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盐酸精氨酸注射液
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 3 applicationsNo 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 holders1View records ↓
Under-review filings6View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers9View records ↓
API companies with A status18View records ↓
Chemical-drug catalogue
Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 1 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 |
|---|---|---|---|---|---|---|
| 四川邈济生物医药科技有限公司 | 广东大翔制药有限公司 | 国药准字H20263031 | 2026/01/05 | 200ml:20g | 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: 9 distinct approval numbers and 9 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京赛升药业股份有限公司 | 国药准字H11020360 | 20ml:5g | Category A (甲) | XB05XBJ128B002010100112 | NHSA |
| 上海信谊金朱药业有限公司 | 国药准字H31021692 | 20ml:5g | Category A (甲) | XB05XBJ128B002010100801 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H12020999 | 20ml:5g | Category A (甲) | XB05XBJ128B002010100874 | NHSA |
| 重庆药友制药有限责任公司 | 国药准字H50020901 | 20ml:5g | Category A (甲) | XB05XBJ128B002010101066 | NHSA |
| 江苏康缘药业股份有限公司 | 国药准字H20046093 | 20ml:5g | Category A (甲) | XB05XBJ128B002010101463 | NHSA |
| 武汉久安药业有限公司 | 国药准字H42020916 | 20ml:5g | Category A (甲) | XB05XBJ128B002010101949 | NHSA |
| 武汉福星生物药业有限公司 | 国药准字H42023001 | 20ml:5g | Category A (甲) | XB05XBJ128B002010101962 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H22023248 | 20ml:5g | Category A (甲) | XB05XBJ128B002010103421 | NHSA |
| 四川邈济生物医药科技有限公司 | 国药准字H20263031 | 200ml:20g | Category A (甲) | XB05XBJ128B002010184422 | NHSA |
| 北京赛升药业股份有限公司 | 国药准字H11020360 | 20ml:5g | Category A (甲) | XB05XBJ128B002010200112 | NHSA |
| 上海信谊金朱药业有限公司 | 国药准字H31021692 | 20ml:5g | Category A (甲) | XB05XBJ128B002010200801 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H12020999 | 20ml:5g | Category A (甲) | XB05XBJ128B002010200874 | NHSA |
| 武汉久安药业有限公司 | 国药准字H42020916 | 20ml:5g | Category A (甲) | XB05XBJ128B002010201949 | NHSA |
| 武汉福星生物药业有限公司 | 国药准字H42023001 | 20ml:5g | Category A (甲) | XB05XBJ128B002010201962 | NHSA |
| 上海信谊金朱药业有限公司 | 国药准字H31021692 | 20ml:5g | Category A (甲) | XB05XBJ128B002020100801 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H22023248 | 20ml:5g | Category A (甲) | XB05XBJ128B002020103421 | 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: 6 filings and 6 distinct first applicants.
Generic 6
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏长江药业有限公司 | CYHS2602227 | Generic | 2026/09/07 | Not stated by source | CDE |
| 浙江医药股份有限公司新昌制药厂 | CYHS2602409 | Generic | 2026/09/24 | Not stated by source | CDE |
| 天圣制药集团股份有限公司 | CYHS2602012 | Generic | 2026/08/14 | Not stated by source | CDE |
| 四川奇裕医药科技有限公司;四川美大康佳乐药业有限公司 | CYHS2601144 | Generic | 2026/05/14 | Not stated by source | CDE |
| 海南广升誉制药有限公司;海南爱科制药有限公司 | CYHS2600130 | Generic | 2026/01/10 | Not stated by source | CDE |
| 北京柏雅联合药物研究所有限公司;山东华鲁制药有限公司 | CYHS2504175 | Generic | 2025/12/05 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 5 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏长江药业有限公司 | CYHS2602227 | Generic | 2026/09/07 | Not stated by source | CDE |
| 浙江医药股份有限公司新昌制药厂 | CYHS2602409 | Generic | 2026/09/24 | Not stated by source | CDE |
| 天圣制药集团股份有限公司 | CYHS2602012 | Generic | 2026/08/14 | Not stated by source | CDE |
| 四川奇裕医药科技有限公司;四川美大康佳乐药业有限公司 | CYHS2601144 | Generic | 2026/05/14 | Not stated by source | CDE |
| 海南广升誉制药有限公司;海南爱科制药有限公司 | CYHS2600130 | Generic | 2026/01/10 | Not stated by source | CDE |
API registrations
Non-component matches: 18 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 |
|---|---|---|---|---|---|---|
| 精氨酸 | 津药药业股份有限公司 | Y20190009655 | A | Salt-normalized ingredient | 2025/08/16 | CDE |
| 盐酸精氨酸 | 津药药业股份有限公司 | Y20190009648 | A | Exact ingredient | 2025/08/16 | CDE |
| 精氨酸 | 汕头市佳禾生物科技有限公司 | Y20190009552 | A | Salt-normalized ingredient | 2026/03/17 | CDE |
| 精氨酸 | 上海味之素氨基酸有限公司 | Y20190009448 | A | Salt-normalized ingredient | 2024/10/23 | CDE |
| 盐酸精氨酸 | 上海味之素氨基酸有限公司 | Y20190009447 | A | Exact ingredient | 2024/10/23 | CDE |
| 盐酸精氨酸 | 峨眉山市龙腾生物科技有限公司 | Y20190009375 | A | Exact ingredient | 2026/06/26 | CDE |
| 盐酸精氨酸 | 无锡晶海氨基酸股份有限公司 | Y20190008702 | A | Exact ingredient | 2026/05/20 | CDE |
| 精氨酸 | 无锡晶海氨基酸股份有限公司 | Y20190008699 | A | Salt-normalized ingredient | 2026/05/20 | CDE |
| 盐酸精氨酸 | 上海普利美诺氨基酸有限公司 | Y20190008436 | A | Exact ingredient | 2025/09/29 | CDE |
| 精氨酸 | 上海普利美诺氨基酸有限公司 | Y20190008357 | A | Salt-normalized ingredient | 2025/09/29 | CDE |
| 精氨酸 | 浙江白云山昂利康制药有限公司 | Y20190006773 | A | Salt-normalized ingredient | 2024/05/16 | CDE |
| 精氨酸 | 哈药集团三精明水药业有限公司 | Y20190005814 | A | Salt-normalized ingredient | 2025/09/19 | CDE |
| 盐酸精氨酸 | 北京赛而生物药业有限公司 | Y20190005654 | A | Exact ingredient | — | CDE |
| 精氨酸 | 湖北省潜江市四维氨基酸有限公司 | Y20190005280 | A | Salt-normalized ingredient | — | CDE |
| 精氨酸 | 精晶药业股份有限公司 | Y20190005213 | A | Salt-normalized ingredient | 2025/07/04 | CDE |
| 盐酸精氨酸 | 湖北鑫源生物工程有限公司 | Y20190005010 | A | Exact ingredient | — | CDE |
| 精氨酸 | 湖北鑫源生物工程有限公司 | Y20190005007 | A | Salt-normalized ingredient | — | CDE |
| 盐酸精氨酸 | 江西新赣江药业股份有限公司 | Y20190004611 | A | Exact ingredient | 2026/07/15 | CDE |
| 盐酸精氨酸 | 南宁赢创美诗药业有限公司 | Y20190003934 | A | Exact ingredient | 2025/01/07 | CDE |
| 盐酸精氨酸 | 武汉远大弘元股份有限公司 | Y20190003276 | A | Exact ingredient | 2026/03/05 | CDE |
| 盐酸精氨酸 | 湖北省潜江市四维氨基酸有限公司 | Y20190003094 | A | Exact ingredient | — | CDE |
| 精氨酸 | 湖北新生源生物工程有限公司 | Y20190001626 | A | Salt-normalized ingredient | 2024/11/12 | CDE |
| 盐酸精氨酸 | 峨眉山市龙腾生物科技有限公司 | Y20180000804 | I | Exact ingredient | 2019/07/05 | CDE |
| 精氨酸 | 汕头市佳禾生物科技有限公司 | Y20180001301 | I | Salt-normalized ingredient | 2019/05/28 | CDE |
| 盐酸精氨酸 | 天津天药药业股份有限公司 | Y20180000251 | I | Exact ingredient | 2018/09/29 | CDE |
| 精氨酸 | 天津天药药业股份有限公司 | Y20180000250 | I | Salt-normalized ingredient | 2018/09/19 | CDE |
| 精氨酸 | 山东睿鹰制药集团有限公司 | Y20170001496 | A | Salt-normalized ingredient | 2026/08/26 | CDE |
| 精氨酸 | 广东环西生物科技股份有限公司 | Y20170001051 | A | Salt-normalized ingredient | 2022/09/30 | CDE |
| 精氨酸 | 重庆圣华曦药业股份有限公司 | Y20170000873 | I | Salt-normalized 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.
-
2026/11/05No longer listed under review
石家庄四药有限公司
CYHS2502154
Fact date: 2026/11/05 · Site observation date: 2026/11/05
Accepted: 2025/06/17
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/09/24Accepted
-
2026/09/07Accepted
-
2026/08/14Accepted
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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