Monthly
US$200
Billed every month
Acetylcysteine Injection(乙酰半胱氨酸注射液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 applications
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 holders8View records ↓
Under-review filings53View records ↓
This year’s generic filers6View records ↓
NHSA approval numbers11View records ↓
API companies with A status12View records ↓
Chemical-drug catalogue
Loaded records: 8 holders; 2 in the quality-and-efficacy consistency-evaluation category, and 5 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 |
|---|---|---|---|---|---|---|
| 广东君康药业有限公司 | 广东星昊药业有限公司 | 国药准字H20266134 | 2026/09/29 | 25ml：5g | 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 |
| 杭州民生药业股份有限公司 | 杭州民生药业股份有限公司 | 国药准字H20269211 | 2026/08/26 | 3ml：0.3g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 四川海梦智森生物制药有限公司 | 浙江赛默制药有限公司 | 国药准字H20269085 | 2026/04/03 | 3ml：0.3g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 江苏迪赛诺制药有限公司 | 江苏迪赛诺制药有限公司 | 国药准字H20263488 | 2026/03/03 | 25ml：5g | 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 |
| 四川上善六经医药科技有限公司 | 四川汇宇制药股份有限公司 | 国药准字H20256354 | 2025/12/22 | 25ml：5g | 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 |
| 石家庄四药有限公司 | 石家庄四药有限公司 | 国药准字H20256176 | 2025/12/09 | 25ml：5g | 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 |
| 四川海梦智森生物制药有限公司 | 海南倍特药业有限公司 | 国药准字H20258179 | 2025/09/04 | 25ml:5g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| Zambon Switzerland Ltd | Zambon S.p.A | 国药准字HJ20250055 | 2025/05/13 | 3ml:0.3g | Imported originator drug (进口原研药品) | CDE |
| 四川汇宇制药股份有限公司 | 四川汇宇制药股份有限公司 | 国药准字H20249093 | 2024/10/16 | 30ml:6g | 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: 11 distinct approval numbers and 8 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 江苏迪赛诺制药有限公司 | 国药准字H20263488 | 25ml:5g | Not stated by source | XV03ABY116B002010101495 | NHSA |
| 四川汇宇制药股份有限公司 | 国药准字H20249093 | 30ml:6g | Not stated by source | XV03ABY116B002010102317 | NHSA |
| 石家庄四药有限公司 | 国药准字H20256176 | 25ml:5g | Not stated by source | XV03ABY116B002010102763 | NHSA |
| 四川海梦智森生物制药有限公司 | 国药准字H20183104 | 20ml:4g | Not stated by source | XV03ABY116B002010104152 | NHSA |
| 杭州民生药业股份有限公司 | 国药准字H20051788 | 20ml:4g | Not stated by source | XV03ABY116B002010104494 | NHSA |
| Zambon Switzerland Ltd | 国药准字HJ20250055 | 3ml:0.3g | Not stated by source | XV03ABY116B002010178963 | NHSA |
| 山西国润制药有限公司 | 国药准字H20183359 | 20ml:4g | Not stated by source | XV03ABY116B002010181128 | NHSA |
| 四川海梦智森生物制药有限公司 | 国药准字H20258179 | 25ml:5g | Not stated by source | XV03ABY116B002010183150 | NHSA |
| 广东君康药业有限公司 | 国药准字H20266134 | 25ml:5g | Not stated by source | XV03ABY116B002010184179 | NHSA |
| 四川汇宇制药股份有限公司 | 国药准字H20249093 | 30ml:6g | Not stated by source | XV03ABY116B002010202317 | NHSA |
| 石家庄四药有限公司 | 国药准字H20256176 | 25ml:5g | Not stated by source | XV03ABY116B002010202763 | NHSA |
| 四川海梦智森生物制药有限公司 | 国药准字H20183104 | 20ml:4g | Not stated by source | XV03ABY116B002010204152 | NHSA |
| 杭州民生药业股份有限公司 | 国药准字H20051788 | 20ml:4g | Not stated by source | XV03ABY116B002010204494 | NHSA |
| 山西国润制药有限公司 | 国药准字H20183359 | 20ml:4g | Not stated by source | XV03ABY116B002010281128 | NHSA |
| 四川海梦智森生物制药有限公司 | 国药准字H20183104 | 20ml:4g | Not stated by source | XV03ABY116B002010304152 | NHSA |
| 杭州民生药业股份有限公司 | 国药准字H20269211 | 3ml:0.3g | Not stated by source | XV03ABY116B002020104494 | NHSA |
| 四川海梦智森生物制药有限公司 | 国药准字H20269085 | 3ml:0.3g | Not stated by source | XV03ABY116B002020183150 | NHSA |
| 杭州民生药业股份有限公司 | 国药准字H20269211 | 3ml:0.3g | Not stated by source | XV03ABY116B002020204494 | 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: 53 filings and 52 distinct first applicants.
Generic 52 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京正大天晴制药有限公司 | CYHS2502107 | Generic | 2025/06/12 | Not stated by source | CDE |
| 江苏润恒制药有限公司 | CYHS2500560 | Generic | 2025/02/05 | Not stated by source | CDE |
| 德全药品（江苏）股份有限公司 | CYHS2502092 | Generic | 2025/06/12 | Not stated by source | CDE |
| 苏州弘森药业股份有限公司 | CYHS2502353 | Generic | 2025/07/03 | Not stated by source | CDE |
| 江苏安必生制药有限公司 | CYHS2601066 | Generic | 2026/05/09 | Not stated by source | CDE |
| 江苏润邦药业有限公司;江西银涛药业股份有限公司 | CYHS2504400 | Generic | 2025/12/25 | Not stated by source | CDE |
| 江苏宝东医药科技有限公司;哈尔滨誉衡制药有限公司 | CYHS2502209 | Generic | 2025/06/20 | Not stated by source | CDE |
| 博智安健（河北）药业有限公司;裕松源药业有限公司 | CYHS2602192 | Generic | 2026/09/02 | Not stated by source | CDE |
| 海南全星制药有限公司 | CYHS2601821 | Generic | 2026/07/29 | Not stated by source | CDE |
| 安徽新世纪药业有限公司;马鞍山丰原制药有限公司 | CYHS2600765 | Generic | 2026/04/02 | Not stated by source | CDE |
| 湖北午时药业股份有限公司 | CYHS2600625 | Generic | 2026/03/07 | Not stated by source | CDE |
| 山东新华鲁抗医药有限公司;山东罗欣药业集团股份有限公司 | CYHS2600596 | Generic | 2026/03/02 | Not stated by source | CDE |
| 成都华宇制药有限公司 | CYHS2503871 | Generic | 2025/11/05 | Not stated by source | CDE |
| 海南葫芦娃药业集团股份有限公司 | CYHS2503497 | Generic | 2025/09/24 | Not stated by source | CDE |
| 重庆康刻尔制药股份有限公司;成都百裕制药股份有限公司 | CYHS2502910 | Generic | 2025/08/11 | Not stated by source | CDE |
| 武汉先路医药科技股份有限公司;朗天药业（湖北）有限公司 | CYHS2502898 | Generic | 2025/08/09 | Not stated by source | CDE |
| 海口天行健药物研究有限公司;海南爱科制药有限公司 | CYHS2502769 | Generic | 2025/08/01 | Not stated by source | CDE |
| 海南爱科制药有限公司 | CYHS2502692 | Generic | 2025/07/25 | Not stated by source | CDE |
| 四川天杏汇医药科技有限公司;成都天台山制药股份有限公司 | CYHS2502542 | Generic | 2025/07/16 | Not stated by source | CDE |
| 济南康桥医药科技有限公司;山东豪瑞恩制药有限公司 | CYHS2502541 | Generic | 2025/07/16 | Not stated by source | CDE |
| 四川美大康华康药业有限公司 | CYHS2502360 | Generic | 2025/07/04 | Not stated by source | CDE |
| 合肥力成药业有限公司 | CYHS2502323 | Generic | 2025/06/30 | Not stated by source | CDE |
| 山西阳和医药技术有限公司;山西国润制药有限公司 | CYHS2502321 | Generic | 2025/06/30 | Not stated by source | CDE |
| 四川信拓医药技术有限公司;成都百裕制药股份有限公司 | CYHS2502303 | Generic | 2025/06/27 | Not stated by source | CDE |
| 山东如至生物医药科技有限公司;成都市海通药业有限公司 | CYHS2502286 | Generic | 2025/06/26 | Not stated by source | CDE |
| 安徽长江药业有限公司 | CYHS2502275 | Generic | 2025/06/25 | Not stated by source | CDE |
| 吉林敖东药业集团延吉股份有限公司 | CYHS2502274 | Generic | 2025/06/25 | Not stated by source | CDE |
| 江西银涛药业股份有限公司 | CYHS2502242 | Generic | 2025/06/21 | Not stated by source | CDE |
| 安徽金太阳生化药业有限公司 | CYHS2502232 | Generic | 2025/06/21 | Not stated by source | CDE |
| 峨眉山通惠制药有限公司 | CYHS2502211 | Generic | 2025/06/20 | Not stated by source | CDE |
| 安徽茂康药业有限公司;成都市海通药业有限公司 | CYHS2502199 | Generic | 2025/06/19 | Not stated by source | CDE |
| 福安药业集团庆余堂制药有限公司 | CYHS2502185 | Generic | 2025/06/18 | Not stated by source | CDE |
| 石家庄四药有限公司 | CYHS2502117 | Generic | 2025/06/12 | Not stated by source | CDE |
| 湖南华纳大药厂股份有限公司 | CYHS2502109 | Generic | 2025/06/12 | Not stated by source | CDE |
| 海南金瑞宝医药科技有限公司;海南海灵化学制药有限公司 | CYHS2502098 | Generic | 2025/06/12 | Not stated by source | CDE |
| 远大医药（中国）有限公司 | CYHS2502082 | Generic | 2025/06/12 | Not stated by source | CDE |
| 成都倍特药业股份有限公司 | CYHS2502081 | Generic | 2025/06/12 | Not stated by source | CDE |
| 仁合益康集团有限公司;河北仁合益康药业有限公司 | CYHS2502056 | Generic | 2025/06/11 | Not stated by source | CDE |
| 河北龙海药业股份有限公司;石家庄凯达生物工程有限公司 | CYHS2502054 | Generic | 2025/06/11 | Not stated by source | CDE |
| 海南斯达制药有限公司 | CYHS2502053 | Generic | 2025/06/11 | Not stated by source | CDE |
| 上海凯宝新谊（新乡）药业有限公司 | CYHS2502051 | Generic | 2025/06/11 | Not stated by source | CDE |
| 江西科睿药业有限公司;江西青峰药业有限公司 | CYHS2502048 | Generic | 2025/06/10 | Not stated by source | CDE |
| 山东如至生物医药科技有限公司;山东豪瑞恩制药有限公司 | CYHS2502043 | Generic | 2025/06/10 | Not stated by source | CDE |
| 舒美奇成都生物科技有限公司;四川美大康佳乐药业有限公司 | CYHS2502013 | Generic | 2025/06/06 | Not stated by source | CDE |
| 西藏诺泽生物医药有限公司;成都市海通药业有限公司 | CYHS2501979 | Generic | 2025/06/05 | Not stated by source | CDE |
| 长春澜江医药科技有限公司;太极集团四川太极制药有限公司 | CYHS2501957 | Generic | 2025/05/31 | Not stated by source | CDE |
| 湖北津药药业股份有限公司 | CYHS2501950 | Generic | 2025/05/31 | Not stated by source | CDE |
| 合肥启旸生物医药科技有限公司;平光制药股份有限公司 | CYHS2501945 | Generic | 2025/05/31 | Not stated by source | CDE |
| 浙江赛默制药有限公司 | CYHS2501920 | Generic | 2025/05/29 | Not stated by source | CDE |
| 四川科伦药业股份有限公司 | CYHS2501919 | Generic | 2025/05/29 | Not stated by source | CDE |
| 广州大光制药有限公司;广东星昊药业有限公司 | CYHS2501917 | Generic | 2025/05/29 | Not stated by source | CDE |
| 广州君博医药科技有限公司;广东星昊药业有限公司 | CYHS2501915 | Generic | 2025/05/29 | Not stated by source | CDE |
| 杭州民生药业股份有限公司 | CYHB2650208 | Supplement | 2026/10/22 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 6 filings and 6 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏安必生制药有限公司 | CYHS2601066 | Generic | 2026/05/09 | Not stated by source | CDE |
| 博智安健（河北）药业有限公司;裕松源药业有限公司 | CYHS2602192 | Generic | 2026/09/02 | Not stated by source | CDE |
| 海南全星制药有限公司 | CYHS2601821 | Generic | 2026/07/29 | Not stated by source | CDE |
| 安徽新世纪药业有限公司;马鞍山丰原制药有限公司 | CYHS2600765 | Generic | 2026/04/02 | Not stated by source | CDE |
| 湖北午时药业股份有限公司 | CYHS2600625 | Generic | 2026/03/07 | Not stated by source | CDE |
| 山东新华鲁抗医药有限公司;山东罗欣药业集团股份有限公司 | CYHS2600596 | Generic | 2026/03/02 | Not stated by source | CDE |
API registrations
Non-component matches: 12 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 |
|---|---|---|---|---|---|---|
| 乙酰半胱氨酸 | 浙江海昌药业股份有限公司 | Y20260000718 | I | Exact ingredient | 2026/08/14 | CDE |
| 乙酰半胱氨酸 | PharmaZell GmbH | Y20250001320 | I | Exact ingredient | 2026/04/28 | CDE |
| 乙酰半胱氨酸 | 浙江海洲制药股份有限公司 | Y20260000217 | I | Exact ingredient | 2026/03/27 | CDE |
| 乙酰半胱氨酸 | 津药药业股份有限公司 | Y20240001520 | I | Exact ingredient | 2025/05/28 | CDE |
| 乙酰半胱氨酸 | 湖南九典宏阳制药有限公司 | Y20240001419 | A | Exact ingredient | 2026/09/10 | CDE |
| 乙酰半胱氨酸 | 浙江金华康恩贝生物制药有限公司 | Y20240001287 | A | Exact ingredient | 2026/06/02 | CDE |
| 乙酰半胱氨酸 | 湖南华纳大药厂手性药物有限公司 | Y20230001045 | A | Exact ingredient | 2025/05/20 | CDE |
| 乙酰半胱氨酸 | 浙江诚意药业股份有限公司 | Y20220000261 | A | Exact ingredient | 2024/05/22 | CDE |
| 乙酰半胱氨酸 | 七星化学制药股份有限公司 | Y20220000066 | A | Exact ingredient | 2024/01/25 | CDE |
| 乙酰半胱氨酸 | 山西阳和药业有限公司 | Y20210001235 | A | Exact ingredient | 2025/02/06 | CDE |
| 乙酰半胱氨酸 | 福建南方制药股份有限公司 | Y20210001183 | A | Exact ingredient | 2024/09/17 | CDE |
| 乙酰半胱氨酸 | 浙江赛默制药有限公司 | Y20210001203 | A | Exact ingredient | 2025/10/18 | CDE |
| 乙酰半胱氨酸 | Nippon Rika Co., Ltd. | Y20200000078 | A | Exact ingredient | 2023/03/24 | CDE |
| 乙酰半胱氨酸 | 武汉远大弘元股份有限公司 | Y20190009549 | A | Exact ingredient | 2025/09/24 | CDE |
| 乙酰半胱氨酸 | F.I.S. Fabbrica Italiana Sintetici S.P.A. | Y20190009052 | A | Exact ingredient | 2024/05/22 | CDE |
| 乙酰半胱氨酸 | 浙江诚意药业股份有限公司 | Y20190007528 | A | Exact ingredient | 2024/05/22 | CDE |
| 乙酰半胱氨酸 | 湖北新生源生物工程有限公司 | Y20190006101 | A | Exact ingredient | 2026/01/29 | CDE |
| 乙酰半胱氨酸 | MOEHS IBERICA S.L. | Y20170000715 | I | 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.
-
2026/10/22Accepted
-
2026/09/02Accepted
博智安健（河北）药业有限公司;裕松源药业有限公司
CYHS2602192
Fact date: 2026/09/02 · Site observation date: 2026/10/22
View source ↗
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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- Increase your follow limit from 3 to 10 products.
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US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
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