Pharmaceuticals Co., Ltd. romanized | 国药准字H20254913 | See source | Not stated by source | XB05XAM073B002010185013 | NHSA |
| Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized | 国药准字H20263483 | See source | Not stated by source | XB05XAM073B002010185516 | NHSA |
| Suzhou Te Rui Pharma Co., Ltd. romanized | 国药准字H20183435 | See source | Not stated by source | XB05XAM073B002010201504 | NHSA |
| Jilin Si Zhang Pharmaceutical Co., Ltd. romanized | 国药准字H20244837 | See source | Not stated by source | XB05XAM073B002010203282 | NHSA |
| Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20150024 | See source | Not stated by source | XB05XAM073B002010203889 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20264931 | See source | Not stated by source | XB05XAM073B002010204145 | NHSA |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20254312 | See source | Not stated by source | XB05XAM073B002010205791 | NHSA |
| Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized | 国药准字H20244774 | See source | Not stated by source | XB05XAM073B002010207677 | NHSA |
| Tong Liao Shi Hua Bang Pharma Co., Ltd. romanized | 国药准字H20193165 | See source | Not stated by source | XB05XAM073B002010281421 | NHSA |
| Shandong Hua Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20249698 | See source | Not stated by source | XB05XAM073B002010283083 | NHSA |
| Yang Pu Jing Tai Pharma Co., Ltd. romanized | 国药准字H20243591 | See source | Not stated by source | XB05XAM073B002010283885 | NHSA |
| Guangzhou He He Pharmaceuticals Co., Ltd. romanized | 国药准字H20254913 | See source | Not stated by source | XB05XAM073B002010285013 | NHSA |
| Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20163416 | See source | Not stated by source | XB05XAM073B002020103889 | NHSA |
| Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized | 国药准字H20244775 | See source | Not stated by source | XB05XAM073B002020107677 | NHSA |
| Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | 国药准字H20133001 | See source | Not stated by source | XB05XAM073B002020109545 | NHSA |
| Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20163416 | See source | Not stated by source | XB05XAM073B002020203889 | NHSA |
| Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized | 国药准字H20244775 | See source | Not stated by source | XB05XAM073B002020207677 | NHSA |
| Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | 国药准字H20133001 | See source | Not stated by source | XB05XAM073B002020209545 | NHSA |
| Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized | 国药准字H20244775 | See source | Not stated by source | XB05XAM073B002020307677 | NHSA |
| Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | 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 |
|---|---|---|---|---|---|
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | CYHS2602398 | Generic | 2026/09/23 | Not stated by source | CDE |
| Zhejiang Hai Han Pharma Co., Ltd. romanized | CYHS2600583 | Generic | 2026/02/28 | Not stated by source | CDE |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | CYHS2501430 | Generic | 2025/04/15 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized | CYHS2602398 | Generic | 2026/09/23 | Not stated by source | CDE |
| Zhejiang Hai Han Pharma Co., Ltd. romanized | CYHS2600583 | Generic | 2026/02/28 | Not stated by source | CDE |
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 · No verified English name | Suzhou Li Xin Pharmaceutical Co., Ltd. romanized | Y20250000631 | A | Salt-normalized ingredient | 2026/08/13 | CDE |
| 门冬氨酸 · No verified English name | Wuhan Yuan Da Hong Yuan Co., Ltd. romanized | Y20240001002 | A | Salt-normalized ingredient | 2026/06/02 | CDE |
| 门冬氨酸镁 · No verified English name | Hunan Sai Long Pharma Co., Ltd. romanized | Y20240000685 | A | Salt-normalized ingredient | 2025/11/26 | CDE |
| 门冬氨酸钾 · No verified English name | Hunan Sai Long Pharma Co., Ltd. romanized | Y20240000684 | A | Exact ingredient | 2025/11/26 | CDE |
| 门冬氨酸钾 · No verified English name | Jing Jing Pharma Co., Ltd. romanized | Y20230000945 | A | Exact ingredient | 2025/06/24 | CDE |
| 门冬氨酸镁 · No verified English name | Suzhou Li Xin Pharmaceutical Co., Ltd. romanized | Y20230000726 | I | Salt-normalized ingredient | 2025/05/20 | CDE |
| 门冬氨酸镁 · No verified English name | Jing Jing Pharma Co., Ltd. romanized | Y20230000944 | A | Salt-normalized ingredient | 2025/06/24 | CDE |
| 门冬氨酸钾 · No verified English name | Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized | Y20220000322 | A | Exact ingredient | 2025/02/06 | CDE |
| 门冬氨酸 · No verified English name | Jin Yao Pharma Co., Ltd. romanized | Y20190009656 | A | Salt-normalized ingredient | 2025/08/16 | CDE |
| 门冬氨酸 · No verified English name | Yuan Da Ba Feng (Hubei) Pharmaceuticals Co., Ltd. romanized | Y20190009528 | A | Salt-normalized ingredient | 2025/09/24 | CDE |
| 门冬氨酸钾 · No verified English name | Kyowa Hakko Bio Co., Ltd. | Y20190009166 | A | Exact ingredient | — | CDE |
| 门冬氨酸钾 · No verified English name | Tong Liao Shi Hua Bang Pharma Co., Ltd. romanized | Y20190008831 | A | Exact ingredient | 2024/07/04 | CDE |
| 门冬氨酸 · No verified English name | Nanning Ying Chuang Mei Shi Pharma Co., Ltd. romanized | Y20190008596 | A | Salt-normalized ingredient | 2025/01/07 | CDE |
| 门冬氨酸 · No verified English name | Shanghai Pu Li Mei Nuo An Ji Suan Co., Ltd. romanized | Y20190008353 | A | Salt-normalized ingredient | 2025/09/29 | CDE |
| 门冬氨酸钾 · No verified English name | Liaoning Yao Lian Pharmaceutical Co., Ltd. romanized | Y20190006845 | A | Exact ingredient | 2023/03/24 | CDE |
| 门冬氨酸镁 · No verified English name | Shenyang Guang Da Pharmaceutical Co., Ltd. romanized | Y20190006816 | A | Salt-normalized ingredient | 2024/01/13 | CDE |
| 门冬氨酸 · No verified English name | Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190005412 | A | Salt-normalized ingredient | — | CDE |
| 门冬氨酸镁 · No verified English name | Shanxi Pu De Pharma Co., Ltd. romanized | Y20190004638 | A | Salt-normalized ingredient | 2025/08/14 | CDE |
| 门冬氨酸钾 · No verified English name | Shanxi Pu De Pharma Co., Ltd. romanized | Y20190004570 | A | Exact ingredient | 2025/08/14 | CDE |
| 门冬氨酸镁 · No verified English name | Tianjin Jia Lin Ke Yi Co., Ltd. romanized | Y20190001880 | A | Salt-normalized ingredient | 2025/01/08 | CDE |
| 门冬氨酸钾 · No verified English name | Tianjin Jia Lin Ke Yi Co., Ltd. romanized | Y20190001660 | A | Exact ingredient | 2025/01/08 | CDE |
| 门冬氨酸钙 · No verified English name | Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized | Y20190001633 | A | Salt-normalized ingredient | 2024/11/19 | CDE |
| 门冬氨酸钾 · No verified English name | Shenyang Guang Da Pharmaceutical Co., Ltd. romanized | Y20190001433 | A | Exact ingredient | 2024/01/13 | CDE |
| 门冬氨酸 · No verified English name | Ajinomoto Co., Inc. | Y20190000473 | I | Salt-normalized ingredient | 2019/07/31 | CDE |
| 门冬氨酸 · No verified English name | Tianjin Tian Yao Pharma Co., Ltd. romanized | Y20180000244 | I | Salt-normalized ingredient | 2018/09/12 | CDE |
| 门冬氨酸 · No verified English name | Wei Zhi Su Zhu Shi Hui She romanized | Y20170002129 | I | Salt-normalized ingredient | — | CDE |
| 门冬氨酸钾 · No verified English name | Suzhou Li Xin Pharmaceutical Co., Ltd. romanized | Y20170001251 | A | Exact ingredient | 2023/05/24 | CDE |
| 门冬氨酸镁 · No verified English name | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | Y20170000912 | A | Salt-normalized ingredient | 2024/06/18 | CDE |
| 门冬氨酸钾 · No verified English name | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/09/23Accepted
Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized
CYHS2602398
Fact date: 2026/09/23 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
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: 2026/11/13 06:41
- 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: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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