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Betahistine Mesilate Tablets(甲磺酸倍他司汀片)
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 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 |
|---|---|---|---|---|---|---|
| 哈尔滨三联药业股份有限公司 | 兰西哈三联制药有限公司 | 国药准字H20264353 | 2026/05/19 | 6mg | 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 |
| 江苏诚康药业有限公司 | 江苏诚康药业有限公司 | 国药准字H20263727 | 2026/03/25 | 6mg | 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 |
| 厦门恩成制药有限公司 | 厦门恩成制药有限公司 | 国药准字H20253804 | 2025/04/01 | 6mg | 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H20244384 | 2024/07/09 | 6mg | 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 |
| — | 卫材（中国）药业有限公司 | 国药准字H20040130 | 2004/01/21 | 6mg | Other drug (其他药品) | 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: 7 distinct approval numbers and 7 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 广东世信药业有限公司 | 国药准字H20100025 | 6mg | Category A (甲) | XN07CAB046A001010100339 | NHSA |
| 卫材(中国)药业有限公司 | 国药准字H20040130 | 6mg | Category A (甲) | XN07CAB046A001010101693 | NHSA |
| 石家庄四药有限公司 | 国药准字H20244384 | 6mg | Category A (甲) | XN07CAB046A001010102763 | NHSA |
| 哈尔滨三联药业股份有限公司 | 国药准字H20264353 | 6mg | Category A (甲) | XN07CAB046A001010103662 | NHSA |
| 浙江仙琚制药股份有限公司 | 国药准字H20264307 | 6mg | Category A (甲) | XN07CAB046A001010104735 | NHSA |
| 福州长富星生物医药科技有限公司 | 国药准字H20253804 | 6mg | Category A (甲) | XN07CAB046A001010180214 | NHSA |
| 江苏诚康药业有限公司 | 国药准字H20263727 | 6mg | Category A (甲) | XN07CAB046A001010182219 | NHSA |
| 广东世信药业有限公司 | 国药准字H20100025 | 6mg | Category A (甲) | XN07CAB046A001010200339 | NHSA |
| 卫材(中国)药业有限公司 | 国药准字H20040130 | 6mg | Category A (甲) | XN07CAB046A001010201693 | NHSA |
| 石家庄四药有限公司 | 国药准字H20244384 | 6mg | Category A (甲) | XN07CAB046A001010202763 | NHSA |
| 哈尔滨三联药业股份有限公司 | 国药准字H20264353 | 6mg | Category A (甲) | XN07CAB046A001010203662 | NHSA |
| 浙江仙琚制药股份有限公司 | 国药准字H20264307 | 6mg | Category A (甲) | XN07CAB046A001010204735 | NHSA |
| 福州长富星生物医药科技有限公司 | 国药准字H20253804 | 6mg | Category A (甲) | XN07CAB046A001010280214 | NHSA |
| 江苏诚康药业有限公司 | 国药准字H20263727 | 6mg | Category A (甲) | XN07CAB046A001010282219 | NHSA |
| 卫材(中国)药业有限公司 | 国药准字H20040130 | 6mg | Category A (甲) | XN07CAB046A001010301693 | NHSA |
| 石家庄四药有限公司 | 国药准字H20244384 | 6mg | Category A (甲) | XN07CAB046A001010302763 | NHSA |
| 江苏诚康药业有限公司 | 国药准字H20263727 | 6mg | Category A (甲) | XN07CAB046A001010382219 | NHSA |
| 卫材(中国)药业有限公司 | 国药准字H20040130 | 6mg | Category A (甲) | XN07CAB046A001010401693 | NHSA |
| 石家庄四药有限公司 | 国药准字H20244384 | 6mg | Category A (甲) | XN07CAB046A001010402763 | NHSA |
| 江苏诚康药业有限公司 | 国药准字H20263727 | 6mg | Category A (甲) | XN07CAB046A001010482219 | NHSA |
| 石家庄四药有限公司 | 国药准字H20244384 | 6mg | Category A (甲) | XN07CAB046A001010502763 | NHSA |
| 江苏诚康药业有限公司 | 国药准字H20263727 | 6mg | Category A (甲) | XN07CAB046A001010582219 | NHSA |
| 石家庄四药有限公司 | 国药准字H20244384 | 6mg | Category A (甲) | XN07CAB046A001010602763 | NHSA |
| 石家庄四药有限公司 | 国药准字H20244384 | 6mg | Category A (甲) | XN07CAB046A001010702763 | NHSA |
| 石家庄四药有限公司 | 国药准字H20244384 | 6mg | Category A (甲) | XN07CAB046A001010802763 | NHSA |
| 石家庄四药有限公司 | 国药准字H20244384 | 6mg | Category A (甲) | XN07CAB046A001010902763 | NHSA |
| 石家庄四药有限公司 | 国药准字H20244384 | 6mg | Category A (甲) | 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 |
|---|---|---|---|---|---|
| 南京易亨制药有限公司 | CYHS2601731 | Generic | 2026/07/20 | Not stated by source | CDE |
| 博智安健（河北）药业有限公司;以岭万洲国际制药有限公司 | CYHS2602276 | Generic | 2026/09/15 | Not stated by source | CDE |
| 珠海润都制药股份有限公司 | CYHS2601090 | Generic | 2026/05/13 | Not stated by source | CDE |
| 广东世信药业有限公司 | CYHB2650093 | Supplement | 2026/04/20 | Not stated by source | CDE |
| 云鹏医药集团有限公司 | CYHS2600786 | Generic | 2026/04/08 | Not stated by source | CDE |
| 河北龙海药业股份有限公司 | CYHS2503307 | Generic | 2025/09/06 | Not stated by source | CDE |
| 卡文迪许（泰州）药业有限公司;远大医药(仙桃)制药有限公司 | 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 |
|---|---|---|---|---|---|
| 南京易亨制药有限公司 | CYHS2601731 | Generic | 2026/07/20 | Not stated by source | CDE |
| 博智安健（河北）药业有限公司;以岭万洲国际制药有限公司 | CYHS2602276 | Generic | 2026/09/15 | Not stated by source | CDE |
| 珠海润都制药股份有限公司 | CYHS2601090 | Generic | 2026/05/13 | Not stated by source | CDE |
| 云鹏医药集团有限公司 | CYHS2600786 | Generic | 2026/04/08 | Not stated by source | CDE |
| 卡文迪许（泰州）药业有限公司;远大医药(仙桃)制药有限公司 | 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 | 润都制药（荆门）有限公司 | Y20250000941 | I | Exact ingredient | 2025/12/09 | CDE |
| 甲磺酸倍他司汀 | 安徽艾立德制药有限公司 | Y20250000838 | I | Exact ingredient | 2025/08/20 | CDE |
| 甲磺酸倍他司汀 | 浙江仙琚制药股份有限公司 | Y20240000850 | A | Exact ingredient | 2026/01/05 | CDE |
| 甲磺酸倍他司汀 | 白云山东泰商丘药业有限公司 | Y20240000824 | A | Exact ingredient | 2026/01/05 | CDE |
| 甲磺酸倍他司汀 | 河南普瑞制药有限公司 | Y20240000139 | A | Exact ingredient | 2025/07/11 | CDE |
| 甲磺酸倍他司汀 | APICHEM Laboratories Private Limited, Unit-III | Y20230000819 | A | Exact ingredient | 2026/03/22 | CDE |
| 甲磺酸倍他司汀 | 兰西哈三联制药有限公司 | Y20230000146 | A | Exact ingredient | 2024/12/13 | CDE |
| 盐酸倍他司汀 | 河北国龙制药有限公司 | Y20230000179 | A | Salt-normalized ingredient | 2026/10/20 | CDE |
| 甲磺酸倍他司汀 | 河北国龙制药有限公司 | Y20220001251 | A | Exact ingredient | 2026/09/02 | CDE |
| 盐酸倍他司汀 | 兰西哈三联制药有限公司 | Y20220001031 | A | Salt-normalized ingredient | 2025/10/30 | CDE |
| 盐酸倍他司汀 | Laboratorios Espinos Y Bofill S.A.（Lebsa） | Y20200001475 | A | Salt-normalized ingredient | 2024/01/28 | CDE |
| 盐酸倍他司汀 | 国药集团国瑞药业有限公司 | Y20200001402 | A | Salt-normalized ingredient | 2025/03/04 | CDE |
| 盐酸倍他司汀 | COHANCE LIFESCIENCES LIMITED | Y20200000965 | A | Salt-normalized ingredient | 2025/03/09 | CDE |
| 盐酸倍他司汀 | 浙江乐普药业股份有限公司 | Y20200001060 | A | Salt-normalized ingredient | 2025/12/31 | CDE |
| 甲磺酸倍他司汀 | Tokuyama Corporation | Y20190009122 | A | Exact ingredient | 2024/10/29 | CDE |
| 盐酸倍他司汀 | 锦州九泰药业有限公司 | Y20190003821 | A | Salt-normalized ingredient | 2025/05/13 | CDE |
| 盐酸倍他司汀 | 上海中西三维药业有限公司 | Y20190002829 | A | Salt-normalized ingredient | 2025/03/04 | CDE |
| 甲磺酸倍他司汀 | 广东世信药业有限公司 | Y20190001636 | A | Exact ingredient | 2024/12/14 | CDE |
| 盐酸倍他司汀 | 上海现代哈森（商丘）药业有限公司 | Y20170001176 | A | Salt-normalized ingredient | 2026/01/01 | CDE |
| 盐酸倍他司汀 | AMI LIFESCIENCES PVT. LTD. | Y20170001070 | A | Salt-normalized ingredient | 2025/04/28 | CDE |
| 甲磺酸倍他司汀 | 厦门恩成制药有限公司 | Y20170000962 | A | Exact ingredient | 2024/04/02 | CDE |
| 盐酸倍他司汀 | 河南普瑞制药有限公司 | Y20170000885 | A | Salt-normalized ingredient | 2024/09/11 | CDE |
| 盐酸倍他司汀 | 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/11/09Accepted
卡文迪许（泰州）药业有限公司;远大医药(仙桃)制药有限公司
CYHS2602748
Fact date: 2026/11/09 · Site observation date: 2026/11/10
View source ↗ -
2026/09/15Accepted
博智安健（河北）药业有限公司;以岭万洲国际制药有限公司
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: 2026/11/10 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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