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Sign in to subscribeAcetylcysteine Granules
As of 13 November 2026, for Acetylcysteine Granules, 4 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 19 holders.
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/13 06:42
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 holders19View records ↓
Under-review filings4View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers29View records ↓
API companies with A status12View records ↓
Chemical-drug catalogue
Loaded records: 19 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 17 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 |
|---|---|---|---|---|---|---|
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H20265343 | 2026/07/21 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H20265344 | 2026/07/21 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ou La Pharmaceuticals Technology Co., Ltd. romanized | Hunan Xin Hui Pharmaceutical Co., Ltd. romanized | 国药准字H20264992 | 2026/06/30 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | Jiangsu Cheng Kang Pharma Co., Ltd. romanized | 国药准字H20263738 | 2026/03/31 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | Jiangsu Cheng Kang Pharma Co., Ltd. romanized | 国药准字H20263739 | 2026/03/31 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhengzhou Han Dou Pharma Group Co., Ltd. romanized | Zhengzhou Han Dou Pharma Group Co., Ltd. romanized | 国药准字H20255768 | 2025/10/21 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhengzhou Han Dou Pharma Group Co., Ltd. romanized | Zhengzhou Han Dou Pharma Group Co., Ltd. romanized | 国药准字H20255767 | 2025/10/21 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20254217 | 2025/05/20 | 0.1g | Not stated by source | CDE |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20254218 | 2025/05/20 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20249427 | 2024/11/22 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Bai Ao Pharma Co., Ltd. romanized | Guangdong Bai Ao Pharma Co., Ltd. romanized | 国药准字H20030732 | 2024/11/08 | 0.2g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Haerbin Hua Rui Sheng Hua Pharma Co., Ltd. romanized | Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H20249277 | 2024/11/05 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Ya Feng Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20244740 | 2024/08/27 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | 国药准字H20247184 | 2024/08/05 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Bai Ao Pharma Co., Ltd. romanized | Guangdong Bai Ao Pharma Co., Ltd. romanized | 国药准字H20247160 | 2024/07/11 | 0.1g | 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H20243785 | 2024/05/21 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Hebei Long Hai Pharma Co., Ltd. romanized | Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20243804 | 2024/05/21 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20243786 | 2024/05/21 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20243085 | 2024/01/23 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20243084 | 2024/01/23 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Yun Bai Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20234434 | 2023/10/27 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Yun Bai Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20234433 | 2023/10/27 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | Hainan Sai Li Ke Pharma Co., Ltd. romanized | 国药准字H20234324 | 2023/10/18 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized | Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H20234160 | 2023/09/12 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | Hainan Sai Li Ke Pharma Co., Ltd. romanized | 国药准字H20233011 | 2023/01/03 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized | 国药准字H20223842 | 2022/11/15 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | 国药准字H20223846 | 2022/11/15 | 0.2g | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Jiudian Pharmaceutical Co., Ltd | Hunan Jiudian Pharmaceutical Co., Ltd | 国药准字H20223727 | 2022/10/11 | 0.1g | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Hainan Zan Bang Pharmaceutical Co., Ltd. romanized | 国药准字H20000471 | 2000/08/04 | See source | Other drug | CDE |
| Name not romanized | Hainan Zan Bang Pharmaceutical Co., Ltd. romanized | 国药准字H20000472 | 2000/08/04 | See source | Other drug | CDE |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized | Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H20269242 | 2026/09/29 | 0.2g | 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: 29 distinct approval numbers and 18 companies.
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: 4 filings and 4 distinct first applicants.
Generic 3 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized | CYHS2601886 | Generic | 2026/08/04 | Not stated by source | CDE |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | CYHS2600840 | Generic | 2026/04/11 | Not stated by source | CDE |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | CYHB2600413 | Supplement | 2026/02/28 | Not stated by source | CDE |
| Wuhan Yuan Da Hong Yuan Co., Ltd. romanized; Hubei Sheng Ba Feng Yao Hua Co., Ltd. romanized | CYHS2502924 | Generic | 2025/08/12 | 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 |
|---|---|---|---|---|---|
| Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized | CYHS2601886 | Generic | 2026/08/04 | Not stated by source | CDE |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | CYHS2600840 | Generic | 2026/04/11 | 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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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