Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/10 07:27
Current coverage may be incomplete
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.
Loaded records: 5 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 2 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| 山东新华制药股份有限公司 | 新华制药(高密)有限公司 | 国药准字H10910081 | 2026/10/15 | 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 |
| 湖南科伦制药有限公司 | 湖南科伦制药有限公司 | 国药准字H20265033 | 2026/06/30 | 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 |
| 哈尔滨三联药业股份有限公司 | 兰西哈三联制药有限公司 | 国药准字H20255229 | 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 |
| — | 拜耳医药保健有限公司 | 国药准字H20003010 | 2000/11/02 | 30mg | Other drug (其他药品) | CDE |
| Bayer Vital GmbH | Bayer Pharma AG | H20130606 | 1993/02/05 | 30mg | 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.
Loaded records: 45 distinct approval numbers and 37 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 拜耳医药保健有限公司 | 国药准字H20003010 | 30mg | Category A (甲) | XC08CAN043A001010100002 | NHSA |
| 北京嘉林药业股份有限公司 | 国药准字H20054248 | 20mg | Category A (甲) | XC08CAN043A001010100056 | NHSA |
| 广东华南药业集团有限公司 | 国药准字H44025019 | 20mg | Category A (甲) | XC08CAN043A001010100290 | NHSA |
| 广东隆信制药有限公司 | 国药准字H19999062 | 20mg | Category A (甲) | XC08CAN043A001010100296 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H44020869 | 20mg | Category A (甲) | XC08CAN043A001010100453 | NHSA |
| 上海新亚药业闵行有限公司 | 国药准字H20003605 | 20mg | Category A (甲) | XC08CAN043A001010100795 | NHSA |
| 上海信谊天平药业有限公司 | 国药准字H31022719 | 20mg | Category A (甲) | XC08CAN043A001010100800 | NHSA |
| 天津市中央药业有限公司 | 国药准字H10910040 | 20mg | Category A (甲) | XC08CAN043A001010100928 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H50020378 | 20mg | Category A (甲) | XC08CAN043A001010101016 | NHSA |
| 江苏聚荣制药集团有限公司 | 国药准字H19993420 | 20mg | Category A (甲) | XC08CAN043A001010101460 | NHSA |
| 四川豪运药业股份有限公司 | 国药准字H19993607 | 20mg | Category A (甲) | XC08CAN043A001010102182 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H10983188 | 20mg | Category A (甲) | XC08CAN043A001010102292 | NHSA |
| 西安博爱制药有限责任公司 | 国药准字H61020545 | 20mg | Category A (甲) | XC08CAN043A001010102460 | NHSA |
| 乐声药业石家庄有限公司 | 国药准字H13022049 | 20mg | Category A (甲) | XC08CAN043A001010102680 | NHSA |
| 河北永丰药业有限公司 | 国药准字H13021882 | 20mg | Category A (甲) | XC08CAN043A001010102683 | NHSA |
| 河北天致药业有限公司 | 国药准字H13022559 | 20mg | Category A (甲) | XC08CAN043A001010102783 | NHSA |
| 晋城海斯制药有限公司 | 国药准字H14024117 | 20mg | Category A (甲) | XC08CAN043A001010102856 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H14022821 | 20mg | Category A (甲) | XC08CAN043A001010102959 | NHSA |
| 开封制药(集团)有限公司 | 国药准字H20068100 | 20mg | Category A (甲) | XC08CAN043A001010103139 | NHSA |
| 国药集团容生制药有限公司 | 国药准字H20103620 | 20mg | Category A (甲) | XC08CAN043A001010103205 | NHSA |
| 郑州瑞康制药有限公司 | 国药准字H41022175 | 20mg | Category A (甲) | XC08CAN043A001010103261 | NHSA |
| 河南永和制药有限公司 | 国药准字H41023238 | 20mg | Category A (甲) | XC08CAN043A001010103271 | NHSA |
| 长春雷允上药业有限公司 | 国药准字H22021550 | 30mg | Category A (甲) | XC08CAN043A001010103310 | NHSA |
| 哈尔滨莱博通药业有限公司 | 国药准字H20013328 | 20mg | Category A (甲) | XC08CAN043A001010103620 | NHSA |
| 哈尔滨三联药业股份有限公司 | 国药准字H20255229 | 30mg | Category A (甲) | XC08CAN043A001010103662 | NHSA |
| 迪沙药业集团有限公司 | 国药准字H20123051 | 20mg | Category A (甲) | XC08CAN043A001010103944 | NHSA |
| 山东明仁福瑞达制药股份有限公司 | 国药准字H37022797 | 20mg | Category A (甲) | XC08CAN043A001010103965 | NHSA |
| 北京京丰制药(山东)有限公司 | 国药准字H37022779 | 20mg | Category A (甲) | XC08CAN043A001010104105 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20044983 | 20mg | Category A (甲) | XC08CAN043A001010104131 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H10910080 | 20mg | Category A (甲) | XC08CAN043A001010104187 | NHSA |
| 宁波大红鹰药业股份有限公司 | 国药准字H33020540 | 20mg | Category A (甲) | XC08CAN043A001010104554 | NHSA |
| 深圳市新泰医药有限公司 | 国药准字H43020645 | 30mg | Category A (甲) | XC08CAN043A001010104906 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H20265033 | 30mg | Category A (甲) | XC08CAN043A001010104948 | NHSA |
| 昆明源瑞制药有限公司 | 国药准字H20003311 | 20mg | Category A (甲) | XC08CAN043A001010105611 | NHSA |
| Bayer Vital GmbH | H20130606 | 30mg | Category A (甲) | XC08CAN043A001010178271 | NHSA |
| 上海新亚药业闵行有限公司 | 国药准字H20003605 | 20mg | Category A (甲) | XC08CAN043A001010200795 | NHSA |
| 天津市中央药业有限公司 | 国药准字H10910040 | 20mg | Category A (甲) | XC08CAN043A001010200928 | NHSA |
| 西安博爱制药有限责任公司 | 国药准字H61020545 | 20mg | Category A (甲) | XC08CAN043A001010202460 | NHSA |
| 亚宝药业集团股份有限公司 | 国药准字H14022821 | 20mg | Category A (甲) | XC08CAN043A001010202959 | NHSA |
| 郑州瑞康制药有限公司 | 国药准字H41022175 | 20mg | Category A (甲) | XC08CAN043A001010203261 | NHSA |
| 长春雷允上药业有限公司 | 国药准字H22021550 | 30mg | Category A (甲) | XC08CAN043A001010203310 | NHSA |
| 哈尔滨莱博通药业有限公司 | 国药准字H20013328 | 20mg | Category A (甲) | XC08CAN043A001010203620 | NHSA |
| 哈尔滨三联药业股份有限公司 | 国药准字H20255229 | 30mg | Category A (甲) | XC08CAN043A001010203662 | NHSA |
| 北京京丰制药(山东)有限公司 | 国药准字H37022779 | 20mg | Category A (甲) | XC08CAN043A001010204105 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20044983 | 20mg | Category A (甲) | XC08CAN043A001010204131 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H10910080 | 20mg | Category A (甲) | XC08CAN043A001010204187 | NHSA |
| 哈尔滨三联药业股份有限公司 | 国药准字H20255229 | 30mg | Category A (甲) | XC08CAN043A001010303662 | NHSA |
| 北京京丰制药(山东)有限公司 | 国药准字H37022779 | 20mg | Category A (甲) | XC08CAN043A001010304105 | NHSA |
| 山东鲁抗医药集团赛特有限责任公司 | 国药准字H20044983 | 20mg | Category A (甲) | XC08CAN043A001010304131 | NHSA |
| 丽珠集团丽珠制药厂 | 国药准字H44020870 | 30mg | Category A (甲) | XC08CAN043A001020100453 | NHSA |
| 天津市中央药业有限公司 | 国药准字H20043915 | 30mg | Category A (甲) | XC08CAN043A001020100928 | NHSA |
| 河南永和制药有限公司 | 国药准字H41023237 | 30mg | Category A (甲) | XC08CAN043A001020103271 | NHSA |
| 山东明仁福瑞达制药股份有限公司 | 国药准字H37022796 | 30mg | Category A (甲) | XC08CAN043A001020103965 | NHSA |
| 北京京丰制药(山东)有限公司 | 国药准字H37022778 | 30mg | Category A (甲) | XC08CAN043A001020104105 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H10910081 | 30mg | Category A (甲) | XC08CAN043A001020104187 | NHSA |
| 北京京丰制药(山东)有限公司 | 国药准字H37022778 | 30mg | Category A (甲) | XC08CAN043A001020204105 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H10910081 | 30mg | Category A (甲) | XC08CAN043A001020204187 | NHSA |
| 上海世康特制药有限公司 | 国药准字H10960134 | 30mg | Category A (甲) | XC08CAN043A017010100760 | NHSA |
| 哈尔滨莱博通药业有限公司 | 国药准字H20013329 | 30mg | Category A (甲) | XC08CAN043A017010103620 | NHSA |
| 上海世康特制药有限公司 | 国药准字H10960134 | 30mg | Category A (甲) | XC08CAN043A017010200760 | NHSA |
| 哈尔滨莱博通药业有限公司 | 国药准字H20013329 | 30mg | Category A (甲) | XC08CAN043A017010203620 | NHSA |
| 哈尔滨莱博通药业有限公司 | 国药准字H20013329 | 30mg | Category A (甲) | XC08CAN043A017010303620 | NHSA |
| 哈药集团三精明水药业有限公司 | 国药准字H20067128 | 30mg | Category A (甲) | XC08CAN043A025010103702 | NHSA |
| 哈药集团三精明水药业有限公司 | 国药准字H23021402 | 20mg | Category A (甲) | XC08CAN043A025020103702 | 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.
Loaded records: 3 filings and 3 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 烟台鲁银药业有限公司 | CYHS2600927 | Generic | 2026/04/23 | Not stated by source | CDE |
| 北京亚宝生物药业有限公司;亚宝药业集团股份有限公司 | CYHS2600886 | Generic | 2026/04/17 | Not stated by source | CDE |
| 石家庄四药有限公司 | CYHS2500573 | Generic | 2025/02/06 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
Non-component matches: 11 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 尼莫地平 | UNION QUIMICO FARMACEUTICA, S.A. | Y20250000153 | I | Exact ingredient | 2025/06/20 | CDE |
| 尼莫地平 | 河北广祥制药有限公司 | Y20230001169 | A | Exact ingredient | 2026/11/08 | CDE |
| 尼莫地平 | 江苏九旭药业有限公司 | Y20210000068 | A | Exact ingredient | 2025/10/11 | CDE |
| 尼莫地平(预制颗粒) | Bayer Vital GmbH | Y20200001505 | A | Exact ingredient | 2025/12/05 | CDE |
| 尼莫地平 | 山东新华制药股份有限公司 | Y20190009425 | A | Exact ingredient | 2025/02/13 | CDE |
| 尼莫地平 | 天津市中央药业有限公司 | Y20190008603 | A | Exact ingredient | 2025/06/28 | CDE |
| 尼莫地平 | 乐声药业石家庄有限公司 | Y20190005094 | A | Exact ingredient | 2024/12/10 | CDE |
| 尼莫地平 | 西安博爱制药有限责任公司 | Y20190004836 | A | Exact ingredient | 2025/07/28 | CDE |
| 尼莫地平 | 河南科伦药业有限公司 | Y20190004746 | A | Exact ingredient | 2024/11/01 | CDE |
| 尼莫地平 | 亚宝药业集团股份有限公司 | Y20190004586 | A | Exact ingredient | 2026/03/31 | CDE |
| 尼莫地平 | 北京京丰制药(山东)有限公司 | Y20190001823 | A | Exact ingredient | 2025/11/12 | CDE |
| 尼莫地平 | 郑州瑞康制药有限公司 | Y20190001753 | A | Exact ingredient | 2024/11/01 | CDE |
| 尼莫地平(预制颗粒) | Bayer Vital GmbH | Y20190000282 | I | Exact ingredient | 2019/08/12 | CDE |
| 尼莫地平 | 山东新华制药股份有限公司 | Y20180001435 | I | Exact ingredient | 2018/11/13 | 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.
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.
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.
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.
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.
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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