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As of 14 November 2026, for Nifedipine Controlled-release Tablets, 7 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 28 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 4 applicationsNo 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.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
Catalogue holders28View records ↓
Under-review filings7View 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 |
|---|---|---|---|---|---|---|
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H20265115 | 2026/07/08 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | 国药准字H20255231 | 2025/08/26 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249648 | 2024/12/01 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | Qingdao Huang Hai Biopharmaceutical Co., Ltd. romanized | 国药准字H20249162 | 2024/10/22 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244499 | 2024/07/30 | 60mg | Not stated by source | CDE |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 2024/07/30 | 30mg | Not stated by source | CDE |
| Ya Bao Pharma Group Co., Ltd. romanized | Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20244594 | 2024/07/30 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20243688 | 2024/05/15 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jin Zhou Ao Hong Pharma Co., Ltd. romanized | Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20234668 | 2023/12/19 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanxi Tong Da Pharma Co., Ltd. romanized | Shanxi Tong Da Pharma Co., Ltd. romanized | 国药准字H20234580 | 2023/12/05 | 60mg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Xing Yin Pharma Group Co., Ltd. romanized | Nanjing Xing Yin Pharma Group Co., Ltd. romanized | 国药准字H20234610 | 2023/12/05 | 30mg | Not stated by source | CDE |
| Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized | Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized | 国药准字H20234615 | 2023/12/05 | 30mg | Not stated by source | CDE |
| Le Pu Pharma Co., Ltd. romanized | Le Pu Pharma Co., Ltd. romanized | 国药准字H20234506 | 2023/11/21 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 2023/11/21 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized | Hefei Si Pu Rui Pharma Co., Ltd. romanized | 国药准字H20234152 | 2023/09/12 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| De Zhou De Yao Pharmaceutical Co., Ltd. romanized | De Zhou De Yao Pharmaceutical Co., Ltd. romanized | 国药准字H20233735 | 2023/06/14 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20233647 | 2023/06/07 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20223465 | 2022/06/30 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | Zi Bo Wan Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20223413 | 2022/06/16 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 2022/04/19 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Yangtze River Pharmaceutical Group Co., Ltd | Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20223165 | 2022/03/22 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H20000079 | 2022/02/16 | 30mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20223060 | 2022/01/30 | 60mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20223061 | 2022/01/30 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 2021/11/24 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 2021/04/30 | 30mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213315 | 2021/04/27 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20213314 | 2021/04/27 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20203375 | 2020/07/29 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Bayer Pharma AG | Bayer Pharma AG | H20130332 | 1994/11/02 | 30mg | Imported originator drug | CDE |
| Bayer Pharma AG | Bayer Pharma AG | H20130334 | 1994/11/02 | 60mg | Imported originator drug | 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 | XC08CAX066A011010100002 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011010100044 | NHSA |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H20000079 | 30mg | Category A | XC08CAX066A011010100785 | NHSA |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H20265115 | 30mg | Category A | XC08CAX066A011010100886 | NHSA |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20223061 | 30mg | Category A | XC08CAX066A011010101012 | NHSA |
| Jin Zhou Ao Hong Pharma Co., Ltd. romanized | 国药准字H20234668 | 30mg | Category A | XC08CAX066A011010101190 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20233478 | 30mg | Category A | XC08CAX066A011010101397 | NHSA |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20203375 | 30mg | Category A | XC08CAX066A011010101605 | NHSA |
| Yangtze River Pharmaceutical Group Co., Ltd | 国药准字H20223165 | 30mg | Category A | XC08CAX066A011010101749 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011010102770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011010102851 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20244594 | 30mg | Category A | XC08CAX066A011010102959 | NHSA |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H20234506 | 30mg | Category A | XC08CAX066A011010103094 | NHSA |
| De Zhou De Yao Pharmaceutical Co., Ltd. romanized | 国药准字H20233735 | 30mg | Category A | XC08CAX066A011010103942 | NHSA |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20223465 | 30mg | Category A | XC08CAX066A011010103973 | NHSA |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213315 | 30mg | Category A | XC08CAX066A011010104023 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20249162 | 30mg | Category A | XC08CAX066A011010104043 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011010104175 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249648 | 30mg | Category A | XC08CAX066A011010104188 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011010104240 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011010104394 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20233647 | 30mg | Category A | XC08CAX066A011010104647 | NHSA |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20243688 | 30mg | Category A | XC08CAX066A011010105345 | NHSA |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20213314 | 30mg | Category A | XC08CAX066A011010105849 | NHSA |
| Shanxi Tong Da Pharma Co., Ltd. romanized | 国药准字H20234580 | 60mg | Category A | XC08CAX066A011010106183 | NHSA |
| Bayer AG | H20171341 | 30mg | Category A | XC08CAX066A011010178269 | NHSA |
| Hunan Run Xing Pharma Co., Ltd. romanized | 国药准字H20234615 | 30mg | Category A | XC08CAX066A011010181227 | NHSA |
| Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234152 | 30mg | Category A | XC08CAX066A011010182856 | NHSA |
| Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | 国药准字H20255231 | 30mg | Category A | XC08CAX066A011010185458 | NHSA |
| Bayer AG | 国药准字J20180025 | 30mg | Category A | XC08CAX066A011010200002 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011010200044 | NHSA |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H20000079 | 30mg | Category A | XC08CAX066A011010200785 | NHSA |
| TIANJIN LISHENG PHARMACEUTICAL CO., LTD | 国药准字H20265115 | 30mg | Category A | XC08CAX066A011010200886 | NHSA |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20223061 | 30mg | Category A | XC08CAX066A011010201012 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20233478 | 30mg | Category A | XC08CAX066A011010201397 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011010202770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011010202851 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20244594 | 30mg | Category A | XC08CAX066A011010202959 | NHSA |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H20234506 | 30mg | Category A | XC08CAX066A011010203094 | NHSA |
| De Zhou De Yao Pharmaceutical Co., Ltd. romanized | 国药准字H20233735 | 30mg | Category A | XC08CAX066A011010203942 | NHSA |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20223465 | 30mg | Category A | XC08CAX066A011010203973 | NHSA |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213315 | 30mg | Category A | XC08CAX066A011010204023 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20249162 | 30mg | Category A | XC08CAX066A011010204043 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011010204175 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249648 | 30mg | Category A | XC08CAX066A011010204188 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011010204240 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011010204394 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20233647 | 30mg | Category A | XC08CAX066A011010204647 | NHSA |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20243688 | 30mg | Category A | XC08CAX066A011010205345 | NHSA |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20213314 | 30mg | Category A | XC08CAX066A011010205849 | NHSA |
| Shanxi Tong Da Pharma Co., Ltd. romanized | 国药准字H20234580 | 60mg | Category A | XC08CAX066A011010206183 | NHSA |
| Hunan Run Xing Pharma Co., Ltd. romanized | 国药准字H20234615 | 30mg | Category A | XC08CAX066A011010281227 | NHSA |
| Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234152 | 30mg | Category A | XC08CAX066A011010282856 | NHSA |
| Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | 国药准字H20255231 | 30mg | Category A | XC08CAX066A011010285458 | NHSA |
| Bayer AG | 国药准字J20180025 | 30mg | Category A | XC08CAX066A011010300002 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011010300044 | NHSA |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H20000079 | 30mg | Category A | XC08CAX066A011010300785 | NHSA |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20223061 | 30mg | Category A | XC08CAX066A011010301012 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20233478 | 30mg | Category A | XC08CAX066A011010301397 | NHSA |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20203375 | 30mg | Category A | XC08CAX066A011010301605 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011010302770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011010302851 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H20244594 | 30mg | Category A | XC08CAX066A011010302959 | NHSA |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H20234506 | 30mg | Category A | XC08CAX066A011010303094 | NHSA |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20223465 | 30mg | Category A | XC08CAX066A011010303973 | NHSA |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213315 | 30mg | Category A | XC08CAX066A011010304023 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20249162 | 30mg | Category A | XC08CAX066A011010304043 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011010304175 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20249648 | 30mg | Category A | XC08CAX066A011010304188 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011010304240 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011010304394 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20233647 | 30mg | Category A | XC08CAX066A011010304647 | NHSA |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20243688 | 30mg | Category A | XC08CAX066A011010305345 | NHSA |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20213314 | 30mg | Category A | XC08CAX066A011010305849 | NHSA |
| Shanxi Tong Da Pharma Co., Ltd. romanized | 国药准字H20234580 | 60mg | Category A | XC08CAX066A011010306183 | NHSA |
| Hunan Run Xing Pharma Co., Ltd. romanized | 国药准字H20234615 | 30mg | Category A | XC08CAX066A011010381227 | NHSA |
| Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234152 | 30mg | Category A | XC08CAX066A011010382856 | NHSA |
| Bayer AG | 国药准字J20180025 | 30mg | Category A | XC08CAX066A011010400002 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011010400044 | NHSA |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H20000079 | 30mg | Category A | XC08CAX066A011010400785 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20233478 | 30mg | Category A | XC08CAX066A011010401397 | NHSA |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20203375 | 30mg | Category A | XC08CAX066A011010401605 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011010402770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011010402851 | NHSA |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H20234506 | 30mg | Category A | XC08CAX066A011010403094 | NHSA |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20223465 | 30mg | Category A | XC08CAX066A011010403973 | NHSA |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213315 | 30mg | Category A | XC08CAX066A011010404023 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20249162 | 30mg | Category A | XC08CAX066A011010404043 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011010404175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011010404240 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011010404394 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20233647 | 30mg | Category A | XC08CAX066A011010404647 | NHSA |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20243688 | 30mg | Category A | XC08CAX066A011010405345 | NHSA |
| Hunan Run Xing Pharma Co., Ltd. romanized | 国药准字H20234615 | 30mg | Category A | XC08CAX066A011010481227 | NHSA |
| Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234152 | 30mg | Category A | XC08CAX066A011010482856 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011010500044 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20233478 | 30mg | Category A | XC08CAX066A011010501397 | NHSA |
| Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20203375 | 30mg | Category A | XC08CAX066A011010501605 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011010502770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011010502851 | NHSA |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H20234506 | 30mg | Category A | XC08CAX066A011010503094 | NHSA |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20223465 | 30mg | Category A | XC08CAX066A011010503973 | NHSA |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213315 | 30mg | Category A | XC08CAX066A011010504023 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20249162 | 30mg | Category A | XC08CAX066A011010504043 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011010504175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011010504240 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011010504394 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20233647 | 30mg | Category A | XC08CAX066A011010504647 | NHSA |
| Hunan Run Xing Pharma Co., Ltd. romanized | 国药准字H20234615 | 30mg | Category A | XC08CAX066A011010581227 | NHSA |
| Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234152 | 30mg | Category A | XC08CAX066A011010582856 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011010600044 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20233478 | 30mg | Category A | XC08CAX066A011010601397 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011010602770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011010602851 | NHSA |
| Le Pu Pharma Co., Ltd. romanized | 国药准字H20234506 | 30mg | Category A | XC08CAX066A011010603094 | NHSA |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20223465 | 30mg | Category A | XC08CAX066A011010603973 | NHSA |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213315 | 30mg | Category A | XC08CAX066A011010604023 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20249162 | 30mg | Category A | XC08CAX066A011010604043 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011010604175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011010604240 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011010604394 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20233647 | 30mg | Category A | XC08CAX066A011010604647 | NHSA |
| Hunan Run Xing Pharma Co., Ltd. romanized | 国药准字H20234615 | 30mg | Category A | XC08CAX066A011010681227 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011010700044 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011010702770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011010702851 | NHSA |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20223465 | 30mg | Category A | XC08CAX066A011010703973 | NHSA |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20213315 | 30mg | Category A | XC08CAX066A011010704023 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20249162 | 30mg | Category A | XC08CAX066A011010704043 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011010704175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011010704240 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011010704394 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20233647 | 30mg | Category A | XC08CAX066A011010704647 | NHSA |
| Hunan Run Xing Pharma Co., Ltd. romanized | 国药准字H20234615 | 30mg | Category A | XC08CAX066A011010781227 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011010800044 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011010802770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011010802851 | NHSA |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20223465 | 30mg | Category A | XC08CAX066A011010803973 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011010804175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011010804240 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011010804394 | NHSA |
| Hunan Run Xing Pharma Co., Ltd. romanized | 国药准字H20234615 | 30mg | Category A | XC08CAX066A011010881227 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011010900044 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011010902770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011010902851 | NHSA |
| Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized | 国药准字H20223465 | 30mg | Category A | XC08CAX066A011010903973 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011010904175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011010904240 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011011000044 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011011002770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011011002851 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011011004175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011011004240 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011011100044 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20223238 | 30mg | Category A | XC08CAX066A011011102770 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | XC08CAX066A011011102851 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011011104175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011011104240 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011011200044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011011204175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011011204240 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011011300044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011011304175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011011304240 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011011400044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011011404175 | NHSA |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20234525 | 30mg | Category A | XC08CAX066A011011404240 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011011500044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011011504175 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011011600044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011011604175 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011011700044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011011704175 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011011800044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011011804175 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011011900044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011011904175 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011012000044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011012004175 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011012100044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011012104175 | NHSA |
| Beijing Hong Lin Pharmaceutical Co., Ltd. romanized | 国药准字H20103238 | 30mg | Category A | XC08CAX066A011012200044 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011012204175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011012304175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011012404175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011012504175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011012604175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011012704175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011012804175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011012904175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011013004175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011013104175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011013204175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011013304175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011013404175 | NHSA |
| Guangzhou Jiu Rui Pharma Co., Ltd. romanized | 国药准字H20223413 | 30mg | Category A | XC08CAX066A011013504175 | NHSA |
| bayer ag | 国药准字J20180026 | 60mg | Category A | XC08CAX066A011020100002 | NHSA |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H20000079 | 30mg | Category A | XC08CAX066A011020100785 | NHSA |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20223060 | 60mg | Category A | XC08CAX066A011020101012 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244499 | 60mg | Category A | XC08CAX066A011020102851 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011020104394 | NHSA |
| Bayer AG | H20171323 | 60mg | Category A | XC08CAX066A011020178269 | NHSA |
| bayer ag | 国药准字J20180026 | 60mg | Category A | XC08CAX066A011020200002 | NHSA |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20223060 | 60mg | Category A | XC08CAX066A011020201012 | NHSA |
| bayer ag | 国药准字J20180026 | 60mg | Category A | XC08CAX066A011020300002 | NHSA |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20223060 | 60mg | Category A | XC08CAX066A011020301012 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011020904394 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011021004394 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011021104394 | NHSA |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | 国药准字H20213898 | 30mg | Category A | XC08CAX066A011021204394 | NHSA |
| Bayer AG | 国药准字HJ20171342 | 30mg | Category A | XC08CAX066A011030378269 | NHSA |
| Bayer AG | 国药准字HJ20171342 | 30mg | Category A | XC08CAX066A011030478269 | NHSA |
| Bayer AG | 国药准字HJ20171342 | 30mg | Category A | XC08CAX066A011030578269 | NHSA |
| Shanxi Shuang Yan Pharma Co., Ltd. romanized | 国药准字H20244498 | 30mg | Category A | 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: 7 filings and 6 distinct first applicants.
Supplement 3 · Generic 2 · Import re-registration 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHB2601677 | Supplement | 2026/09/03 | Not stated by source | CDE |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2601467 | Generic | 2026/06/23 | Not stated by source | CDE |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized; Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | CYHB2600153 | Supplement | 2026/01/27 | Not stated by source | CDE |
| Qingdao Bai Yang Pharmaceutical Co., Ltd. romanized | CYHB2401511 | Supplement | 2024/09/18 | Not stated by source | CDE |
| Shandong Yi Dao Kang Pharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2602595 | Generic | 2026/10/22 | Not stated by source | CDE |
| Bayer AG; Name not romanized | JYHZ2600289 | Import re-registration | 2026/11/03 | Not stated by source | CDE |
| Bayer AG; Name not romanized | 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.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2601467 | Generic | 2026/06/23 | Not stated by source | CDE |
| Shandong Yi Dao Kang Pharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2602595 | Generic | 2026/10/22 | Not stated by source | CDE |
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 · No verified English name | Jiangsu Wei Qi Da Pharma Co., Ltd. romanized | Y20250001436 | I | Exact ingredient | 2025/12/30 | CDE |
| 硝苯地平 · No verified English name | Hebei Shan Mu Shi Pharma Co., Ltd. romanized | Y20240000120 | A | Exact ingredient | 2025/09/04 | CDE |
| 硝苯地平 · No verified English name | Shaanxi Xi Yue Pharmaceutical (Fu Feng) Co., Ltd. romanized | Y20230001307 | A | Exact ingredient | 2026/05/20 | CDE |
| 硝苯地平 · No verified English name | Le Sheng Pharma Shijiazhuang Co., Ltd. romanized | Y20230001229 | A | Exact ingredient | 2026/07/22 | CDE |
| 硝苯地平 · No verified English name | Hefei Li Fang Pharmaceutical Co., Ltd. romanized | Y20220000847 | A | Exact ingredient | 2026/01/28 | CDE |
| 硝苯地平 · No verified English name | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | Y20220000482 | A | Exact ingredient | 2024/08/15 | CDE |
| 硝苯地平 · No verified English name | Sicor Societa’ Italiana Corticosteroidi S.r.l. | Y20210000689 | A | Exact ingredient | 2025/05/25 | CDE |
| 硝苯地平 · No verified English name | Ya Bao Pharma Group Co., Ltd. romanized | Y20210000565 | A | Exact ingredient | 2026/03/21 | CDE |
| 硝苯地平 · No verified English name | Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20210000454 | A | Exact ingredient | 2024/12/27 | CDE |
| 硝苯地平 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20200000964 | A | Exact ingredient | 2022/10/31 | CDE |
| 硝苯地平 · No verified English name | Shaanxi Xi Yue Pharmaceutical Co., Ltd. romanized | Y20190008695 | A | Exact ingredient | 2025/07/23 | CDE |
| 硝苯地平 · No verified English name | Guangdong Yi Shu Pharmaceutical Co., Ltd. romanized | Y20190008505 | A | Exact ingredient | — | CDE |
| 硝苯地平 · No verified English name | Shanghai Yu Rui Bio Technology (An Yang) Pharma Co., Ltd. romanized | Y20190008484 | A | Exact ingredient | 2025/04/23 | CDE |
| 硝苯地平 · No verified English name | Chongqing Qing Yang Pharma Co., Ltd. romanized | Y20190005394 | A | Exact ingredient | 2025/09/16 | CDE |
| 硝苯地平 · No verified English name | Huang Shi Huang Kang Pharma Co., Ltd. romanized | Y20190004882 | A | Exact ingredient | — | CDE |
| 硝苯地平 · No verified English name | Chi Feng Ai Ke Pharmaceutical Technology Co., Ltd. romanized | Y20190004876 | A | Exact ingredient | 2024/10/12 | CDE |
| 硝苯地平 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20190004810 | A | Exact ingredient | 2024/05/28 | CDE |
| 硝苯地平 · No verified English name | Shanxi Shuang Yan Pharma Co., Ltd. romanized | Y20190004608 | A | Exact ingredient | 2025/08/23 | CDE |
| 硝苯地平 · No verified English name | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized | Y20190004554 | A | Exact ingredient | 2025/07/05 | CDE |
| 硝苯地平 · No verified English name | Guo Yao Group Shan Tou Jin Shi Pharmaceutical Co., Ltd. romanized | Y20190004273 | A | Exact ingredient | — | CDE |
| 硝苯地平 · No verified English name | Kui Hua Pharma Group Jia Mu Si Lu Ling Pharmaceutical Co., Ltd. romanized | Y20190003728 | A | Exact ingredient | 2025/05/13 | CDE |
| 硝苯地平 · No verified English name | Hubei Ou Li Pharmaceutical Co., Ltd. romanized | Y20190003677 | A | Exact ingredient | 2026/06/26 | CDE |
| 硝苯地平 · No verified English name | Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20190003540 | A | Exact ingredient | — | CDE |
| 硝苯地平 · No verified English name | Wan Bang De Pharmaceutical Group Co., Ltd. romanized | Y20190003389 | A | Exact ingredient | 2024/08/31 | CDE |
| 硝苯地平 · No verified English name | Suzhou Hong Sen Pharma Co., Ltd. romanized | Y20190003204 | A | Exact ingredient | 2025/06/07 | CDE |
| 硝苯地平 · No verified English name | Jiangsu Heng Feng Pharma Co., Ltd. romanized | Y20190002980 | A | Exact ingredient | — | CDE |
| 硝苯地平 · No verified English name | Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20190002960 | A | Exact ingredient | 2025/02/18 | CDE |
| 硝苯地平 · No verified English name | Jiao Zuo Fu Rui Tang Pharmaceutical Co., Ltd. romanized | Y20190002906 | A | Exact ingredient | 2024/12/14 | CDE |
| 硝苯地平 · No verified English name | Beijing Shi Yan Jing Pharma Co., Ltd. romanized | Y20190002517 | A | Exact ingredient | — | CDE |
| 硝苯地平 · No verified English name | Liao Yuan Shi Bai Kang Pharma Co., Ltd. romanized | Y20190002132 | A | Exact ingredient | 2026/03/04 | CDE |
| 硝苯地平 · No verified English name | Yan Tai Lu Yin Pharma Co., Ltd. romanized | Y20190002013 | A | Exact ingredient | 2025/01/25 | CDE |
| 硝苯地平 · No verified English name | Beijing Si Li An Pharma Co., Ltd. romanized | Y20190001688 | A | Exact ingredient | — | CDE |
| 硝苯地平 · No verified English name | Dipharma Francis S.r.l. | Y20180001253 | A | Exact ingredient | 2023/07/31 | CDE |
| 硝苯地平 · No verified English name | MOEHS IBERICA S.L. | Y20180000899 | A | Exact ingredient | 2024/03/07 | CDE |
| 硝苯地平 · No verified English name | Qingdao Huang Hai Biopharmaceutical Co., Ltd. romanized | Y20170000826 | A | Exact ingredient | 2022/09/08 | CDE |
| 硝苯地平 · No verified English name | Di Jia Pharma Group Co., Ltd. romanized | 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: 2026/11/14 06:40. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/11/11No longer listed under review
Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
CYHB2600017
Fact date: 2026/11/11 · Site observation date: 2026/11/11
Accepted: 2026/01/07
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/10 (approval no.: —; approval date: 2026/11/09); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 9
NMPA · Table row 9 ↗ View source ↗ -
2026/11/09Supplement delivery
Hua Run Shuang He Li Min Pharma (Jinan) Co., Ltd. romanized
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
Bayer AG; Name not romanized
JYHZ2600289
Fact date: 2026/11/03 · Site observation date: 2026/11/04
View source ↗ -
2026/11/03Accepted
Bayer AG; Name not romanized
JYHZ2600288
Fact date: 2026/11/03 · Site observation date: 2026/11/04
View source ↗ -
2026/10/22Accepted
Shandong Yi Dao Kang Pharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
CYHS2602595
Fact date: 2026/10/22 · Site observation date: 2026/10/23
View source ↗ -
2026/09/03Accepted
Yan Tai Lu Yin Pharma Co., Ltd. romanized
CYHB2601677
Fact date: 2026/09/03 · Site observation date: 2026/10/21
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/14 06:44
- Chemical-drug catalogue
- Last successful update: 2026/11/14 06:40
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: 2026/11/14 06:43
- 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: 2026/11/14 18:32
First index-page publication dates: 2026-10-29 to 2026-11-13; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/14 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: 7/30; discovered pending details: 0. 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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