Monthly
US$200
Billed every month
Nifedipine Controlled-release Tablets(硝苯地平控释片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 4 applicationsSupplement 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 holders28View records ↓
Under-review filings8View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers34View records ↓
API companies with A status35View records ↓
Chemical-drug catalogue
Loaded records: 28 holders; 2 in the quality-and-efficacy consistency-evaluation category, and 22 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 |
|---|---|---|---|---|---|---|
| 天津力生制药股份有限公司 | 天津力生制药股份有限公司 | 国药准字H20265115 | 2026/07/08 | 30mg | 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 |
| 复星医药（徐州）有限公司 | 复星医药（徐州）有限公司 | 国药准字H20255231 | 2025/08/26 | 30mg | 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 |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20249648 | 2024/12/01 | 30mg | 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 | 青岛黄海生物制药有限责任公司 | 国药准字H20249162 | 2024/10/22 | 30mg | 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 |
| 山西双雁药业有限公司 | 山西双雁药业有限公司 | 国药准字H20244499 | 2024/07/30 | 60mg | Not stated by source | CDE |
| 山西双雁药业有限公司 | 山西双雁药业有限公司 | 国药准字H20244498 | 2024/07/30 | 30mg | Not stated by source | CDE |
| 亚宝药业集团股份有限公司 | 亚宝药业集团股份有限公司 | 国药准字H20244594 | 2024/07/30 | 30mg | 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 |
| 江西山香药业有限公司 | 江西山香药业有限公司 | 国药准字H20243688 | 2024/05/15 | 30mg | 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 |
| 锦州奥鸿药业有限责任公司 | 合肥立方制药股份有限公司 | 国药准字H20234668 | 2023/12/19 | 30mg | 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 |
| 山西同达药业有限公司 | 山西同达药业有限公司 | 国药准字H20234580 | 2023/12/05 | 60mg | 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 |
| 南京星银药业集团有限公司 | 南京星银药业集团有限公司 | 国药准字H20234610 | 2023/12/05 | 30mg | Not stated by source | CDE |
| 广州玻思韬控释药业有限公司 | 广州玻思韬控释药业有限公司 | 国药准字H20234615 | 2023/12/05 | 30mg | Not stated by source | CDE |
| 乐普药业股份有限公司 | 乐普药业股份有限公司 | 国药准字H20234506 | 2023/11/21 | 30mg | 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H20234525 | 2023/11/21 | 30mg | 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 |
| 合肥华方医药科技有限公司 | 合肥思普瑞药业有限公司 | 国药准字H20234152 | 2023/09/12 | 30mg | 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 |
| 德州德药制药有限公司 | 德州德药制药有限公司 | 国药准字H20233735 | 2023/06/14 | 30mg | 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 |
| 浙江华海药业股份有限公司 | 浙江华海药业股份有限公司 | 国药准字H20233647 | 2023/06/07 | 30mg | 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 |
| 华润双鹤利民药业（济南）有限公司 | 华润双鹤利民药业（济南）有限公司 | 国药准字H20223465 | 2022/06/30 | 30mg | 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 |
| 广州九瑞药业有限公司 | 淄博万杰制药有限公司 | 国药准字H20223413 | 2022/06/16 | 30mg | 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 |
| 石药集团欧意药业有限公司 | 石药集团欧意药业有限公司 | 国药准字H20223238 | 2022/04/19 | 30mg | 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H20223165 | 2022/03/22 | 30mg | 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 |
| 上海现代制药股份有限公司 | 上海现代制药股份有限公司 | 国药准字H20000079 | 2022/02/16 | 30mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 广州一品红制药有限公司 | 广州一品红制药有限公司 | 国药准字H20223060 | 2022/01/30 | 60mg | 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 |
| 广州一品红制药有限公司 | 广州一品红制药有限公司 | 国药准字H20223061 | 2022/01/30 | 30mg | 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 |
| 合肥立方制药股份有限公司 | 合肥立方制药股份有限公司 | 国药准字H20213898 | 2021/11/24 | 30mg | 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 |
| 北京红林制药有限公司 | 北京红林制药有限公司 | 国药准字H20103238 | 2021/04/30 | 30mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 青岛百洋制药有限公司 | 青岛百洋制药有限公司 | 国药准字H20213315 | 2021/04/27 | 30mg | 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 |
| 海南先声药业有限公司 | 海南先声药业有限公司 | 国药准字H20213314 | 2021/04/27 | 30mg | 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 |
| 南京易亨制药有限公司 | 南京易亨制药有限公司 | 国药准字H20203375 | 2020/07/29 | 30mg | 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 Pharma AG | Bayer Pharma AG | H20130332 | 1994/11/02 | 30mg | Imported originator drug (进口原研药品) | CDE |
| Bayer Pharma AG | Bayer Pharma AG | H20130334 | 1994/11/02 | 60mg | 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: 34 distinct approval numbers and 29 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Bayer AG | 国药准字J20180025 | 30mg | Category A (甲) | XC08CAX066A011010100002 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011010100044 | NHSA |
| 上海现代制药股份有限公司 | 国药准字H20000079 | 30mg | Category A (甲) | XC08CAX066A011010100785 | NHSA |
| 天津力生制药股份有限公司 | 国药准字H20265115 | 30mg | Category A (甲) | XC08CAX066A011010100886 | NHSA |
| 广州一品红制药有限公司 | 国药准字H20223061 | 30mg | Category A (甲) | XC08CAX066A011010101012 | NHSA |
| 锦州奥鸿药业有限责任公司 | 国药准字H20234668 | 30mg | Category A (甲) | XC08CAX066A011010101190 | NHSA |
| 常州制药厂有限公司 | 国药准字H20233478 | 30mg | Category A (甲) | XC08CAX066A011010101397 | NHSA |
| 南京易亨制药有限公司 | 国药准字H20203375 | 30mg | Category A (甲) | XC08CAX066A011010101605 | NHSA |
| 扬子江药业集团有限公司 | 国药准字H20223165 | 30mg | Category A (甲) | XC08CAX066A011010101749 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011010102770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011010102851 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20244594 | 30mg | Category A (甲) | XC08CAX066A011010102959 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20234506 | 30mg | Category A (甲) | XC08CAX066A011010103094 | NHSA |
| 德州德药制药有限公司 | 国药准字H20233735 | 30mg | Category A (甲) | XC08CAX066A011010103942 | NHSA |
| 华润双鹤利民药业(济南)有限公司 | 国药准字H20223465 | 30mg | Category A (甲) | XC08CAX066A011010103973 | NHSA |
| 青岛百洋制药有限公司 | 国药准字H20213315 | 30mg | Category A (甲) | XC08CAX066A011010104023 | NHSA |
| 青岛黄海制药有限责任公司 | 国药准字H20249162 | 30mg | Category A (甲) | XC08CAX066A011010104043 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011010104175 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249648 | 30mg | Category A (甲) | XC08CAX066A011010104188 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011010104240 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011010104394 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20233647 | 30mg | Category A (甲) | XC08CAX066A011010104647 | NHSA |
| 江西山香药业有限公司 | 国药准字H20243688 | 30mg | Category A (甲) | XC08CAX066A011010105345 | NHSA |
| 海南先声药业有限公司 | 国药准字H20213314 | 30mg | Category A (甲) | XC08CAX066A011010105849 | NHSA |
| 山西同达药业有限公司 | 国药准字H20234580 | 60mg | Category A (甲) | XC08CAX066A011010106183 | NHSA |
| Bayer AG | H20171341 | 30mg | Category A (甲) | XC08CAX066A011010178269 | NHSA |
| 湖南润兴药业有限公司 | 国药准字H20234615 | 30mg | Category A (甲) | XC08CAX066A011010181227 | NHSA |
| 合肥华方医药科技有限公司 | 国药准字H20234152 | 30mg | Category A (甲) | XC08CAX066A011010182856 | NHSA |
| 复星医药(徐州)有限公司 | 国药准字H20255231 | 30mg | Category A (甲) | XC08CAX066A011010185458 | NHSA |
| Bayer AG | 国药准字J20180025 | 30mg | Category A (甲) | XC08CAX066A011010200002 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011010200044 | NHSA |
| 上海现代制药股份有限公司 | 国药准字H20000079 | 30mg | Category A (甲) | XC08CAX066A011010200785 | NHSA |
| 天津力生制药股份有限公司 | 国药准字H20265115 | 30mg | Category A (甲) | XC08CAX066A011010200886 | NHSA |
| 广州一品红制药有限公司 | 国药准字H20223061 | 30mg | Category A (甲) | XC08CAX066A011010201012 | NHSA |
| 常州制药厂有限公司 | 国药准字H20233478 | 30mg | Category A (甲) | XC08CAX066A011010201397 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011010202770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011010202851 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20244594 | 30mg | Category A (甲) | XC08CAX066A011010202959 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20234506 | 30mg | Category A (甲) | XC08CAX066A011010203094 | NHSA |
| 德州德药制药有限公司 | 国药准字H20233735 | 30mg | Category A (甲) | XC08CAX066A011010203942 | NHSA |
| 华润双鹤利民药业(济南)有限公司 | 国药准字H20223465 | 30mg | Category A (甲) | XC08CAX066A011010203973 | NHSA |
| 青岛百洋制药有限公司 | 国药准字H20213315 | 30mg | Category A (甲) | XC08CAX066A011010204023 | NHSA |
| 青岛黄海制药有限责任公司 | 国药准字H20249162 | 30mg | Category A (甲) | XC08CAX066A011010204043 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011010204175 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249648 | 30mg | Category A (甲) | XC08CAX066A011010204188 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011010204240 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011010204394 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20233647 | 30mg | Category A (甲) | XC08CAX066A011010204647 | NHSA |
| 江西山香药业有限公司 | 国药准字H20243688 | 30mg | Category A (甲) | XC08CAX066A011010205345 | NHSA |
| 海南先声药业有限公司 | 国药准字H20213314 | 30mg | Category A (甲) | XC08CAX066A011010205849 | NHSA |
| 山西同达药业有限公司 | 国药准字H20234580 | 60mg | Category A (甲) | XC08CAX066A011010206183 | NHSA |
| 湖南润兴药业有限公司 | 国药准字H20234615 | 30mg | Category A (甲) | XC08CAX066A011010281227 | NHSA |
| 合肥华方医药科技有限公司 | 国药准字H20234152 | 30mg | Category A (甲) | XC08CAX066A011010282856 | NHSA |
| 复星医药(徐州)有限公司 | 国药准字H20255231 | 30mg | Category A (甲) | XC08CAX066A011010285458 | NHSA |
| Bayer AG | 国药准字J20180025 | 30mg | Category A (甲) | XC08CAX066A011010300002 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011010300044 | NHSA |
| 上海现代制药股份有限公司 | 国药准字H20000079 | 30mg | Category A (甲) | XC08CAX066A011010300785 | NHSA |
| 广州一品红制药有限公司 | 国药准字H20223061 | 30mg | Category A (甲) | XC08CAX066A011010301012 | NHSA |
| 常州制药厂有限公司 | 国药准字H20233478 | 30mg | Category A (甲) | XC08CAX066A011010301397 | NHSA |
| 南京易亨制药有限公司 | 国药准字H20203375 | 30mg | Category A (甲) | XC08CAX066A011010301605 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011010302770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011010302851 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H20244594 | 30mg | Category A (甲) | XC08CAX066A011010302959 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20234506 | 30mg | Category A (甲) | XC08CAX066A011010303094 | NHSA |
| 华润双鹤利民药业(济南)有限公司 | 国药准字H20223465 | 30mg | Category A (甲) | XC08CAX066A011010303973 | NHSA |
| 青岛百洋制药有限公司 | 国药准字H20213315 | 30mg | Category A (甲) | XC08CAX066A011010304023 | NHSA |
| 青岛黄海制药有限责任公司 | 国药准字H20249162 | 30mg | Category A (甲) | XC08CAX066A011010304043 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011010304175 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249648 | 30mg | Category A (甲) | XC08CAX066A011010304188 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011010304240 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011010304394 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20233647 | 30mg | Category A (甲) | XC08CAX066A011010304647 | NHSA |
| 江西山香药业有限公司 | 国药准字H20243688 | 30mg | Category A (甲) | XC08CAX066A011010305345 | NHSA |
| 海南先声药业有限公司 | 国药准字H20213314 | 30mg | Category A (甲) | XC08CAX066A011010305849 | NHSA |
| 山西同达药业有限公司 | 国药准字H20234580 | 60mg | Category A (甲) | XC08CAX066A011010306183 | NHSA |
| 湖南润兴药业有限公司 | 国药准字H20234615 | 30mg | Category A (甲) | XC08CAX066A011010381227 | NHSA |
| 合肥华方医药科技有限公司 | 国药准字H20234152 | 30mg | Category A (甲) | XC08CAX066A011010382856 | NHSA |
| Bayer AG | 国药准字J20180025 | 30mg | Category A (甲) | XC08CAX066A011010400002 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011010400044 | NHSA |
| 上海现代制药股份有限公司 | 国药准字H20000079 | 30mg | Category A (甲) | XC08CAX066A011010400785 | NHSA |
| 常州制药厂有限公司 | 国药准字H20233478 | 30mg | Category A (甲) | XC08CAX066A011010401397 | NHSA |
| 南京易亨制药有限公司 | 国药准字H20203375 | 30mg | Category A (甲) | XC08CAX066A011010401605 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011010402770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011010402851 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20234506 | 30mg | Category A (甲) | XC08CAX066A011010403094 | NHSA |
| 华润双鹤利民药业(济南)有限公司 | 国药准字H20223465 | 30mg | Category A (甲) | XC08CAX066A011010403973 | NHSA |
| 青岛百洋制药有限公司 | 国药准字H20213315 | 30mg | Category A (甲) | XC08CAX066A011010404023 | NHSA |
| 青岛黄海制药有限责任公司 | 国药准字H20249162 | 30mg | Category A (甲) | XC08CAX066A011010404043 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011010404175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011010404240 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011010404394 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20233647 | 30mg | Category A (甲) | XC08CAX066A011010404647 | NHSA |
| 江西山香药业有限公司 | 国药准字H20243688 | 30mg | Category A (甲) | XC08CAX066A011010405345 | NHSA |
| 湖南润兴药业有限公司 | 国药准字H20234615 | 30mg | Category A (甲) | XC08CAX066A011010481227 | NHSA |
| 合肥华方医药科技有限公司 | 国药准字H20234152 | 30mg | Category A (甲) | XC08CAX066A011010482856 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011010500044 | NHSA |
| 常州制药厂有限公司 | 国药准字H20233478 | 30mg | Category A (甲) | XC08CAX066A011010501397 | NHSA |
| 南京易亨制药有限公司 | 国药准字H20203375 | 30mg | Category A (甲) | XC08CAX066A011010501605 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011010502770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011010502851 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20234506 | 30mg | Category A (甲) | XC08CAX066A011010503094 | NHSA |
| 华润双鹤利民药业(济南)有限公司 | 国药准字H20223465 | 30mg | Category A (甲) | XC08CAX066A011010503973 | NHSA |
| 青岛百洋制药有限公司 | 国药准字H20213315 | 30mg | Category A (甲) | XC08CAX066A011010504023 | NHSA |
| 青岛黄海制药有限责任公司 | 国药准字H20249162 | 30mg | Category A (甲) | XC08CAX066A011010504043 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011010504175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011010504240 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011010504394 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20233647 | 30mg | Category A (甲) | XC08CAX066A011010504647 | NHSA |
| 湖南润兴药业有限公司 | 国药准字H20234615 | 30mg | Category A (甲) | XC08CAX066A011010581227 | NHSA |
| 合肥华方医药科技有限公司 | 国药准字H20234152 | 30mg | Category A (甲) | XC08CAX066A011010582856 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011010600044 | NHSA |
| 常州制药厂有限公司 | 国药准字H20233478 | 30mg | Category A (甲) | XC08CAX066A011010601397 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011010602770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011010602851 | NHSA |
| 乐普药业股份有限公司 | 国药准字H20234506 | 30mg | Category A (甲) | XC08CAX066A011010603094 | NHSA |
| 华润双鹤利民药业(济南)有限公司 | 国药准字H20223465 | 30mg | Category A (甲) | XC08CAX066A011010603973 | NHSA |
| 青岛百洋制药有限公司 | 国药准字H20213315 | 30mg | Category A (甲) | XC08CAX066A011010604023 | NHSA |
| 青岛黄海制药有限责任公司 | 国药准字H20249162 | 30mg | Category A (甲) | XC08CAX066A011010604043 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011010604175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011010604240 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011010604394 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20233647 | 30mg | Category A (甲) | XC08CAX066A011010604647 | NHSA |
| 湖南润兴药业有限公司 | 国药准字H20234615 | 30mg | Category A (甲) | XC08CAX066A011010681227 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011010700044 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011010702770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011010702851 | NHSA |
| 华润双鹤利民药业(济南)有限公司 | 国药准字H20223465 | 30mg | Category A (甲) | XC08CAX066A011010703973 | NHSA |
| 青岛百洋制药有限公司 | 国药准字H20213315 | 30mg | Category A (甲) | XC08CAX066A011010704023 | NHSA |
| 青岛黄海制药有限责任公司 | 国药准字H20249162 | 30mg | Category A (甲) | XC08CAX066A011010704043 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011010704175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011010704240 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011010704394 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20233647 | 30mg | Category A (甲) | XC08CAX066A011010704647 | NHSA |
| 湖南润兴药业有限公司 | 国药准字H20234615 | 30mg | Category A (甲) | XC08CAX066A011010781227 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011010800044 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011010802770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011010802851 | NHSA |
| 华润双鹤利民药业(济南)有限公司 | 国药准字H20223465 | 30mg | Category A (甲) | XC08CAX066A011010803973 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011010804175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011010804240 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011010804394 | NHSA |
| 湖南润兴药业有限公司 | 国药准字H20234615 | 30mg | Category A (甲) | XC08CAX066A011010881227 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011010900044 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011010902770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011010902851 | NHSA |
| 华润双鹤利民药业(济南)有限公司 | 国药准字H20223465 | 30mg | Category A (甲) | XC08CAX066A011010903973 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011010904175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011010904240 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011011000044 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011011002770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011011002851 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011011004175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011011004240 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011011100044 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H20223238 | 30mg | Category A (甲) | XC08CAX066A011011102770 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011011102851 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011011104175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011011104240 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011011200044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011011204175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011011204240 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011011300044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011011304175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011011304240 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011011400044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011011404175 | NHSA |
| 烟台鲁银药业有限公司 | 国药准字H20234525 | 30mg | Category A (甲) | XC08CAX066A011011404240 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011011500044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011011504175 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011011600044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011011604175 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011011700044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011011704175 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011011800044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011011804175 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011011900044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011011904175 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011012000044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011012004175 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011012100044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011012104175 | NHSA |
| 北京红林制药有限公司 | 国药准字H20103238 | 30mg | Category A (甲) | XC08CAX066A011012200044 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011012204175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011012304175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011012404175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011012504175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011012604175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011012704175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011012804175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011012904175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011013004175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011013104175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011013204175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011013304175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011013404175 | NHSA |
| 广州九瑞药业有限公司 | 国药准字H20223413 | 30mg | Category A (甲) | XC08CAX066A011013504175 | NHSA |
| bayer ag | 国药准字J20180026 | 60mg | Category A (甲) | XC08CAX066A011020100002 | NHSA |
| 上海现代制药股份有限公司 | 国药准字H20000079 | 30mg | Category A (甲) | XC08CAX066A011020100785 | NHSA |
| 广州一品红制药有限公司 | 国药准字H20223060 | 60mg | Category A (甲) | XC08CAX066A011020101012 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244499 | 60mg | Category A (甲) | XC08CAX066A011020102851 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011020104394 | NHSA |
| Bayer AG | H20171323 | 60mg | Category A (甲) | XC08CAX066A011020178269 | NHSA |
| bayer ag | 国药准字J20180026 | 60mg | Category A (甲) | XC08CAX066A011020200002 | NHSA |
| 广州一品红制药有限公司 | 国药准字H20223060 | 60mg | Category A (甲) | XC08CAX066A011020201012 | NHSA |
| bayer ag | 国药准字J20180026 | 60mg | Category A (甲) | XC08CAX066A011020300002 | NHSA |
| 广州一品红制药有限公司 | 国药准字H20223060 | 60mg | Category A (甲) | XC08CAX066A011020301012 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011020904394 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011021004394 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011021104394 | NHSA |
| 合肥立方制药股份有限公司 | 国药准字H20213898 | 30mg | Category A (甲) | XC08CAX066A011021204394 | NHSA |
| Bayer AG | 国药准字HJ20171342 | 30mg | Category A (甲) | XC08CAX066A011030378269 | NHSA |
| Bayer AG | 国药准字HJ20171342 | 30mg | Category A (甲) | XC08CAX066A011030478269 | NHSA |
| Bayer AG | 国药准字HJ20171342 | 30mg | Category A (甲) | XC08CAX066A011030578269 | NHSA |
| 山西双雁药业有限公司 | 国药准字H20244498 | 30mg | Category A (甲) | XC08CAX066A011011202851 | 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 7 distinct first applicants.
Supplement 4 · Generic 2 · Import re-registration 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 烟台鲁银药业有限公司 | CYHB2601677 | Supplement | 2026/09/03 | Not stated by source | CDE |
| 山东鲁抗医药集团赛特有限责任公司;烟台鲁银药业有限公司 | CYHS2601467 | Generic | 2026/06/23 | Not stated by source | CDE |
| 广州一品红制药有限公司;广州市联瑞制药有限公司 | CYHB2600153 | Supplement | 2026/01/27 | Not stated by source | CDE |
| 华润双鹤利民药业（济南）有限公司 | CYHB2600017 | Supplement | 2026/01/07 | Not stated by source | CDE |
| 青岛百洋制药有限公司 | CYHB2401511 | Supplement | 2024/09/18 | Not stated by source | CDE |
| 山东宜岛康制药有限公司;烟台鲁银药业有限公司 | CYHS2602595 | Generic | 2026/10/22 | Not stated by source | CDE |
| Bayer AG;- | JYHZ2600289 | Import re-registration | 2026/11/03 | Not stated by source | CDE |
| Bayer AG;- | JYHZ2600288 | Import re-registration | 2026/11/03 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 35 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 硝苯地平 | 江苏威奇达药业有限公司 | Y20250001436 | I | Exact ingredient | 2025/12/30 | CDE |
| 硝苯地平 | 河北山姆士药业有限公司 | Y20240000120 | A | Exact ingredient | 2025/09/04 | CDE |
| 硝苯地平 | 陕西西岳制药（扶风）有限公司 | Y20230001307 | A | Exact ingredient | 2026/05/20 | CDE |
| 硝苯地平 | 乐声药业石家庄有限公司 | Y20230001229 | A | Exact ingredient | 2026/07/22 | CDE |
| 硝苯地平 | 合肥立方制药股份有限公司 | Y20220000847 | A | Exact ingredient | 2026/01/28 | CDE |
| 硝苯地平 | 寿光富康制药有限公司 | Y20220000482 | A | Exact ingredient | 2024/08/15 | CDE |
| 硝苯地平 | Sicor Societa’ Italiana Corticosteroidi S.r.l. | Y20210000689 | A | Exact ingredient | 2025/05/25 | CDE |
| 硝苯地平 | 亚宝药业集团股份有限公司 | Y20210000565 | A | Exact ingredient | 2026/03/21 | CDE |
| 硝苯地平 | 云鹏医药集团有限公司 | Y20210000454 | A | Exact ingredient | 2024/12/27 | CDE |
| 硝苯地平 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20200000964 | A | Exact ingredient | 2022/10/31 | CDE |
| 硝苯地平 | 陕西西岳制药有限公司 | Y20190008695 | A | Exact ingredient | 2025/07/23 | CDE |
| 硝苯地平 | 广东逸舒制药股份有限公司 | Y20190008505 | A | Exact ingredient | — | CDE |
| 硝苯地平 | 上海玉瑞生物科技（安阳）药业有限公司 | Y20190008484 | A | Exact ingredient | 2025/04/23 | CDE |
| 硝苯地平 | 重庆青阳药业有限公司 | Y20190005394 | A | Exact ingredient | 2025/09/16 | CDE |
| 硝苯地平 | 黄石黄抗药业有限公司 | Y20190004882 | A | Exact ingredient | — | CDE |
| 硝苯地平 | 赤峰艾克制药科技股份有限公司 | Y20190004876 | A | Exact ingredient | 2024/10/12 | CDE |
| 硝苯地平 | 石药集团欧意药业有限公司 | Y20190004810 | A | Exact ingredient | 2024/05/28 | CDE |
| 硝苯地平 | 山西双雁药业有限公司 | Y20190004608 | A | Exact ingredient | 2025/08/23 | CDE |
| 硝苯地平 | 常州四药制药有限公司 | Y20190004554 | A | Exact ingredient | 2025/07/05 | CDE |
| 硝苯地平 | 国药集团汕头金石制药有限公司 | Y20190004273 | A | Exact ingredient | — | CDE |
| 硝苯地平 | 葵花药业集团佳木斯鹿灵制药有限公司 | Y20190003728 | A | Exact ingredient | 2025/05/13 | CDE |
| 硝苯地平 | 湖北欧立制药有限公司 | Y20190003677 | A | Exact ingredient | 2026/06/26 | CDE |
| 硝苯地平 | 浙江海正药业股份有限公司 | Y20190003540 | A | Exact ingredient | — | CDE |
| 硝苯地平 | 万邦德制药集团有限公司 | Y20190003389 | A | Exact ingredient | 2024/08/31 | CDE |
| 硝苯地平 | 苏州弘森药业股份有限公司 | Y20190003204 | A | Exact ingredient | 2025/06/07 | CDE |
| 硝苯地平 | 江苏恒沣药业有限公司 | Y20190002980 | A | Exact ingredient | — | CDE |
| 硝苯地平 | 河北广祥制药有限公司 | Y20190002960 | A | Exact ingredient | 2025/02/18 | CDE |
| 硝苯地平 | 焦作福瑞堂制药有限公司 | Y20190002906 | A | Exact ingredient | 2024/12/14 | CDE |
| 硝苯地平 | 北京市燕京药业有限公司 | Y20190002517 | A | Exact ingredient | — | CDE |
| 硝苯地平 | 辽源市百康药业有限责任公司 | Y20190002132 | A | Exact ingredient | 2026/03/04 | CDE |
| 硝苯地平 | 烟台鲁银药业有限公司 | Y20190002013 | A | Exact ingredient | 2025/01/25 | CDE |
| 硝苯地平 | 北京斯利安药业有限公司 | Y20190001688 | A | Exact ingredient | — | CDE |
| 硝苯地平 | Dipharma Francis S.r.l. | Y20180001253 | A | Exact ingredient | 2023/07/31 | CDE |
| 硝苯地平 | MOEHS IBERICA S.L. | Y20180000899 | A | Exact ingredient | 2024/03/07 | CDE |
| 硝苯地平 | 青岛黄海生物制药有限责任公司 | Y20170000826 | A | Exact ingredient | 2022/09/08 | CDE |
| 硝苯地平 | 迪嘉药业集团股份有限公司 | Y20170000113 | A | Exact ingredient | 2026/01/16 | 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.
-
2026/11/09Supplement delivery
华润双鹤利民药业（济南）有限公司
CYHB2600017
Fact date: 2026/11/09 · Publication date: 2026/11/10 · Site observation date: 2026/11/10
Supplemental application; excluded from new marketing approvals.
View source · Table row 9 ↗ -
2026/11/03Accepted
-
2026/11/03Accepted
-
2026/10/22Accepted
山东宜岛康制药有限公司;烟台鲁银药业有限公司
CYHS2602595
Fact date: 2026/10/22 · Site observation date: 2026/10/23
View source ↗ -
2026/09/03Accepted
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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