Monthly
US$200
Billed every month
Levocarnitine Oral Solution(左卡尼汀口服溶液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 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 filings9View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers37View records ↓
API companies with A status11View records ↓
Chemical-drug catalogue
Loaded records: 1 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 |
|---|---|---|---|---|---|---|
| ALFASIGMA S.p.A. | ALFASIGMA S.p.A. | H20171307 | 2013/06/26 | 10ml:1g | Imported originator drug (进口原研药品) | CDE |
| ALFASIGMA S.p.A. | ALFASIGMA S.p.A. | H20171308 | 2013/06/26 | 10ml:2g | Imported originator drug (进口原研药品) | 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: 37 distinct approval numbers and 32 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 广州一品红制药有限公司 | 国药准字H20255565 | 10ml:1g | Category B (乙) | XG04BXZ059X001010101012 | NHSA |
| 大连美罗中药厂有限公司 | 国药准字H20103448 | 10ml:1g | Category B (乙) | XG04BXZ059X001010101123 | NHSA |
| 东北制药集团沈阳第一制药有限公司 | 国药准字H19990372 | 10ml:1g | Category B (乙) | XG04BXZ059X001010101162 | NHSA |
| 东药集团沈阳施德药业有限公司 | 国药准字H20253799 | 10ml:1g | Category B (乙) | XG04BXZ059X001010101317 | NHSA |
| 常州兰陵制药有限公司 | 国药准字H20000522 | 10ml:1g | Category B (乙) | XG04BXZ059X001010101376 | NHSA |
| 石家庄四药有限公司 | 国药准字H20254530 | 10ml:1g | Category B (乙) | XG04BXZ059X001010102763 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H20254544 | 10ml:1g | Category B (乙) | XG04BXZ059X001010103421 | NHSA |
| 哈尔滨誉衡制药有限公司 | 国药准字H20255544 | 10ml:1g | Category B (乙) | XG04BXZ059X001010103687 | NHSA |
| 黑龙江中桂制药有限公司 | 国药准字H20264294 | 10ml:1g | Category B (乙) | XG04BXZ059X001010103804 | NHSA |
| 山东齐都药业有限公司 | 国药准字H20123100 | 10ml:1g | Category B (乙) | XG04BXZ059X001010104145 | NHSA |
| 山东益康药业股份有限公司 | 国药准字H20203109 | 10ml:1g | Category B (乙) | XG04BXZ059X001010104193 | NHSA |
| 西洲医药科技(浙江)有限公司 | 国药准字H20244005 | 10ml:1g | Category B (乙) | XG04BXZ059X001010104610 | NHSA |
| 浙江凯润药业股份有限公司 | 国药准字H20223622 | 10ml:1g | Category B (乙) | XG04BXZ059X001010104649 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20265285 | 10ml:1g | Category B (乙) | XG04BXZ059X001010104685 | NHSA |
| 岳阳新华达制药有限公司 | 国药准字H20263359 | 10ml:1g | Category B (乙) | XG04BXZ059X001010104918 | NHSA |
| 湖南明瑞制药股份有限公司 | 国药准字H20173337 | 10ml:1g | Category B (乙) | XG04BXZ059X001010105001 | NHSA |
| 北京康祯生物科技有限公司 | 国药准字H20249135 | 10ml:1g | Category B (乙) | XG04BXZ059X001010109198 | NHSA |
| 辽宁诺维诺制药股份有限公司 | 国药准字H20254713 | 10ml:1g | Category B (乙) | XG04BXZ059X001010110029 | NHSA |
| 江苏盈科生物制药有限公司 | 国药准字H20254950 | 10ml:1g | Category B (乙) | XG04BXZ059X001010110137 | NHSA |
| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | H20171061 | 10ml:1g | Category B (乙) | XG04BXZ059X001010178871 | NHSA |
| ALFASIGMA S.p.A. | H20171307 | 10ml:1g | Category B (乙) | XG04BXZ059X001010182194 | NHSA |
| 北京诚济制药股份有限公司 | 国药准字H20193098 | 10ml:1g | Category B (乙) | XG04BXZ059X001010182209 | NHSA |
| 成都倍特得诺药业有限公司 | 国药准字H20265020 | 10ml∶1g | Category B (乙) | XG04BXZ059X001010182338 | NHSA |
| 舒美奇成都生物科技有限公司 | 国药准字H20244178 | 10ml:1g | Category B (乙) | XG04BXZ059X001010183337 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20254529 | 10ml:1g | Category B (乙) | XG04BXZ059X001010183595 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20265500 | 10ml:1g | Category B (乙) | XG04BXZ059X001010183611 | NHSA |
| 四川嘉创景态生物医药科技有限公司 | 国药准字H20233597 | 10ml:1g | Category B (乙) | XG04BXZ059X001010183919 | NHSA |
| 古戈尔药业(海南)有限责任公司 | 国药准字H20249189 | 10ml:1g | Category B (乙) | XG04BXZ059X001010184286 | NHSA |
| 江苏百奥信康医药科技有限公司 | 国药准字H20249495 | 10ml:1g | Category B (乙) | XG04BXZ059X001010184329 | NHSA |
| 湖北欣泽霏药业有限公司 | 国药准字H20243026 | 10ml:1g | Category B (乙) | XG04BXZ059X001010184522 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20249009 | 10ml:1g | Category B (乙) | XG04BXZ059X001010185253 | NHSA |
| 江苏天平药业有限公司 | 国药准字H20264835 | 10ml∶1g | Category B (乙) | XG04BXZ059X001010186360 | NHSA |
| 大连美罗中药厂有限公司 | 国药准字H20103448 | 10ml:1g | Category B (乙) | XG04BXZ059X001010201123 | NHSA |
| 东北制药集团沈阳第一制药有限公司 | 国药准字H19990372 | 10ml:1g | Category B (乙) | XG04BXZ059X001010201162 | NHSA |
| 石家庄四药有限公司 | 国药准字H20254530 | 10ml:1g | Category B (乙) | XG04BXZ059X001010202763 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H20254544 | 10ml:1g | Category B (乙) | XG04BXZ059X001010203421 | NHSA |
| 哈尔滨誉衡制药有限公司 | 国药准字H20255544 | 10ml:1g | Category B (乙) | XG04BXZ059X001010203687 | NHSA |
| 山东齐都药业有限公司 | 国药准字H20123100 | 10ml:1g | Category B (乙) | XG04BXZ059X001010204145 | NHSA |
| 山东益康药业股份有限公司 | 国药准字H20203109 | 10ml:1g | Category B (乙) | XG04BXZ059X001010204193 | NHSA |
| 西洲医药科技(浙江)有限公司 | 国药准字H20244005 | 10ml:1g | Category B (乙) | XG04BXZ059X001010204610 | NHSA |
| 浙江凯润药业股份有限公司 | 国药准字H20223622 | 10ml:1g | Category B (乙) | XG04BXZ059X001010204649 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20265285 | 10ml:1g | Category B (乙) | XG04BXZ059X001010204685 | NHSA |
| 湖南明瑞制药股份有限公司 | 国药准字H20173337 | 10ml:1g | Category B (乙) | XG04BXZ059X001010205001 | NHSA |
| 北京康祯生物科技有限公司 | 国药准字H20249135 | 10ml:1g | Category B (乙) | XG04BXZ059X001010209198 | NHSA |
| 辽宁诺维诺制药股份有限公司 | 国药准字H20254713 | 10ml:1g | Category B (乙) | XG04BXZ059X001010210029 | NHSA |
| ALFASIGMA S.p.A. | H20171307 | 10ml:1g | Category B (乙) | XG04BXZ059X001010282194 | NHSA |
| 北京诚济制药股份有限公司 | 国药准字H20193098 | 10ml:1g | Category B (乙) | XG04BXZ059X001010282209 | NHSA |
| 成都倍特得诺药业有限公司 | 国药准字H20265020 | 10ml∶1g | Category B (乙) | XG04BXZ059X001010282338 | NHSA |
| 舒美奇成都生物科技有限公司 | 国药准字H20244178 | 10ml:1g | Category B (乙) | XG04BXZ059X001010283337 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20254529 | 10ml:1g | Category B (乙) | XG04BXZ059X001010283595 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20265500 | 10ml:1g | Category B (乙) | XG04BXZ059X001010283611 | NHSA |
| 江苏百奥信康医药科技有限公司 | 国药准字H20249495 | 10ml:1g | Category B (乙) | XG04BXZ059X001010284329 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20249009 | 10ml:1g | Category B (乙) | XG04BXZ059X001010285253 | NHSA |
| 江苏天平药业有限公司 | 国药准字H20264835 | 10ml∶1g | Category B (乙) | XG04BXZ059X001010286360 | NHSA |
| 大连美罗中药厂有限公司 | 国药准字H20103448 | 10ml:1g | Category B (乙) | XG04BXZ059X001010301123 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H20254544 | 10ml:1g | Category B (乙) | XG04BXZ059X001010303421 | NHSA |
| 哈尔滨誉衡制药有限公司 | 国药准字H20255544 | 10ml:1g | Category B (乙) | XG04BXZ059X001010303687 | NHSA |
| 山东益康药业股份有限公司 | 国药准字H20203109 | 10ml:1g | Category B (乙) | XG04BXZ059X001010304193 | NHSA |
| 西洲医药科技(浙江)有限公司 | 国药准字H20244005 | 10ml:1g | Category B (乙) | XG04BXZ059X001010304610 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20265285 | 10ml:1g | Category B (乙) | XG04BXZ059X001010304685 | NHSA |
| 湖南明瑞制药股份有限公司 | 国药准字H20173337 | 10ml:1g | Category B (乙) | XG04BXZ059X001010305001 | NHSA |
| 北京康祯生物科技有限公司 | 国药准字H20249135 | 10ml:1g | Category B (乙) | XG04BXZ059X001010309198 | NHSA |
| 辽宁诺维诺制药股份有限公司 | 国药准字H20254713 | 10ml:1g | Category B (乙) | XG04BXZ059X001010310029 | NHSA |
| 北京诚济制药股份有限公司 | 国药准字H20193098 | 10ml:1g | Category B (乙) | XG04BXZ059X001010382209 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20254529 | 10ml:1g | Category B (乙) | XG04BXZ059X001010383595 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20265500 | 10ml:1g | Category B (乙) | XG04BXZ059X001010383611 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20249009 | 10ml:1g | Category B (乙) | XG04BXZ059X001010385253 | NHSA |
| 江苏天平药业有限公司 | 国药准字H20264835 | 10ml∶1g | Category B (乙) | XG04BXZ059X001010386360 | NHSA |
| 大连美罗中药厂有限公司 | 国药准字H20103448 | 10ml:1g | Category B (乙) | XG04BXZ059X001010401123 | NHSA |
| 吉林省辉南长龙生化药业股份有限公司 | 国药准字H20254544 | 10ml:1g | Category B (乙) | XG04BXZ059X001010403421 | NHSA |
| 哈尔滨誉衡制药有限公司 | 国药准字H20255544 | 10ml:1g | Category B (乙) | XG04BXZ059X001010403687 | NHSA |
| 湖南明瑞制药股份有限公司 | 国药准字H20173337 | 10ml:1g | Category B (乙) | XG04BXZ059X001010405001 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20254529 | 10ml:1g | Category B (乙) | XG04BXZ059X001010483595 | NHSA |
| 江苏广承药业有限公司 | 国药准字H20265500 | 10ml:1g | Category B (乙) | XG04BXZ059X001010483611 | NHSA |
| 江苏天平药业有限公司 | 国药准字H20264835 | 10ml∶1g | Category B (乙) | XG04BXZ059X001010486360 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20254529 | 10ml:1g | Category B (乙) | XG04BXZ059X001010583595 | NHSA |
| 江苏天平药业有限公司 | 国药准字H20264835 | 10ml∶1g | Category B (乙) | XG04BXZ059X001010586360 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20254529 | 10ml:1g | Category B (乙) | XG04BXZ059X001010683595 | NHSA |
| 东北制药集团沈阳第一制药有限公司 | 国药准字H19990372 | 10ml:1g | Category B (乙) | XG04BXZ059X001020101162 | NHSA |
| 山东齐都药业有限公司 | 国药准字H20123100 | 10ml:1g | Category B (乙) | XG04BXZ059X001020104145 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20265284 | 10ml:2g | Category B (乙) | XG04BXZ059X001020104685 | NHSA |
| 辽宁诺维诺制药股份有限公司 | 国药准字H20254714 | 10ml:2g | Category B (乙) | XG04BXZ059X001020110029 | NHSA |
| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | H20171058 | 10ml:2g | Category B (乙) | XG04BXZ059X001020178871 | NHSA |
| ALFASIGMA S.p.A. | 国药准字HJ20171308 | 10ml: 2g | Category B (乙) | XG04BXZ059X001020182194 | NHSA |
| 舒美奇成都生物科技有限公司 | 国药准字H20244179 | 10ml:2g | Category B (乙) | XG04BXZ059X001020183337 | NHSA |
| 东北制药集团沈阳第一制药有限公司 | 国药准字H19990372 | 10ml:1g | Category B (乙) | XG04BXZ059X001020201162 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20265284 | 10ml:2g | Category B (乙) | XG04BXZ059X001020204685 | NHSA |
| 辽宁诺维诺制药股份有限公司 | 国药准字H20254714 | 10ml:2g | Category B (乙) | XG04BXZ059X001020210029 | NHSA |
| ALFASIGMA S.p.A. | 国药准字HJ20171308 | 10ml: 2g | Category B (乙) | XG04BXZ059X001020282194 | NHSA |
| 舒美奇成都生物科技有限公司 | 国药准字H20244179 | 10ml:2g | Category B (乙) | XG04BXZ059X001020283337 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20265284 | 10ml:2g | Category B (乙) | XG04BXZ059X001020304685 | NHSA |
| 舒美奇成都生物科技有限公司 | 国药准字H20244179 | 10ml:2g | Category B (乙) | XG04BXZ059X001020383337 | 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: 9 filings and 8 distinct first applicants.
Generic 9
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 云南海沣药业有限公司 | CYHS2602332 | Generic | 2026/09/18 | Not stated by source | CDE |
| 锦州本天药业有限公司 | CYHS2504414 | Generic | 2025/12/26 | Not stated by source | CDE |
| 湖南华纳大药厂股份有限公司 | CYHS2504325 | Generic | 2025/12/19 | Not stated by source | CDE |
| 北京六环药业有限公司;华夏生生药业（北京）有限公司 | CYHS2503485 | Generic | 2025/09/22 | Not stated by source | CDE |
| 北京六环药业有限公司;华夏生生药业（北京）有限公司 | CYHS2503484 | Generic | 2025/09/22 | Not stated by source | CDE |
| 山东康林医药有限公司;山东益康药业股份有限公司 | CYHS2503224 | Generic | 2025/09/02 | Not stated by source | CDE |
| 江西施美药业股份有限公司 | CYHS2502276 | Generic | 2025/06/26 | Not stated by source | CDE |
| 黑龙江中桂制药有限公司 | CYHS2502061 | Generic | 2025/06/11 | Not stated by source | CDE |
| 江西众泽源医药科技有限公司;安徽永生堂药业有限责任公司 | CYHS2602672 | Generic | 2026/11/02 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 11 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| 左卡尼汀 | 吉林省四合药业科技有限公司 | Y20230001159 | A | Exact ingredient | 2025/07/21 | CDE |
| 左卡尼汀 | 浙江竹子制药有限公司 | Y20230001188 | A | Exact ingredient | 2026/07/28 | CDE |
| 左卡尼汀 | 山东齐都药业有限公司 | Y20230001051 | A | Exact ingredient | 2025/08/19 | CDE |
| 左卡尼汀 | 海南卓科制药有限公司 | Y20230000689 | A | Exact ingredient | 2025/04/16 | CDE |
| 左卡尼汀 | 吉林省辉南长龙生化药业股份有限公司 | Y20220001204 | A | Exact ingredient | 2025/02/28 | CDE |
| 左卡尼汀 | 泓博智源（开原）药业有限公司 | Y20210001266 | A | Exact ingredient | 2025/09/04 | CDE |
| 左卡尼汀 | 上海博腾智拓医药科技有限公司 | Y20210000770 | A | Exact ingredient | 2024/11/12 | CDE |
| 左卡尼汀 | 诚达药业股份有限公司 | Y20200000014 | A | Exact ingredient | 2023/05/24 | CDE |
| 左卡尼汀 | 常州兰陵制药有限公司 | Y20190003752 | A | Exact ingredient | 2026/10/09 | CDE |
| 左卡尼汀 | 东北制药集团股份有限公司 | Y20190003163 | A | Exact ingredient | 2024/04/24 | CDE |
| 左卡尼汀 | 山东齐都药业有限公司 | Y20170001602 | A | Exact ingredient | 2025/08/23 | CDE |
| 左卡尼汀 | 辽宁诺维诺制药股份有限公司 | Y20170000014 | A | Exact ingredient | 2023/12/27 | 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.
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2026/11/02Accepted
江西众泽源医药科技有限公司;安徽永生堂药业有限责任公司
CYHS2602672
Fact date: 2026/11/02 · Site observation date: 2026/11/03
View source ↗ -
2026/10/23No longer listed under review
广东健信制药股份有限公司;合肥诚志生物制药有限公司
CYHS2501487
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2025/04/19
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/09/18Accepted
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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