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Sign in to subscribeBetahistine Mesilate Tablets
As of 13 November 2026, for Betahistine Mesilate Tablets, 7 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 5 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 holders5View records ↓
Under-review filings7View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers7View records ↓
API companies with A status18View records ↓
Chemical-drug catalogue
Loaded records: 5 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 4 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 |
|---|---|---|---|---|---|---|
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | 国药准字H20264353 | 2026/05/19 | 6mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Cheng Kang Pharma Co., Ltd. romanized | Jiangsu Cheng Kang Pharma Co., Ltd. romanized | 国药准字H20263727 | 2026/03/25 | 6mg | Generic approved under the new chemical-drug registration classification | CDE |
| Xiamen En Cheng Pharmaceutical Co., Ltd. romanized | Xiamen En Cheng Pharmaceutical Co., Ltd. romanized | 国药准字H20253804 | 2025/04/01 | 6mg | 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H20244384 | 2024/07/09 | 6mg | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Wei Cai (Zhongguo) Pharma Co., Ltd. romanized | 国药准字H20040130 | 2004/01/21 | 6mg | Other drug | 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: 7 distinct approval numbers and 7 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangdong Shi Xin Pharma Co., Ltd. romanized | 国药准字H20100025 | 6mg | Category A | XN07CAB046A001010100339 | NHSA |
| Wei Cai (Zhongguo) Pharma Co., Ltd. romanized | 国药准字H20040130 | 6mg | Category A | XN07CAB046A001010101693 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244384 | 6mg | Category A | XN07CAB046A001010102763 | NHSA |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20264353 | 6mg | Category A | XN07CAB046A001010103662 | NHSA |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20264307 | 6mg | Category A | XN07CAB046A001010104735 | NHSA |
| Fuzhou Zhang Fu Xing Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253804 | 6mg | Category A | XN07CAB046A001010180214 | NHSA |
| Jiangsu Cheng Kang Pharma Co., Ltd. romanized | 国药准字H20263727 | 6mg | Category A | XN07CAB046A001010182219 | NHSA |
| Guangdong Shi Xin Pharma Co., Ltd. romanized | 国药准字H20100025 | 6mg | Category A | XN07CAB046A001010200339 | NHSA |
| Wei Cai (Zhongguo) Pharma Co., Ltd. romanized | 国药准字H20040130 | 6mg | Category A | XN07CAB046A001010201693 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244384 | 6mg | Category A | XN07CAB046A001010202763 | NHSA |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20264353 | 6mg | Category A | XN07CAB046A001010203662 | NHSA |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20264307 | 6mg | Category A | XN07CAB046A001010204735 | NHSA |
| Fuzhou Zhang Fu Xing Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20253804 | 6mg | Category A | XN07CAB046A001010280214 | NHSA |
| Jiangsu Cheng Kang Pharma Co., Ltd. romanized | 国药准字H20263727 | 6mg | Category A | XN07CAB046A001010282219 | NHSA |
| Wei Cai (Zhongguo) Pharma Co., Ltd. romanized | 国药准字H20040130 | 6mg | Category A | XN07CAB046A001010301693 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244384 | 6mg | Category A | XN07CAB046A001010302763 | NHSA |
| Jiangsu Cheng Kang Pharma Co., Ltd. romanized | 国药准字H20263727 | 6mg | Category A | XN07CAB046A001010382219 | NHSA |
| Wei Cai (Zhongguo) Pharma Co., Ltd. romanized | 国药准字H20040130 | 6mg | Category A | XN07CAB046A001010401693 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244384 | 6mg | Category A | XN07CAB046A001010402763 | NHSA |
| Jiangsu Cheng Kang Pharma Co., Ltd. romanized | 国药准字H20263727 | 6mg | Category A | XN07CAB046A001010482219 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244384 | 6mg | Category A | XN07CAB046A001010502763 | NHSA |
| Jiangsu Cheng Kang Pharma Co., Ltd. romanized | 国药准字H20263727 | 6mg | Category A | XN07CAB046A001010582219 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244384 | 6mg | Category A | XN07CAB046A001010602763 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244384 | 6mg | Category A | XN07CAB046A001010702763 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244384 | 6mg | Category A | XN07CAB046A001010802763 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244384 | 6mg | Category A | XN07CAB046A001010902763 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20244384 | 6mg | Category A | XN07CAB046A001011002763 | 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: 7 filings and 7 distinct first applicants.
Generic 6 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | CYHS2601731 | Generic | 2026/07/20 | Not stated by source | CDE |
| Bo Zhi An Jian (Hebei) Pharma Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized | CYHS2602276 | Generic | 2026/09/15 | Not stated by source | CDE |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | CYHS2601090 | Generic | 2026/05/13 | Not stated by source | CDE |
| Guangdong Shi Xin Pharma Co., Ltd. romanized | CYHB2650093 | Supplement | 2026/04/20 | Not stated by source | CDE |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | CYHS2600786 | Generic | 2026/04/08 | Not stated by source | CDE |
| Hebei Long Hai Pharma Co., Ltd. romanized | CYHS2503307 | Generic | 2025/09/06 | Not stated by source | CDE |
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Yuan Da Pharmaceuticals (Xian Tao) Pharmaceutical Co., Ltd. romanized | CYHS2602748 | Generic | 2026/11/09 | 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 |
|---|---|---|---|---|---|
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | CYHS2601731 | Generic | 2026/07/20 | Not stated by source | CDE |
| Bo Zhi An Jian (Hebei) Pharma Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized | CYHS2602276 | Generic | 2026/09/15 | Not stated by source | CDE |
| Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | CYHS2601090 | Generic | 2026/05/13 | Not stated by source | CDE |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | CYHS2600786 | Generic | 2026/04/08 | Not stated by source | CDE |
| Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Yuan Da Pharmaceuticals (Xian Tao) Pharmaceutical Co., Ltd. romanized | CYHS2602748 | Generic | 2026/11/09 | Not stated by source | CDE |
API registrations
Non-component matches: 18 companies with A status and 2 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 |
|---|---|---|---|---|---|---|
| 甲磺酸倍他司汀 · No verified English name | Run Dou Pharmaceutical (Jing Men) Co., Ltd. romanized | Y20250000941 | I | Exact ingredient | 2025/12/09 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Anhui Ai Li De Pharmaceutical Co., Ltd. romanized | Y20250000838 | I | Exact ingredient | 2025/08/20 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20240000850 | A | Exact ingredient | 2026/01/05 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized | Y20240000824 | A | Exact ingredient | 2026/01/05 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Henan Pu Rui Pharmaceutical Co., Ltd. romanized | Y20240000139 | A | Exact ingredient | 2025/07/11 | CDE |
| 甲磺酸倍他司汀 · No verified English name | APICHEM Laboratories Private Limited, Unit-III | Y20230000819 | A | Exact ingredient | 2026/03/22 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20230000146 | A | Exact ingredient | 2024/12/13 | CDE |
| 盐酸倍他司汀 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20230000179 | A | Salt-normalized ingredient | 2026/10/20 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20220001251 | A | Exact ingredient | 2026/09/02 | CDE |
| 盐酸倍他司汀 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20220001031 | A | Salt-normalized ingredient | 2025/10/30 | CDE |
| 盐酸倍他司汀 · No verified English name | Laboratorios Espinos Y Bofill S.A.（Lebsa） | Y20200001475 | A | Salt-normalized ingredient | 2024/01/28 | CDE |
| 盐酸倍他司汀 · No verified English name | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized | Y20200001402 | A | Salt-normalized ingredient | 2025/03/04 | CDE |
| 盐酸倍他司汀 · No verified English name | COHANCE LIFESCIENCES LIMITED | Y20200000965 | A | Salt-normalized ingredient | 2025/03/09 | CDE |
| 盐酸倍他司汀 · No verified English name | Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20200001060 | A | Salt-normalized ingredient | 2025/12/31 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Tokuyama Corporation | Y20190009122 | A | Exact ingredient | 2024/10/29 | CDE |
| 盐酸倍他司汀 · No verified English name | Jin Zhou Jiu Tai Pharma Co., Ltd. romanized | Y20190003821 | A | Salt-normalized ingredient | 2025/05/13 | CDE |
| 盐酸倍他司汀 · No verified English name | Shanghai Zhong Xi San Wei Pharma Co., Ltd. romanized | Y20190002829 | A | Salt-normalized ingredient | 2025/03/04 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Guangdong Shi Xin Pharma Co., Ltd. romanized | Y20190001636 | A | Exact ingredient | 2024/12/14 | CDE |
| 盐酸倍他司汀 · No verified English name | Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized | Y20170001176 | A | Salt-normalized ingredient | 2026/01/01 | CDE |
| 盐酸倍他司汀 · No verified English name | AMI LIFESCIENCES PVT. LTD. | Y20170001070 | A | Salt-normalized ingredient | 2025/04/28 | CDE |
| 甲磺酸倍他司汀 · No verified English name | Xiamen En Cheng Pharmaceutical Co., Ltd. romanized | Y20170000962 | A | Exact ingredient | 2024/04/02 | CDE |
| 盐酸倍他司汀 · No verified English name | Henan Pu Rui Pharmaceutical Co., Ltd. romanized | Y20170000885 | A | Salt-normalized ingredient | 2024/09/11 | CDE |
| 盐酸倍他司汀 · No verified English name | APICHEM Laboratories Private Limited | Y20170000391 | A | Salt-normalized ingredient | 2025/11/14 | 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.
-
2026/11/09Accepted
Ka Wen Di Xu (Tai Zhou) Pharma Co., Ltd. romanized; Yuan Da Pharmaceuticals (Xian Tao) Pharmaceutical Co., Ltd. romanized
CYHS2602748
Fact date: 2026/11/09 · Site observation date: 2026/11/10
View source ↗ -
2026/09/15Accepted
Bo Zhi An Jian (Hebei) Pharma Co., Ltd. romanized; Yi Ling Wan Zhou International Pharmaceutical Co., Ltd. romanized
CYHS2602276
Fact date: 2026/09/15 · 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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