Monthly
US$200
Billed every month
Betahistine Dihydrochloride Tablets(盐酸倍他司汀片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 3 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 holders6View records ↓
Under-review filings11View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers27View records ↓
API companies with A status18View records ↓
Chemical-drug catalogue
Loaded records: 6 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 2 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 |
|---|---|---|---|---|---|---|
| 上海理想制药有限公司 | 上海理想制药有限公司 | 国药准字H20265152 | 2026/07/14 | 4mg | 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 |
| 森淼（山东）药业有限公司 | 济南永宁制药股份有限公司 | 国药准字H20269094 | 2026/04/21 | 4mg | 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 |
| 黑龙江亿达鸿药业有限公司 | 黑龙江亿达鸿药业有限公司 | 国药准字H20269089 | 2026/04/13 | 8mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 黑龙江亿达鸿药业有限公司 | 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 2026/04/13 | 4mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 上海理想制药有限公司 | 上海理想制药有限公司 | 国药准字H20263834 | 2026/04/07 | 8mg | 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 |
| 天方药业有限公司 | 天方药业有限公司 | 国药准字H20247121 | 2024/06/05 | 8mg(以C8H12N2·2HCl计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 天方药业有限公司 | 天方药业有限公司 | 国药准字H41023572 | 2024/06/05 | 4mg(以C8H12N2·2HCl计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 森淼（山东）药业有限公司 | 济南永宁制药股份有限公司 | 国药准字H20243912 | 2024/06/04 | 8mg | 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 |
| 乐普恒久远药业有限公司 | 乐普恒久远药业有限公司 | 国药准字H20205045 | 2022/02/25 | 8mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 河南中杰药业有限公司 | 河南中杰药业有限公司 | 国药准字H20217112 | 2021/11/15 | 8mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 河南中杰药业有限公司 | 河南中杰药业有限公司 | 国药准字H41023380 | 2021/11/15 | 4mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 乐普恒久远药业有限公司 | 乐普恒久远药业有限公司 | 国药准字H41022374 | 2020/11/16 | 4mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | 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: 27 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 华润紫竹药业有限公司 | 国药准字H11020414 | 4mg | Category A (甲) | XN07CAB046A001010100225 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001010100698 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H50020381 | 4mg | Category A (甲) | XN07CAB046A001010101016 | NHSA |
| 天方药业有限公司 | 国药准字H41023572 | 4mg(以C₈H₁₂N₂·2HCl计) | Category A (甲) | XN07CAB046A001010103098 | NHSA |
| 乐普恒久远药业有限公司 | 国药准字H20205045 | 8mg | Category A (甲) | XN07CAB046A001010103212 | NHSA |
| 乐普恒久远药业有限公司 | 国药准字H41022374 | 4mg | Category A (甲) | XN07CAB046A001010103213 | NHSA |
| 河南中杰药业有限公司 | 国药准字H41023380 | 4mg | Category A (甲) | XN07CAB046A001010103227 | NHSA |
| 吉林万通药业集团郑州万通复升药业股份有限公司 | 国药准字H41025663 | 4mg | Category A (甲) | XN07CAB046A001010103250 | NHSA |
| 山东力诺制药有限公司 | 国药准字H37022879 | 5mg | Category A (甲) | XN07CAB046A001010103987 | NHSA |
| 杏辉天力(杭州)药业有限公司 | 国药准字H33020459 | 5mg | Category A (甲) | XN07CAB046A001010104506 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 4mg | Category A (甲) | XN07CAB046A001010106644 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20269089 | 8mg | Category A (甲) | XN07CAB046A001010183481 | NHSA |
| 山东力诺制药有限公司 | 国药准字H20243912 | 8mg | Category A (甲) | XN07CAB046A001010184029 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001010200698 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H50020381 | 4mg | Category A (甲) | XN07CAB046A001010201016 | NHSA |
| 原研药港生物制药(沈阳)股份有限公司 | 国药准字H21020945 | 4mg | Category A (甲) | XN07CAB046A001010201304 | NHSA |
| 天方药业有限公司 | 国药准字H41023572 | 4mg(以C₈H₁₂N₂·2HCl计) | Category A (甲) | XN07CAB046A001010203098 | NHSA |
| 乐普恒久远药业有限公司 | 国药准字H20205045 | 8mg | Category A (甲) | XN07CAB046A001010203212 | NHSA |
| 乐普恒久远药业有限公司 | 国药准字H41022374 | 4mg | Category A (甲) | XN07CAB046A001010203213 | NHSA |
| 河南中杰药业有限公司 | 国药准字H41023380 | 4mg | Category A (甲) | XN07CAB046A001010203227 | NHSA |
| 吉林万通药业集团郑州万通复升药业股份有限公司 | 国药准字H41025663 | 4mg | Category A (甲) | XN07CAB046A001010203250 | NHSA |
| 山东力诺制药有限公司 | 国药准字H37022879 | 5mg | Category A (甲) | XN07CAB046A001010203987 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 4mg | Category A (甲) | XN07CAB046A001010206644 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20269089 | 8mg | Category A (甲) | XN07CAB046A001010283481 | NHSA |
| 山东力诺制药有限公司 | 国药准字H20243912 | 8mg | Category A (甲) | XN07CAB046A001010284029 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001010300698 | NHSA |
| 原研药港生物制药(沈阳)股份有限公司 | 国药准字H21020945 | 4mg | Category A (甲) | XN07CAB046A001010301304 | NHSA |
| 天方药业有限公司 | 国药准字H41023572 | 4mg(以C₈H₁₂N₂·2HCl计) | Category A (甲) | XN07CAB046A001010303098 | NHSA |
| 乐普恒久远药业有限公司 | 国药准字H20205045 | 8mg | Category A (甲) | XN07CAB046A001010303212 | NHSA |
| 乐普恒久远药业有限公司 | 国药准字H41022374 | 4mg | Category A (甲) | XN07CAB046A001010303213 | NHSA |
| 河南中杰药业有限公司 | 国药准字H41023380 | 4mg | Category A (甲) | XN07CAB046A001010303227 | NHSA |
| 吉林万通药业集团郑州万通复升药业股份有限公司 | 国药准字H41025663 | 4mg | Category A (甲) | XN07CAB046A001010303250 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 4mg | Category A (甲) | XN07CAB046A001010306644 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20269089 | 8mg | Category A (甲) | XN07CAB046A001010383481 | NHSA |
| 山东力诺制药有限公司 | 国药准字H20243912 | 8mg | Category A (甲) | XN07CAB046A001010384029 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001010400698 | NHSA |
| 原研药港生物制药(沈阳)股份有限公司 | 国药准字H21020945 | 4mg | Category A (甲) | XN07CAB046A001010401304 | NHSA |
| 乐普恒久远药业有限公司 | 国药准字H20205045 | 8mg | Category A (甲) | XN07CAB046A001010403212 | NHSA |
| 乐普恒久远药业有限公司 | 国药准字H41022374 | 4mg | Category A (甲) | XN07CAB046A001010403213 | NHSA |
| 河南中杰药业有限公司 | 国药准字H41023380 | 4mg | Category A (甲) | XN07CAB046A001010403227 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 4mg | Category A (甲) | XN07CAB046A001010406644 | NHSA |
| 山东力诺制药有限公司 | 国药准字H20243912 | 8mg | Category A (甲) | XN07CAB046A001010484029 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001010500698 | NHSA |
| 原研药港生物制药(沈阳)股份有限公司 | 国药准字H21020945 | 4mg | Category A (甲) | XN07CAB046A001010501304 | NHSA |
| 乐普恒久远药业有限公司 | 国药准字H41022374 | 4mg | Category A (甲) | XN07CAB046A001010503213 | NHSA |
| 河南中杰药业有限公司 | 国药准字H41023380 | 4mg | Category A (甲) | XN07CAB046A001010503227 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 4mg | Category A (甲) | XN07CAB046A001010506644 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001010600698 | NHSA |
| 河南中杰药业有限公司 | 国药准字H41023380 | 4mg | Category A (甲) | XN07CAB046A001010603227 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 4mg | Category A (甲) | XN07CAB046A001010606644 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001010700698 | NHSA |
| 河南中杰药业有限公司 | 国药准字H41023380 | 4mg | Category A (甲) | XN07CAB046A001010703227 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 4mg | Category A (甲) | XN07CAB046A001010706644 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001010800698 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 4mg | Category A (甲) | XN07CAB046A001010806644 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001010900698 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 4mg | Category A (甲) | XN07CAB046A001010906644 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001011000698 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H20113283 | 4mg | Category A (甲) | XN07CAB046A001011006644 | NHSA |
| 上海理想制药有限公司 | 国药准字H20263834 | 8mg | Category A (甲) | XN07CAB046A001011100698 | NHSA |
| 上海理想制药有限公司 | 国药准字H20265152 | 4mg | Category A (甲) | XN07CAB046A001020100698 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H50020381 | 4mg | Category A (甲) | XN07CAB046A001020101016 | NHSA |
| 天方药业有限公司 | 国药准字H20247121 | 8mg(以C₈H₁₂N₂·2HCl计) | Category A (甲) | XN07CAB046A001020103098 | NHSA |
| 河南中杰药业有限公司 | 国药准字H20217112 | 8mg | Category A (甲) | XN07CAB046A001020103227 | NHSA |
| 山东力诺制药有限公司 | 国药准字H37022879 | 5mg | Category A (甲) | XN07CAB046A001020103987 | NHSA |
| 山东力诺制药有限公司 | 国药准字H20269094 | 4mg | Category A (甲) | XN07CAB046A001020184029 | NHSA |
| 上海理想制药有限公司 | 国药准字H20265152 | 4mg | Category A (甲) | XN07CAB046A001020200698 | NHSA |
| 天方药业有限公司 | 国药准字H20247121 | 8mg(以C₈H₁₂N₂·2HCl计) | Category A (甲) | XN07CAB046A001020203098 | NHSA |
| 河南中杰药业有限公司 | 国药准字H20217112 | 8mg | Category A (甲) | XN07CAB046A001020203227 | NHSA |
| 山东力诺制药有限公司 | 国药准字H20269094 | 4mg | Category A (甲) | XN07CAB046A001020284029 | NHSA |
| 上海理想制药有限公司 | 国药准字H20265152 | 4mg | Category A (甲) | XN07CAB046A001020300698 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H50020381 | 4mg | Category A (甲) | XN07CAB046A001020301016 | NHSA |
| 天方药业有限公司 | 国药准字H20247121 | 8mg(以C₈H₁₂N₂·2HCl计) | Category A (甲) | XN07CAB046A001020303098 | NHSA |
| 河南中杰药业有限公司 | 国药准字H20217112 | 8mg | Category A (甲) | XN07CAB046A001020303227 | NHSA |
| 山东力诺制药有限公司 | 国药准字H20269094 | 4mg | Category A (甲) | XN07CAB046A001020384029 | NHSA |
| 上海理想制药有限公司 | 国药准字H20265152 | 4mg | Category A (甲) | XN07CAB046A001020400698 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H50020381 | 4mg | Category A (甲) | XN07CAB046A001020401016 | NHSA |
| 河南中杰药业有限公司 | 国药准字H20217112 | 8mg | Category A (甲) | XN07CAB046A001020403227 | NHSA |
| 山东力诺制药有限公司 | 国药准字H20269094 | 4mg | Category A (甲) | XN07CAB046A001020484029 | NHSA |
| 上海理想制药有限公司 | 国药准字H20265152 | 4mg | Category A (甲) | XN07CAB046A001020500698 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H50020381 | 4mg | Category A (甲) | XN07CAB046A001020501016 | NHSA |
| 河南中杰药业有限公司 | 国药准字H20217112 | 8mg | Category A (甲) | XN07CAB046A001020503227 | NHSA |
| 上海理想制药有限公司 | 国药准字H20265152 | 4mg | Category A (甲) | XN07CAB046A001020600698 | NHSA |
| 河南中杰药业有限公司 | 国药准字H20217112 | 8mg | Category A (甲) | XN07CAB046A001020603227 | NHSA |
| 河南中杰药业有限公司 | 国药准字H20217112 | 8mg | Category A (甲) | XN07CAB046A001020703227 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H50020380 | 5mg | Category A (甲) | XN07CAB046A001030101016 | NHSA |
| 上海上药信谊药厂有限公司 | 国药准字H31022080 | 4mg | Category A (甲) | XN07CAB046A017010100818 | NHSA |
| 黑龙江深行生物医药科技有限公司 | 国药准字H23020159 | 5mg | Category A (甲) | XN07CAB046A017010103754 | NHSA |
| 上海上药信谊药厂有限公司 | 国药准字H31022080 | 4mg | Category A (甲) | XN07CAB046A017010200818 | NHSA |
| 黑龙江深行生物医药科技有限公司 | 国药准字H23020159 | 5mg | Category A (甲) | XN07CAB046A017010203754 | NHSA |
| 黑龙江深行生物医药科技有限公司 | 国药准字H23020159 | 5mg | Category A (甲) | XN07CAB046A017010303754 | NHSA |
| 广东邦民制药厂有限公司 | 国药准字H44022849 | 5mg | Category A (甲) | XN07CAB046A018010100267 | NHSA |
| 上海中西三维药业有限公司 | 国药准字H31020866 | 4mg | Category A (甲) | XN07CAB046A018010100748 | NHSA |
| 上海上药信谊药厂有限公司 | 国药准字H31022080 | 4mg | Category A (甲) | XN07CAB046A018010100818 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021801 | 4mg | Category A (甲) | XN07CAB046A018010103620 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H23023161 | 5mg | Category A (甲) | XN07CAB046A018010103748 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021801 | 4mg | Category A (甲) | XN07CAB046A018010203620 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H23023161 | 5mg | Category A (甲) | XN07CAB046A018010203748 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021801 | 4mg | Category A (甲) | XN07CAB046A018010303620 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021801 | 4mg | Category A (甲) | XN07CAB046A018010403620 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021801 | 4mg | Category A (甲) | XN07CAB046A018010503620 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021801 | 4mg | Category A (甲) | XN07CAB046A018010603620 | NHSA |
| 广东邦民制药厂有限公司 | 国药准字H44022848 | 10mg | Category A (甲) | XN07CAB046A018020100267 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021802 | 5mg | Category A (甲) | XN07CAB046A018020103620 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H23023161 | 5mg | Category A (甲) | XN07CAB046A018020103748 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021802 | 5mg | Category A (甲) | XN07CAB046A018020203620 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021802 | 5mg | Category A (甲) | XN07CAB046A018020303620 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H23023161 | 5mg | Category A (甲) | XN07CAB046A018020303748 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021802 | 5mg | Category A (甲) | XN07CAB046A018020403620 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H23023161 | 5mg | Category A (甲) | XN07CAB046A018020403748 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021802 | 5mg | Category A (甲) | XN07CAB046A018020503620 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H23023161 | 5mg | Category A (甲) | XN07CAB046A018020503748 | NHSA |
| 郑州普济堂药业有限公司 | 国药准字H23021802 | 5mg | Category A (甲) | XN07CAB046A018020603620 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H23023161 | 5mg | Category A (甲) | XN07CAB046A018020603748 | NHSA |
| 黑龙江亿达鸿药业有限公司 | 国药准字H23023161 | 5mg | Category A (甲) | XN07CAB046A018020703748 | 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: 11 filings and 6 distinct first applicants.
Generic 7 · Supplement 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 海南药谷云生物科技有限公司;海南海灵化学制药有限公司 | CYHS2602528 | Generic | 2026/10/14 | Not stated by source | CDE |
| 海南药谷云生物科技有限公司;海南海灵化学制药有限公司 | CYHS2602527 | Generic | 2026/10/14 | Not stated by source | CDE |
| 乐普恒久远药业有限公司 | CYHB2601172 | Supplement | 2026/06/23 | Not stated by source | CDE |
| 乐普恒久远药业有限公司 | CYHB2601171 | Supplement | 2026/06/23 | Not stated by source | CDE |
| 北京京丰制药集团有限公司 | CYHS2600388 | Generic | 2026/02/06 | Not stated by source | CDE |
| 北京京丰制药集团有限公司 | CYHS2600387 | Generic | 2026/02/06 | Not stated by source | CDE |
| 上海中西三维药业有限公司;上海上药中西制药有限公司 | CYHB2550416 | Supplement | 2025/12/31 | Not stated by source | CDE |
| 上海中西三维药业有限公司;上海上药中西制药有限公司 | CYHB2550415 | Supplement | 2025/12/31 | Not stated by source | CDE |
| 安徽海天信恒药业有限公司;华益药业科技(安徽)有限公司 | CYHS2503221 | Generic | 2025/09/02 | Not stated by source | CDE |
| 安徽海天信恒药业有限公司;华益药业科技(安徽)有限公司 | CYHS2503220 | Generic | 2025/09/02 | Not stated by source | CDE |
| 卡文迪许（泰州）药业有限公司;山东齐都药业有限公司 | CYHS2602608 | Generic | 2026/10/23 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 5 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 海南药谷云生物科技有限公司;海南海灵化学制药有限公司 | CYHS2602528 | Generic | 2026/10/14 | Not stated by source | CDE |
| 海南药谷云生物科技有限公司;海南海灵化学制药有限公司 | CYHS2602527 | Generic | 2026/10/14 | Not stated by source | CDE |
| 北京京丰制药集团有限公司 | CYHS2600388 | Generic | 2026/02/06 | Not stated by source | CDE |
| 北京京丰制药集团有限公司 | CYHS2600387 | Generic | 2026/02/06 | Not stated by source | CDE |
| 卡文迪许（泰州）药业有限公司;山东齐都药业有限公司 | CYHS2602608 | Generic | 2026/10/23 | 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 | Salt-normalized 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 | Salt-normalized 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 | Salt-normalized 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 | Salt-normalized ingredient | 2026/01/05 | CDE |
| 甲磺酸倍他司汀 | 河南普瑞制药有限公司 | Y20240000139 | A | Salt-normalized ingredient | 2025/07/11 | CDE |
| 甲磺酸倍他司汀 | APICHEM Laboratories Private Limited, Unit-III | Y20230000819 | A | Salt-normalized 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 | Salt-normalized ingredient | 2024/12/13 | CDE |
| 盐酸倍他司汀 | 河北国龙制药有限公司 | Y20230000179 | A | Exact ingredient | 2026/10/20 | CDE |
| 甲磺酸倍他司汀 | 河北国龙制药有限公司 | Y20220001251 | A | Salt-normalized ingredient | 2026/09/02 | CDE |
| 盐酸倍他司汀 | 兰西哈三联制药有限公司 | Y20220001031 | A | Exact ingredient | 2025/10/30 | CDE |
| 盐酸倍他司汀 | Laboratorios Espinos Y Bofill S.A.（Lebsa） | Y20200001475 | A | Exact 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 | Exact ingredient | 2025/03/04 | CDE |
| 盐酸倍他司汀 | COHANCE LIFESCIENCES LIMITED | Y20200000965 | A | Exact 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 | Exact ingredient | 2025/12/31 | CDE |
| 甲磺酸倍他司汀 | Tokuyama Corporation | Y20190009122 | A | Salt-normalized ingredient | 2024/10/29 | CDE |
| 盐酸倍他司汀 | 锦州九泰药业有限公司 | Y20190003821 | A | Exact 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 | Exact ingredient | 2025/03/04 | CDE |
| 甲磺酸倍他司汀 | 广东世信药业有限公司 | Y20190001636 | A | Salt-normalized 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 | Exact ingredient | 2026/01/01 | CDE |
| 盐酸倍他司汀 | AMI LIFESCIENCES PVT. LTD. | Y20170001070 | A | Exact ingredient | 2025/04/28 | CDE |
| 甲磺酸倍他司汀 | 厦门恩成制药有限公司 | Y20170000962 | A | Salt-normalized ingredient | 2024/04/02 | CDE |
| 盐酸倍他司汀 | 河南普瑞制药有限公司 | Y20170000885 | A | Exact ingredient | 2024/09/11 | CDE |
| 盐酸倍他司汀 | APICHEM Laboratories Private Limited | Y20170000391 | A | Exact 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.
-
2026/11/03Marketing application approved
锦州九泰药业有限责任公司
CYHS2501601 · 国药准字H20266491
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 58 ↗ -
2026/10/23Accepted
卡文迪许（泰州）药业有限公司;山东齐都药业有限公司
CYHS2602608
Fact date: 2026/10/23 · Site observation date: 2026/10/24
View source ↗ -
2026/10/14Accepted
海南药谷云生物科技有限公司;海南海灵化学制药有限公司
CYHS2602528
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗ -
2026/10/14Accepted
海南药谷云生物科技有限公司;海南海灵化学制药有限公司
CYHS2602527
Fact date: 2026/10/14 · 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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