Monthly
US$200
Billed every month
Vardenafil Hydrochloride Tablets(盐酸伐地那非片)
Companies, stages and changes, with each record available on this page.
Last 90 days: No longer listed under review: 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 holders15View records ↓
Under-review filings4View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers16View records ↓
API companies with A status9View records ↓
Chemical-drug catalogue
Loaded records: 15 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 14 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 |
|---|---|---|---|---|---|---|
| 浙江诺得药业有限公司 | 浙江诺得药业有限公司 | 国药准字H20265478 | 2026/08/04 | 10mg（按C23H32N6O4S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H20264800 | 2026/06/17 | 10mg（按C23H32N6O4S 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H20264799 | 2026/06/17 | 20mg（按C23H32N6O4S 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 |
| 浙江诺得药业有限公司 | 浙江诺得药业有限公司 | 国药准字H20263715 | 2026/03/25 | 20mg（按C23H32N6O4S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 |
| 江西汇仁药业股份有限公司 | 江西汇仁药业股份有限公司 | 国药准字H20256414 | 2025/12/30 | 20mg（按C23H32N6O4S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 |
| 江西汇仁药业股份有限公司 | 江西汇仁药业股份有限公司 | 国药准字H20256415 | 2025/12/30 | 10mg（按C23H32N6O4S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 |
| 山东鲁抗医药集团赛特有限责任公司 | 安徽泰恩康制药有限公司 | 国药准字H20254953 | 2025/07/29 | 20mg（按C23H32N6O4S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 |
| 广州绿十字制药股份有限公司 | 广州绿十字制药股份有限公司 | 国药准字H20254173 | 2025/05/13 | 20mg（按C23H32N6O4S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 |
| 江苏万高药业股份有限公司 | 江苏万高药业股份有限公司 | 国药准字H20254130 | 2025/05/13 | 20mg （按C23H32N6O4S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 |
| 江苏万高药业股份有限公司 | 江苏万高药业股份有限公司 | 国药准字H20254129 | 2025/05/13 | 10mg （按C23H32N6O4S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 |
| 山东海雅医药科技有限公司 | 南京海纳制药有限公司 | 国药准字H20249572 | 2024/12/01 | 20mg（按C<sub>23</sub>H<sub>32</sub>N<sub>6</sub>O<sub>4</sub>S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 |
| 国药控股星鲨制药（厦门）有限公司 | 国药控股星鲨制药（厦门）有限公司 | 国药准字H20249431 | 2024/11/22 | 20mg（按C23H32N6O4S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 |
| 浙江施强制药有限公司 | 浙江施强制药有限公司 | 国药准字H20249029 | 2024/10/09 | 20mg（按C23H32N6O4S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H20244792 | 2024/09/03 | 20mg（按C23H32N6O4S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 |
| 海南红祥旗荣医药科技有限公司 | 山东朗诺制药有限公司 | 国药准字H20243123 | 2024/01/30 | 20mg（按C23H32N6O4S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 |
| 海南红祥旗荣医药科技有限公司 | 山东朗诺制药有限公司 | 国药准字H20243124 | 2024/01/30 | 10mg（按C23H32N6O4S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 |
| 扬子江药业集团有限公司 | 扬子江药业集团有限公司 | 国药准字H20233768 | 2023/06/21 | 20mg（按C23H32N6O4S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 |
| 广西强寿药业集团有限公司 | 广西强寿药业集团有限公司 | 国药准字H20233690 | 2023/06/07 | 20mg（按C23H32N6O4S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H20203339 | 2020/07/21 | 20mg（按C23H32N6O4S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H20203338 | 2020/07/21 | 10mg（按C23H32N6O4S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 |
| Bayer AG | Bayer AG | H20140495;H20140497 | 2004/08/05 | 20mg | Imported originator drug (进口原研药品) | 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: 16 distinct approval numbers and 12 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 广州绿十字制药股份有限公司 | 国药准字H20254173 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010100475 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010101503 | NHSA |
| 扬子江药业集团有限公司 | 国药准字H20233768 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010101749 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203338 | 10mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001010102180 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20254953 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010104131 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20244792 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010104339 | NHSA |
| 浙江施强制药有限公司 | 国药准字H20249029 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010104578 | NHSA |
| 国药控股星鲨制药(厦门)有限公司 | 国药准字H20249431 | 20mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001010104873 | NHSA |
| 广西强寿药业集团有限公司 | 国药准字H20233690 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010105134 | NHSA |
| 山东海雅医药科技有限公司 | 国药准字H20249572 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010183087 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010183521 | NHSA |
| 海南红祥旗荣医药科技有限公司 | 国药准字H20243123 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010183946 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010201503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203338 | 10mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001010202180 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20254953 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010204131 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20244792 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010204339 | NHSA |
| 广西强寿药业集团有限公司 | 国药准字H20233690 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010205134 | NHSA |
| 山东海雅医药科技有限公司 | 国药准字H20249572 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010283087 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010283521 | NHSA |
| 海南红祥旗荣医药科技有限公司 | 国药准字H20243123 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010283946 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010301503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203338 | 10mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001010302180 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20244792 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010304339 | NHSA |
| 山东海雅医药科技有限公司 | 国药准字H20249572 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010383087 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010383521 | NHSA |
| 海南红祥旗荣医药科技有限公司 | 国药准字H20243123 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010383946 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010401503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203338 | 10mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001010402180 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20244792 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010404339 | NHSA |
| 山东海雅医药科技有限公司 | 国药准字H20249572 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010483087 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010483521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010501503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203338 | 10mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001010502180 | NHSA |
| 安徽省先锋制药有限公司 | 国药准字H20244792 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010504339 | NHSA |
| 山东海雅医药科技有限公司 | 国药准字H20249572 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010583087 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010583521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010601503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203338 | 10mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001010602180 | NHSA |
| 山东海雅医药科技有限公司 | 国药准字H20249572 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010683087 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010683521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010701503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203338 | 10mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001010702180 | NHSA |
| 山东海雅医药科技有限公司 | 国药准字H20249572 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010783087 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010783521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010801503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203338 | 10mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001010802180 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010883521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010901503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203338 | 10mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001010902180 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001010983521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011001503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203338 | 10mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001011002180 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011083521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011101503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011183521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011201503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011283521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011301503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011383521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011401503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011483521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011501503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011583521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254130 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011601503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011683521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011783521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011883521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001011983521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001012083521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001012183521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001012283521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001012383521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001012483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001012583521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001012683521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001012783521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001012883521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001012983521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001013083521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001013183521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001013283521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001013383521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001013483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20263715 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001013583521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020101503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203339 | 20mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001020102180 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20254953 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020104131 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020183521 | NHSA |
| 海南红祥旗荣医药科技有限公司 | 国药准字H20243124 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020183946 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020201503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203339 | 20mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001020202180 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020283521 | NHSA |
| 海南红祥旗荣医药科技有限公司 | 国药准字H20243124 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020283946 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020301503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203339 | 20mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001020302180 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020383521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020401503 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20203339 | 20mg(按C23H32N6O4S计) | Not stated by source | XG04BEF001A001020402180 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020483521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020501503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020583521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020601503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020683521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020701503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020783521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020801503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020883521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020901503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001020983521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021001503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021083521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021101503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021183521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021201503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021283521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021301503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021383521 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254129 | 10mg (按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021401503 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021583521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021683521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021783521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021883521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001021983521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001022083521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001022183521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001022283521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001022383521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001022483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001022583521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001022683521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001022783521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001022883521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001022983521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001023083521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001023183521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001023283521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001023383521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001023483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001023583521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001023683521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001023783521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001023883521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001023983521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001024083521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001024183521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001024283521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001024383521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001024483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20265478 | 10mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001024583521 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20254953 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001030104131 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20254953 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001040104131 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20254953 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001050104131 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20254953 | 20mg(按C₂₃H₃₂N₆O₄S计) | Not stated by source | XG04BEF001A001060104131 | 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: 4 filings and 3 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 杭州民生药物研究院有限公司;江苏万高药业股份有限公司 | CYHS2502733 | Generic | 2025/07/30 | Not stated by source | CDE |
| 保定天浩制药有限公司;杨凌步长制药有限公司 | CYHS2601846 | Generic | 2026/07/31 | Not stated by source | CDE |
| 保定天浩制药有限公司;杨凌步长制药有限公司 | CYHS2601845 | Generic | 2026/07/31 | Not stated by source | CDE |
| 浙江英格莱制药有限公司 | CYHS2600690 | Generic | 2026/03/21 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 保定天浩制药有限公司;杨凌步长制药有限公司 | CYHS2601846 | Generic | 2026/07/31 | Not stated by source | CDE |
| 保定天浩制药有限公司;杨凌步长制药有限公司 | CYHS2601845 | Generic | 2026/07/31 | Not stated by source | CDE |
| 浙江英格莱制药有限公司 | CYHS2600690 | Generic | 2026/03/21 | Not stated by source | CDE |
API registrations
Non-component matches: 9 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 |
|---|---|---|---|---|---|---|
| 盐酸伐地那非 | 山东济坤生物制药有限公司 | Y20250000708 | I | Exact ingredient | 2025/07/16 | CDE |
| 盐酸伐地那非 | 上海合全药业股份有限公司 | Y20230001158 | A | Exact ingredient | 2025/07/29 | CDE |
| 盐酸伐地那非 | 杨凌吉泰药业有限公司 | Y20230000021 | A | Exact ingredient | 2024/10/17 | CDE |
| 盐酸伐地那非 | Alembic Pharmaceuticals Limited | Y20210000075 | A | Exact ingredient | 2024/06/28 | CDE |
| 盐酸伐地那非 | 常州制药厂有限公司 | Y20210000746 | A | Exact ingredient | 2023/09/27 | CDE |
| 盐酸伐地那非 | 广西强寿药业集团有限公司 | Y20210000500 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸伐地那非 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20210000036 | A | Exact ingredient | 2025/01/11 | CDE |
| 盐酸伐地那非 | 金鸿药业股份有限公司,金鸿药业股份有限公司 | Y20200001095 | A | Exact ingredient | 2024/04/19 | CDE |
| 盐酸伐地那非 | 山东朗诺制药有限公司 | Y20180001528 | A | Exact ingredient | 2024/02/07 | CDE |
| 盐酸伐地那非三水合物 | 四川科伦药业股份有限公司 | Y20180000752 | A | Salt-normalized ingredient | 2025/04/23 | CDE |
| 盐酸伐地那非三水合物 | Pharmaceutical Works POLPHARMA S.A. | Y20170001262 | I | Salt-normalized 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.
-
2026/11/07No longer listed under review
江西施美药业股份有限公司
CYHS2501279
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2025/04/03
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/11/07No longer listed under review
江西施美药业股份有限公司
CYHS2501278
Fact date: 2026/11/07 · Site observation date: 2026/11/07
Accepted: 2025/04/03
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/27No longer listed under review
山东百诺医药股份有限公司;山东明仁福瑞达制药股份有限公司
CYHS2501726
Fact date: 2026/10/27 · Site observation date: 2026/10/27
Accepted: 2025/05/14
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
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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