Monthly
US$200
Billed every month
Sildenafil Citrate Oral Disintegrating Tablets(枸橼酸西地那非口崩片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 applicationNo longer listed under review: 1 applicationSupplement delivery: 1 application
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 holders33View records ↓
Under-review filings8View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers24View records ↓
API companies with A status28View records ↓
Chemical-drug catalogue
Loaded records: 33 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 32 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 |
|---|---|---|---|---|---|---|
| 西施兰（南阳）药业股份有限公司 | 西施兰（南阳）药业股份有限公司 | 国药准字H20266234 | 2026/10/13 | 50mg（按C22H30N6O4S计） | 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 |
| 上海桓华制药有限公司 | 上海桓华制药有限公司 | 国药准字H20265516 | 2026/08/04 | 50mg（按C22H30N6O4S计） | 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 |
| 河南君善生物技术有限公司 | 济南高华制药有限公司 | 国药准字H20265252 | 2026/07/21 | 50mg（按C22H30N6O4S计） | 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 |
| 南京康川济医药科技有限公司 | 九洲生物医药（台州）有限公司 | 国药准字H20264919 | 2026/06/23 | 50mg（按C22H30N6O4S计） | 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 |
| 东莞松山湖美健生物技术有限公司 | 东莞市金美济药业有限公司 | 国药准字H20264850 | 2026/06/17 | 50mg（按C22H30N6O4S计） | 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 |
| 浙江莎普爱思药业股份有限公司 | 浙江莎普爱思药业股份有限公司 | 国药准字H20264351 | 2026/05/19 | 50mg（按C22H30N6O4S计） | 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 |
| 江西金世康药业有限公司 | 济南高华制药有限公司 | 国药准字H20264026 | 2026/04/14 | 50mg（按C22H30N6O4S计） | 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 |
| 烟台鲁银药业有限公司 | 烟台鲁银药业有限公司 | 国药准字H20263909 | 2026/04/07 | 50mg（按C22H30N6O4S计） | 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 |
| 四川省通园制药集团有限公司 | 四川省旭晖制药有限公司 | 国药准字H20263292 | 2026/02/02 | 50mg（按C22H30N6O4S计） | 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 |
| 北京北陆药业股份有限公司 | 北京北陆药业股份有限公司 | 国药准字H20256390 | 2025/12/22 | 50mg（按C22H30N6O4S计） | 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 |
| 北京星昊盈盛药业有限公司 | 北京星昊盈盛药业有限公司 | 国药准字H20255794 | 2025/10/28 | 50mg(按C22H30N6O4S计) | 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 |
| 济南高华制药有限公司 | 济南高华制药有限公司 | 国药准字H20254863 | 2025/07/15 | 50mg（按C22H30N6O4S计） | Not stated by source | CDE |
| 浙江九洲生物医药有限公司 | 浙江四维医药科技有限公司 | 国药准字H20254619 | 2025/06/24 | 50mg（按C22H30N6O4S计） | 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 |
| 恒昌（广州）新药研究有限公司 | 武汉海特生物制药股份有限公司 | 国药准字H20254049 | 2025/04/30 | 50mg（按C22H30N6O4S计） | 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 |
| 金鸿药业股份有限公司 | 金鸿药业股份有限公司 | 国药准字H20249739 | 2024/12/17 | 50mg（按C22H30N6O4S计） | 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 |
| 生达化学制药股份有限公司 | 生达化学制药股份有限公司 | 国药准字HC20240009 | 2024/11/15 | 50mg(按C22H30N6O4S计) | 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 |
| 云南龙津康佑生物医药有限公司 | 昆明龙津药业股份有限公司 | 国药准字H20249294 | 2024/11/05 | 50mg（按C22H30N6O4S计） | 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 |
| 山东朗诺制药有限公司 | 山东朗诺制药有限公司 | 国药准字H20244673 | 2024/08/20 | 50mg（按C22H30N6O4S计） | 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 |
| 安徽省先锋制药有限公司 | 安徽省先锋制药有限公司 | 国药准字H20244579 | 2024/07/30 | 50mg（按C22H30N6O4S计） | 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 |
| 福州海王福药制药有限公司 | 福州海王福药制药有限公司 | 国药准字H20244332 | 2024/06/28 | 50mg（按C22H30N6O4S计） | 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 |
| 南京长澳制药有限公司 | 南京长澳制药有限公司 | 国药准字H20243930 | 2024/06/04 | 50mg（按C22H30N6O4S计） | 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 |
| 仁合益康集团有限公司 | 河北仁合益康药业有限公司 | 国药准字H20243684 | 2024/05/15 | 50mg（按C22H30N6O4S计） | 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 |
| 山东华铂凯盛生物科技有限公司 | 安徽泰恩康制药有限公司 | 国药准字H20243695 | 2024/05/15 | 50mg（按C22H30N6O4S计） | 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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20234459 | 2023/10/30 | 50mg（按C22H30N6O4S计） | 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 |
| 浙江佰奥医药科技有限公司 | 浙江北生药业汉生制药有限公司 | 国药准字H20234444 | 2023/10/27 | 50mg（按C22H30N6O4S计） | 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 |
| 上海金城素智药业有限公司 | 山西同达药业有限公司 | 国药准字H20234297 | 2023/10/18 | 50mg（按C22H30N6O4S计） | 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 |
| 青岛黄海制药有限责任公司 | 安徽泰恩康制药有限公司 | 国药准字H20234296 | 2023/10/18 | 50mg（按C22H30N6O4S计） | 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 |
| 景时（杭州）药业有限公司 | 浙江京新药业股份有限公司 | 国药准字H20234251 | 2023/09/28 | 50mg（按C22H30N6O4S计） | 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 |
| 江西施美药业股份有限公司 | 江西施美药业股份有限公司 | 国药准字H20233803 | 2023/06/27 | 50mg（按C22H30N6O4S计） | 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 |
| 中润药业有限公司 | 华益药业科技（安徽）有限公司 | 国药准字H20233669 | 2023/06/07 | 50mg（按C22H30N6O4S计） | 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 |
| 四川科伦药业股份有限公司 | 四川科伦药业股份有限公司 | 国药准字H20223255 | 2022/04/27 | 50mg（按C22H30N6O4S计） | 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 |
| 山东新华制药股份有限公司 | 新华制药（高密）有限公司 | 国药准字H20255352 | 2025/09/09 | 50mg（按C22H30N6O4S计） | 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 |
| 天地恒一制药股份有限公司 | 天地恒一制药股份有限公司 | 国药准字H20234567 | 2023/11/28 | 50mg（按C22H30N6O4S计） | 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 |
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: 24 distinct approval numbers and 24 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京北陆药业股份有限公司 | 国药准字H20256390 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010100014 | NHSA |
| 金鸿药业股份有限公司 | 国药准字H20249739 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010100591 | NHSA |
| 南京长澳制药有限公司 | 国药准字H20243930 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010101555 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010102180 | NHSA |
| 四川省通园制药集团有限公司 | 国药准字H20263292 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010102237 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233877 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010102766 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20234459 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010104021 | NHSA |
| 青岛黄海制药有限责任公司 | 国药准字H20234296 | 50mg(按C22H30N6O4S计) | Not stated by source | XG04BEX006A022010104043 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255352 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010104187 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20244579 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010104339 | NHSA |
| 浙江佰奥医药科技有限公司 | 国药准字H20234444 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010104610 | NHSA |
| 景时(杭州)药业有限公司 | 国药准字H20234251 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010104658 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20233803 | 50mg( 按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010105356 | NHSA |
| 江西汇仁药业股份有限公司 | 国药准字H20244673 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010110323 | NHSA |
| Upjohn EESV | H20190071 | 50mg(按C22H30N6O4S计) | Not stated by source | XG04BEX006A022010178724 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010180086 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20243684 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010183033 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010183034 | NHSA |
| 恒昌(广州)新药研究有限公司 | 国药准字H20254049 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010183569 | NHSA |
| 北京星昊盈盛药业有限公司 | 国药准字H20255794 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010184005 | NHSA |
| 浙江九洲生物医药有限公司 | 国药准字H20254619 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010184212 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249294 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010184548 | NHSA |
| 中润药业有限公司 | 国药准字H20233669 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010184795 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010185352 | NHSA |
| 金鸿药业股份有限公司 | 国药准字H20249739 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010200591 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010202180 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233877 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010202766 | NHSA |
| 青岛黄海制药有限责任公司 | 国药准字H20234296 | 50mg(按C22H30N6O4S计) | Not stated by source | XG04BEX006A022010204043 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20255352 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010204187 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20244579 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010204339 | NHSA |
| 景时(杭州)药业有限公司 | 国药准字H20234251 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010204658 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20233803 | 50mg( 按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010205356 | NHSA |
| 江西汇仁药业股份有限公司 | 国药准字H20244673 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010210323 | NHSA |
| Upjohn EESV | H20190071 | 50mg(按C22H30N6O4S计) | Not stated by source | XG04BEX006A022010278724 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010280086 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20243684 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010283033 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010283034 | NHSA |
| 恒昌(广州)新药研究有限公司 | 国药准字H20254049 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010283569 | NHSA |
| 北京星昊盈盛药业有限公司 | 国药准字H20255794 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010284005 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249294 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010284548 | NHSA |
| 中润药业有限公司 | 国药准字H20233669 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010284795 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010285352 | NHSA |
| 金鸿药业股份有限公司 | 国药准字H20249739 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010300591 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010302180 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233877 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010302766 | NHSA |
| 青岛黄海制药有限责任公司 | 国药准字H20234296 | 50mg(按C22H30N6O4S计) | Not stated by source | XG04BEX006A022010304043 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20244579 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010304339 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20233803 | 50mg( 按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010305356 | NHSA |
| 江西汇仁药业股份有限公司 | 国药准字H20244673 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010310323 | NHSA |
| Upjohn EESV | H20190071 | 50mg(按C22H30N6O4S计) | Not stated by source | XG04BEX006A022010378724 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010380086 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20243684 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010383033 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010383034 | NHSA |
| 恒昌(广州)新药研究有限公司 | 国药准字H20254049 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010383569 | NHSA |
| 北京星昊盈盛药业有限公司 | 国药准字H20255794 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010384005 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249294 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010384548 | NHSA |
| 中润药业有限公司 | 国药准字H20233669 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010384795 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010385352 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010402180 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233877 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010402766 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20244579 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010404339 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20233803 | 50mg( 按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010405356 | NHSA |
| 江西汇仁药业股份有限公司 | 国药准字H20244673 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010410323 | NHSA |
| Upjohn EESV | H20190071 | 50mg(按C22H30N6O4S计) | Not stated by source | XG04BEX006A022010478724 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010480086 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20243684 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010483033 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010483034 | NHSA |
| 恒昌(广州)新药研究有限公司 | 国药准字H20254049 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010483569 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249294 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010484548 | NHSA |
| 中润药业有限公司 | 国药准字H20233669 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010484795 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010485352 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010502180 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233877 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010502766 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20233803 | 50mg( 按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010505356 | NHSA |
| 江西汇仁药业股份有限公司 | 国药准字H20244673 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010510323 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010580086 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20243684 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010583033 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010583034 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249294 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010584548 | NHSA |
| 中润药业有限公司 | 国药准字H20233669 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010584795 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010585352 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010602180 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233877 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010602766 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20233803 | 50mg( 按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010605356 | NHSA |
| 江西汇仁药业股份有限公司 | 国药准字H20244673 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010610323 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010680086 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20243684 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010683033 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010683034 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249294 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010684548 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010685352 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233877 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010702766 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20233803 | 50mg( 按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010705356 | NHSA |
| 江西汇仁药业股份有限公司 | 国药准字H20244673 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010710323 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010780086 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20243684 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010783033 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010783034 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249294 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010784548 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010785352 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233877 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010802766 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010880086 | NHSA |
| 仁合益康集团有限公司 | 国药准字H20243684 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010883033 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010883034 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249294 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010884548 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010885352 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233877 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010902766 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010980086 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022010983034 | NHSA |
| 河北龙海药业股份有限公司 | 国药准字H20233877 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011002766 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011083034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011183034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011283034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011383034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011483034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011583034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011683034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011783034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011883034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022011983034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022012083034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022012183034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022012283034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022012383034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022012483034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022012583034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022012683034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022012783034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022012883034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022012983034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022013083034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022013183034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022013283034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022013383034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022013483034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022013583034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022013683034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022013783034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022013883034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022013983034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022014083034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022014183034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022014283034 | NHSA |
| 山东华铂凯盛生物科技有限公司 | 国药准字H20243695 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022014383034 | NHSA |
| 金鸿药业股份有限公司 | 国药准字H20249739 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020100591 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020102180 | NHSA |
| 浙江佰奥医药科技有限公司 | 国药准字H20234444 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020104610 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20233803 | 50mg( 按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020105356 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020180086 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020185352 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020202180 | NHSA |
| 浙江佰奥医药科技有限公司 | 国药准字H20234444 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020204610 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020285352 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020302180 | NHSA |
| 浙江佰奥医药科技有限公司 | 国药准字H20234444 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020304610 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020385352 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020402180 | NHSA |
| 浙江佰奥医药科技有限公司 | 国药准字H20234444 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020404610 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020485352 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20223255 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020502180 | NHSA |
| 浙江佰奥医药科技有限公司 | 国药准字H20234444 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020504610 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020585352 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020685352 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020785352 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020885352 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022020985352 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022021085352 | NHSA |
| 济南高华制药有限公司 | 国药准字H20254863 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022021185352 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022030180086 | NHSA |
| 湖北福瑞龙药业有限公司 | 国药准字H20234567 | 50mg(按C₂₂H₃₀N₆O₄S计) | Not stated by source | XG04BEX006A022040180086 | 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: 8 filings and 8 distinct first applicants.
Generic 8
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 华泰民康（沈阳）科技有限公司;苏州特瑞药业股份有限公司 | CYHS2600476 | Generic | 2026/02/14 | Not stated by source | CDE |
| 常州康普药业有限公司 | CYHS2504282 | Generic | 2025/12/13 | Not stated by source | CDE |
| 广州琥瑞医药科技发展有限公司;珠海润都制药股份有限公司 | CYHS2602376 | Generic | 2026/09/21 | Not stated by source | CDE |
| 湖北菲瑞生物药业有限公司 | CYHS2601149 | Generic | 2026/05/14 | Not stated by source | CDE |
| 山东创新药物研发有限公司;江西施美药业股份有限公司 | CYHS2600883 | Generic | 2026/04/17 | Not stated by source | CDE |
| 湖北午时药业股份有限公司 | CYHS2600283 | Generic | 2026/01/27 | Not stated by source | CDE |
| 正大天晴药业集团股份有限公司 | CYHS2503948 | Generic | 2025/11/13 | Not stated by source | CDE |
| 津华医药科技（湖州）有限公司;河北龙海药业股份有限公司 | CYHS2502601 | Generic | 2025/07/18 | 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 |
|---|---|---|---|---|---|
| 华泰民康（沈阳）科技有限公司;苏州特瑞药业股份有限公司 | CYHS2600476 | Generic | 2026/02/14 | Not stated by source | CDE |
| 广州琥瑞医药科技发展有限公司;珠海润都制药股份有限公司 | CYHS2602376 | Generic | 2026/09/21 | Not stated by source | CDE |
| 湖北菲瑞生物药业有限公司 | CYHS2601149 | Generic | 2026/05/14 | Not stated by source | CDE |
| 山东创新药物研发有限公司;江西施美药业股份有限公司 | CYHS2600883 | Generic | 2026/04/17 | Not stated by source | CDE |
| 湖北午时药业股份有限公司 | CYHS2600283 | Generic | 2026/01/27 | Not stated by source | CDE |
API registrations
Non-component matches: 28 companies with A status and 9 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 |
|---|---|---|---|---|---|---|
| 枸橼酸西地那非 | Upjohn EESV | Y20260000283 | I | Exact ingredient | 2026/07/16 | CDE |
| 枸橼酸西地那非 | Smilax Laboratories Limited | Y20250000574 | I | Exact ingredient | 2025/09/17 | CDE |
| 枸橼酸西地那非 | 上海汇伦江苏药业有限公司 | Y20240000285 | A | Exact ingredient | 2025/07/31 | CDE |
| 枸橼酸西地那非 | Haleos Labs Limited, Unit 1 | Y20230000237 | A | Exact ingredient | 2026/05/20 | CDE |
| 枸橼酸西地那非 | SMS Pharmaceuticals Limited | Y20220000208 | A | Exact ingredient | 2026/10/31 | CDE |
| 枸橼酸西地那非 | 广州白云山医药集团股份有限公司白云山化学制药厂 | Y20220000281 | A | Exact ingredient | 2025/02/25 | CDE |
| 枸橼酸西地那非 | 遂成药业股份有限公司 | Y20220000424 | A | Exact ingredient | 2024/12/31 | CDE |
| 枸橼酸西地那非 | 河北安健成益医药科技有限公司 | Y20220000007 | A | Exact ingredient | 2024/03/19 | CDE |
| 枸橼酸西地那非 | Upjohn EESV | Y20210000693 | I | Exact ingredient | 2024/07/23 | CDE |
| 枸橼酸西地那非 | 重庆康刻尔制药股份有限公司 | Y20210000463 | A | Exact ingredient | 2023/08/29 | CDE |
| 枸橼酸西地那非 | Raks Pharma Pvt. Ltd. | Y20210000303 | I | Exact ingredient | 2021/07/07 | CDE |
| 枸橼酸西地那非 | 新乡制药股份有限公司 | Y20210000286 | A | Exact ingredient | 2026/03/10 | CDE |
| 枸橼酸西地那非 | Apitoria Pharma Private Limited | Y20200001254 | A | Exact ingredient | 2026/02/14 | CDE |
| 枸橼酸西地那非 | 迪嘉药业集团股份有限公司 | Y20200001215 | A | Exact ingredient | 2026/09/27 | CDE |
| 枸橼酸西地那非 | Azico Biophore India Pvt.Ltd. | Y20200001203 | A | Exact ingredient | 2025/06/15 | CDE |
| 枸橼酸西地那非 | 四川科伦药业股份有限公司 | Y20190021415 | A | Exact ingredient | 2024/01/26 | CDE |
| 枸橼酸西地那非 | Hetero Drugs Limited | Y20190000581 | A | Exact ingredient | 2025/12/06 | CDE |
| 枸橼酸西地那非 | Pfizer Inc. | Y20190009929 | A | Exact ingredient | 2023/03/24 | CDE |
| 枸橼酸西地那非 | 广州白云山医药集团股份有限公司白云山化学制药厂 | Y20190009908 | A | Exact ingredient | 2024/07/11 | CDE |
| 枸橼酸西地那非 | 河北常山生化药业股份有限公司 | Y20190009794 | A | Exact ingredient | — | CDE |
| 枸橼酸西地那非 | 常州亚邦制药有限公司 | Y20190009373 | A | Exact ingredient | 2024/10/23 | CDE |
| 枸橼酸西地那非 | 四川源基制药有限公司 | Y20190008890 | A | Exact ingredient | 2023/03/24 | CDE |
| 枸橼酸西地那非 | 齐鲁制药有限公司 | Y20190006703 | A | Exact ingredient | 2026/07/24 | CDE |
| 枸橼酸西地那非 | 常州亚邦制药有限公司 | Y20180001257 | I | Exact ingredient | 2023/03/24 | CDE |
| 枸橼酸西地那非 | MSN Organics Private Limited | Y20180001023 | A | Exact ingredient | 2026/06/09 | CDE |
| 枸橼酸西地那非 | 河北常山生化药业股份有限公司 | Y20180001559 | A | Exact ingredient | 2026/05/20 | CDE |
| 枸橼酸西地那非 | 广州白云山医药集团股份有限公司白云山化学制药厂 | Y20180001073 | I | Exact ingredient | 2018/09/29 | CDE |
| 枸橼酸西地那非 | Upjohn EESV | Y20170002198 | A | Exact ingredient | 2025/08/01 | CDE |
| 枸橼酸西地那非 | 吉林金恒制药股份有限公司 | Y20170002066 | A | Exact ingredient | 2025/01/04 | CDE |
| 枸橼酸西地那非 | Upjohn EESV | Y20170001942 | A | Exact ingredient | 2025/08/01 | CDE |
| 枸橼酸西地那非 | 浙江九洲药物科技有限公司 | Y20170001329 | A | Exact ingredient | 2024/09/27 | CDE |
| 枸橼酸西地那非 | 福建广生堂药业股份有限公司 | Y20170001223 | A | Exact ingredient | 2022/09/30 | CDE |
| 枸橼酸西地那非 | 济南明鑫制药股份有限公司 | Y20170001189 | A | Exact ingredient | 2024/04/16 | CDE |
| 枸橼酸西地那非 | Y20170000881 | I | Exact ingredient | — | CDE | |
| 枸橼酸西地那非 | 瑞阳制药股份有限公司 | Y20170000859 | A | Exact ingredient | 2024/03/01 | CDE |
| 枸橼酸西地那非 | 重庆圣华曦药业股份有限公司 | Y20170000777 | A | Exact ingredient | 2024/08/07 | CDE |
| 枸橼酸西地那非 | 乐普药业股份有限公司 | Y20170000614 | I | Exact ingredient | — | CDE |
| 枸橼酸西地那非 | Pharmaceutical Works Polpharma S.A. | Y20170000462 | A | Exact ingredient | 2025/10/24 | CDE |
| 枸橼酸西地那非 | Assia Chemical Industries Ltd. | Y20170000393 | A | Exact ingredient | 2025/05/29 | CDE |
| 枸橼酸西地那非 | 山东罗欣药业集团股份有限公司 | Y20170000357 | 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/10/23No longer listed under review
恒昌（广州）新药研究有限公司;武汉海特生物制药股份有限公司
CYHB2601448
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/07/28
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/23 (approval no.: —; approval date: 2026/10/21); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 18
NMPA · Table row 18 ↗ View source ↗ -
2026/10/21Supplement delivery
恒昌（广州）新药研究有限公司
CYHB2601448
Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 18 ↗ -
2026/09/21Accepted
广州琥瑞医药科技发展有限公司;珠海润都制药股份有限公司
CYHS2602376
Fact date: 2026/09/21 · 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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