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As of 13 November 2026, for Acetylcysteine Injection, 53 applications are listed as under review at China's CDE; 6 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 8 holders.
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.
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 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 |
|---|---|---|---|---|---|---|
| Guangdong Jun Kang Pharma Co., Ltd. romanized | Guangdong Sunho Pharmaceutical Co., Ltd. | 国药准字H20266134 | 2026/09/29 | 25ml：5g | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H20269211 | 2026/08/26 | 3ml：0.3g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20269085 | 2026/04/03 | 3ml：0.3g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20263488 | 2026/03/03 | 25ml：5g | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20256354 | 2025/12/22 | 25ml：5g | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20256176 | 2025/12/09 | 25ml：5g | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized | Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20258179 | 2025/09/04 | 25ml:5g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Zambon Switzerland Ltd | Zambon S.p.A | 国药准字HJ20250055 | 2025/05/13 | 3ml:0.3g | Imported originator drug | CDE |
| Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20249093 | 2024/10/16 | 30ml:6g | 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: 11 distinct approval numbers and 8 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20263488 | 25ml:5g | Not stated by source | XV03ABY116B002010101495 | NHSA |
| Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20249093 | 30ml:6g | Not stated by source | XV03ABY116B002010102317 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20256176 | 25ml:5g | Not stated by source | XV03ABY116B002010102763 | NHSA |
| Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized | 国药准字H20183104 | 20ml:4g | Not stated by source | XV03ABY116B002010104152 | NHSA |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 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 |
| Shanxi Guo Run Pharmaceutical Co., Ltd. romanized | 国药准字H20183359 | 20ml:4g | Not stated by source | XV03ABY116B002010181128 | NHSA |
| Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized | 国药准字H20258179 | 25ml:5g | Not stated by source | XV03ABY116B002010183150 | NHSA |
| Guangdong Jun Kang Pharma Co., Ltd. romanized | 国药准字H20266134 | 25ml:5g | Not stated by source | XV03ABY116B002010184179 | NHSA |
| Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20249093 | 30ml:6g | Not stated by source | XV03ABY116B002010202317 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20256176 | 25ml:5g | Not stated by source | XV03ABY116B002010202763 | NHSA |
| Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized | 国药准字H20183104 | 20ml:4g | Not stated by source | XV03ABY116B002010204152 | NHSA |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H20051788 | 20ml:4g | Not stated by source | XV03ABY116B002010204494 | NHSA |
| Shanxi Guo Run Pharmaceutical Co., Ltd. romanized | 国药准字H20183359 | 20ml:4g | Not stated by source | XV03ABY116B002010281128 | NHSA |
| Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized | 国药准字H20183104 | 20ml:4g | Not stated by source | XV03ABY116B002010304152 | NHSA |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H20269211 | 3ml:0.3g | Not stated by source | XV03ABY116B002020104494 | NHSA |
| Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized | 国药准字H20269085 | 3ml:0.3g | Not stated by source | XV03ABY116B002020183150 | NHSA |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 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
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 |
|---|---|---|---|---|---|
| Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized | CYHS2601066 | Generic | 2026/05/09 | Not stated by source | CDE |
| Bo Zhi An Jian (Hebei) Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized | CYHS2602192 | Generic | 2026/09/02 | Not stated by source | CDE |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | CYHS2601821 | Generic | 2026/07/29 | Not stated by source | CDE |
| Anhui Xin Shi Ji Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized | CYHS2600765 | Generic | 2026/04/02 | Not stated by source | CDE |
| Hubei Wu Shi Pharma Co., Ltd. romanized | CYHS2600625 | Generic | 2026/03/07 | Not stated by source | CDE |
| Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized | 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 · No verified English name | Zhejiang Hai Chang Pharma Co., Ltd. romanized | Y20260000718 | I | Exact ingredient | 2026/08/14 | CDE |
| 乙酰半胱氨酸 · No verified English name | PharmaZell GmbH | Y20250001320 | I | Exact ingredient | 2026/04/28 | CDE |
| 乙酰半胱氨酸 · No verified English name | Zhejiang Hai Zhou Pharmaceutical Co., Ltd. romanized | Y20260000217 | I | Exact ingredient | 2026/03/27 | CDE |
| 乙酰半胱氨酸 · No verified English name | Jin Yao Pharma Co., Ltd. romanized | Y20240001520 | I | Exact ingredient | 2025/05/28 | CDE |
| 乙酰半胱氨酸 · No verified English name | Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20240001419 | A | Exact ingredient | 2026/09/10 | CDE |
| 乙酰半胱氨酸 · No verified English name | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | Y20240001287 | A | Exact ingredient | 2026/06/02 | CDE |
| 乙酰半胱氨酸 · No verified English name | Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized | Y20230001045 | A | Exact ingredient | 2025/05/20 | CDE |
| 乙酰半胱氨酸 · No verified English name | Zhejiang Cheng Yi Pharma Co., Ltd. romanized | Y20220000261 | A | Exact ingredient | 2024/05/22 | CDE |
| 乙酰半胱氨酸 · No verified English name | Qi Xing Chemical Pharmaceutical Co., Ltd. romanized | Y20220000066 | A | Exact ingredient | 2024/01/25 | CDE |
| 乙酰半胱氨酸 · No verified English name | Shanxi Yang He Pharma Co., Ltd. romanized | Y20210001235 | A | Exact ingredient | 2025/02/06 | CDE |
| 乙酰半胱氨酸 · No verified English name | Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20210001183 | A | Exact ingredient | 2024/09/17 | CDE |
| 乙酰半胱氨酸 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20210001203 | A | Exact ingredient | 2025/10/18 | CDE |
| 乙酰半胱氨酸 · No verified English name | Nippon Rika Co., Ltd. | Y20200000078 | A | Exact ingredient | 2023/03/24 | CDE |
| 乙酰半胱氨酸 · No verified English name | Wuhan Yuan Da Hong Yuan Co., Ltd. romanized | Y20190009549 | A | Exact ingredient | 2025/09/24 | CDE |
| 乙酰半胱氨酸 · No verified English name | F.I.S. Fabbrica Italiana Sintetici S.P.A. | Y20190009052 | A | Exact ingredient | 2024/05/22 | CDE |
| 乙酰半胱氨酸 · No verified English name | Zhejiang Cheng Yi Pharma Co., Ltd. romanized | Y20190007528 | A | Exact ingredient | 2024/05/22 | CDE |
| 乙酰半胱氨酸 · No verified English name | Hubei Xin Sheng Yuan Bio Gong Cheng Co., Ltd. romanized | Y20190006101 | A | Exact ingredient | 2026/01/29 | CDE |
| 乙酰半胱氨酸 · No verified English name | 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: 2026/11/13 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.
-
2026/10/22Accepted
Hangzhou Minsheng Pharmaceutical Co., Ltd
CYHB2650208
Fact date: 2026/10/22 · Site observation date: 2026/10/23
View source ↗ -
2026/09/02Accepted
Bo Zhi An Jian (Hebei) Pharma Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
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: 2026/11/13 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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