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As of 13 November 2026, for Nimodipine Tablets, 3 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 5 holders.
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: 2026/11/13 06:42
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 holders5View records ↓
Under-review filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers45View records ↓
API companies with A status11View records ↓
Chemical-drug catalogue
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 |
|---|---|---|---|---|---|---|
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H10910081 | 2026/10/15 | 30mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20265033 | 2026/06/30 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | 国药准字H20255229 | 2025/08/26 | 30mg | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 国药准字H20003010 | 2000/11/02 | 30mg | Other drug | CDE |
| Bayer Vital GmbH | Bayer Pharma AG | H20130606 | 1993/02/05 | 30mg | 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: 45 distinct approval numbers and 37 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized | 国药准字H20003010 | 30mg | Category A | XC08CAN043A001010100002 | NHSA |
| Beijing Jia Lin Pharma Co., Ltd. romanized | 国药准字H20054248 | 20mg | Category A | XC08CAN043A001010100056 | NHSA |
| Guangdong Hua Nan Pharma Group Co., Ltd. romanized | 国药准字H44025019 | 20mg | Category A | XC08CAN043A001010100290 | NHSA |
| Guangdong Long Xin Pharmaceutical Co., Ltd. romanized | 国药准字H19999062 | 20mg | Category A | XC08CAN043A001010100296 | NHSA |
| Li Zhu Group Li Zhu Pharmaceutical Factory romanized | 国药准字H44020869 | 20mg | Category A | XC08CAN043A001010100453 | NHSA |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized | 国药准字H20003605 | 20mg | Category A | XC08CAN043A001010100795 | NHSA |
| Shanghai Xin Yi Tian Ping Pharma Co., Ltd. romanized | 国药准字H31022719 | 20mg | Category A | XC08CAN043A001010100800 | NHSA |
| Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized | 国药准字H10910040 | 20mg | Category A | XC08CAN043A001010100928 | NHSA |
| Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H50020378 | 20mg | Category A | XC08CAN043A001010101016 | NHSA |
| Jiangsu Ju Rong Pharmaceutical Group Co., Ltd. romanized | 国药准字H19993420 | 20mg | Category A | XC08CAN043A001010101460 | NHSA |
| Sichuan Hao Yun Pharma Co., Ltd. romanized | 国药准字H19993607 | 20mg | Category A | XC08CAN043A001010102182 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H10983188 | 20mg | Category A | XC08CAN043A001010102292 | NHSA |
| Xian Bo Ai Pharmaceutical Co., Ltd. romanized | 国药准字H61020545 | 20mg | Category A | XC08CAN043A001010102460 | NHSA |
| Le Sheng Pharma Shijiazhuang Co., Ltd. romanized | 国药准字H13022049 | 20mg | Category A | XC08CAN043A001010102680 | NHSA |
| Hebei Yong Feng Pharma Co., Ltd. romanized | 国药准字H13021882 | 20mg | Category A | XC08CAN043A001010102683 | NHSA |
| Hebei Tian Zhi Pharma Co., Ltd. romanized | 国药准字H13022559 | 20mg | Category A | XC08CAN043A001010102783 | NHSA |
| Jin Cheng Hai Si Pharmaceutical Co., Ltd. romanized | 国药准字H14024117 | 20mg | Category A | XC08CAN043A001010102856 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H14022821 | 20mg | Category A | XC08CAN043A001010102959 | NHSA |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H20068100 | 20mg | Category A | XC08CAN043A001010103139 | NHSA |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20103620 | 20mg | Category A | XC08CAN043A001010103205 | NHSA |
| Zhengzhou Rui Kang Pharmaceutical Co., Ltd. romanized | 国药准字H41022175 | 20mg | Category A | XC08CAN043A001010103261 | NHSA |
| Henan Yong He Pharmaceutical Co., Ltd. romanized | 国药准字H41023238 | 20mg | Category A | XC08CAN043A001010103271 | NHSA |
| Changchun Lei Yun Shang Pharma Co., Ltd. romanized | 国药准字H22021550 | 30mg | Category A | XC08CAN043A001010103310 | NHSA |
| Haerbin Lai Bo Tong Pharma Co., Ltd. romanized | 国药准字H20013328 | 20mg | Category A | XC08CAN043A001010103620 | NHSA |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20255229 | 30mg | Category A | XC08CAN043A001010103662 | NHSA |
| Di Sha Pharma Group Co., Ltd. romanized | 国药准字H20123051 | 20mg | Category A | XC08CAN043A001010103944 | NHSA |
| Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized | 国药准字H37022797 | 20mg | Category A | XC08CAN043A001010103965 | NHSA |
| Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized | 国药准字H37022779 | 20mg | Category A | XC08CAN043A001010104105 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20044983 | 20mg | Category A | XC08CAN043A001010104131 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H10910080 | 20mg | Category A | XC08CAN043A001010104187 | NHSA |
| Ningbo Da Hong Ying Pharma Co., Ltd. romanized | 国药准字H33020540 | 20mg | Category A | XC08CAN043A001010104554 | NHSA |
| Shenzhen Shi Xin Tai Pharmaceuticals Co., Ltd. romanized | 国药准字H43020645 | 30mg | Category A | XC08CAN043A001010104906 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20265033 | 30mg | Category A | XC08CAN043A001010104948 | NHSA |
| Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20003311 | 20mg | Category A | XC08CAN043A001010105611 | NHSA |
| Bayer Vital GmbH | H20130606 | 30mg | Category A | XC08CAN043A001010178271 | NHSA |
| Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized | 国药准字H20003605 | 20mg | Category A | XC08CAN043A001010200795 | NHSA |
| Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized | 国药准字H10910040 | 20mg | Category A | XC08CAN043A001010200928 | NHSA |
| Xian Bo Ai Pharmaceutical Co., Ltd. romanized | 国药准字H61020545 | 20mg | Category A | XC08CAN043A001010202460 | NHSA |
| Ya Bao Pharma Group Co., Ltd. romanized | 国药准字H14022821 | 20mg | Category A | XC08CAN043A001010202959 | NHSA |
| Zhengzhou Rui Kang Pharmaceutical Co., Ltd. romanized | 国药准字H41022175 | 20mg | Category A | XC08CAN043A001010203261 | NHSA |
| Changchun Lei Yun Shang Pharma Co., Ltd. romanized | 国药准字H22021550 | 30mg | Category A | XC08CAN043A001010203310 | NHSA |
| Haerbin Lai Bo Tong Pharma Co., Ltd. romanized | 国药准字H20013328 | 20mg | Category A | XC08CAN043A001010203620 | NHSA |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20255229 | 30mg | Category A | XC08CAN043A001010203662 | NHSA |
| Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized | 国药准字H37022779 | 20mg | Category A | XC08CAN043A001010204105 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20044983 | 20mg | Category A | XC08CAN043A001010204131 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H10910080 | 20mg | Category A | XC08CAN043A001010204187 | NHSA |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20255229 | 30mg | Category A | XC08CAN043A001010303662 | NHSA |
| Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized | 国药准字H37022779 | 20mg | Category A | XC08CAN043A001010304105 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20044983 | 20mg | Category A | XC08CAN043A001010304131 | NHSA |
| Li Zhu Group Li Zhu Pharmaceutical Factory romanized | 国药准字H44020870 | 30mg | Category A | XC08CAN043A001020100453 | NHSA |
| Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized | 国药准字H20043915 | 30mg | Category A | XC08CAN043A001020100928 | NHSA |
| Henan Yong He Pharmaceutical Co., Ltd. romanized | 国药准字H41023237 | 30mg | Category A | XC08CAN043A001020103271 | NHSA |
| Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized | 国药准字H37022796 | 30mg | Category A | XC08CAN043A001020103965 | NHSA |
| Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized | 国药准字H37022778 | 30mg | Category A | XC08CAN043A001020104105 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H10910081 | 30mg | Category A | XC08CAN043A001020104187 | NHSA |
| Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized | 国药准字H37022778 | 30mg | Category A | XC08CAN043A001020204105 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H10910081 | 30mg | Category A | XC08CAN043A001020204187 | NHSA |
| Shanghai Shi Kang Te Pharmaceutical Co., Ltd. romanized | 国药准字H10960134 | 30mg | Category A | XC08CAN043A017010100760 | NHSA |
| Haerbin Lai Bo Tong Pharma Co., Ltd. romanized | 国药准字H20013329 | 30mg | Category A | XC08CAN043A017010103620 | NHSA |
| Shanghai Shi Kang Te Pharmaceutical Co., Ltd. romanized | 国药准字H10960134 | 30mg | Category A | XC08CAN043A017010200760 | NHSA |
| Haerbin Lai Bo Tong Pharma Co., Ltd. romanized | 国药准字H20013329 | 30mg | Category A | XC08CAN043A017010203620 | NHSA |
| Haerbin Lai Bo Tong Pharma Co., Ltd. romanized | 国药准字H20013329 | 30mg | Category A | XC08CAN043A017010303620 | NHSA |
| Ha Yao Group San Jing Ming Shui Pharma Co., Ltd. romanized | 国药准字H20067128 | 30mg | Category A | XC08CAN043A025010103702 | NHSA |
| Ha Yao Group San Jing Ming Shui Pharma Co., Ltd. romanized | 国药准字H23021402 | 20mg | Category A | 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.
Current under-review applications
Loaded records: 3 filings and 3 distinct first applicants.
Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600927 | Generic | 2026/04/23 | Not stated by source | CDE |
| Beijing Ya Bao Bio Pharma Co., Ltd. romanized; Ya Bao Pharma Group Co., Ltd. romanized | CYHS2600886 | Generic | 2026/04/17 | Not stated by source | CDE |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | CYHS2500573 | Generic | 2025/02/06 | 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 |
|---|---|---|---|---|---|
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2600927 | Generic | 2026/04/23 | Not stated by source | CDE |
| Beijing Ya Bao Bio Pharma Co., Ltd. romanized; Ya Bao Pharma Group Co., Ltd. romanized | CYHS2600886 | Generic | 2026/04/17 | Not stated by source | CDE |
API registrations
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 · No verified English name | UNION QUIMICO FARMACEUTICA, S.A. | Y20250000153 | I | Exact ingredient | 2025/06/20 | CDE |
| 尼莫地平 · No verified English name | Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20230001169 | A | Exact ingredient | 2026/11/08 | CDE |
| 尼莫地平 · No verified English name | Jiangsu Jiu Xu Pharma Co., Ltd. romanized | Y20210000068 | A | Exact ingredient | 2025/10/11 | CDE |
| 尼莫地平（预制颗粒） · No verified English name | Bayer Vital GmbH | Y20200001505 | A | Exact ingredient | 2025/12/05 | CDE |
| 尼莫地平 · No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20190009425 | A | Exact ingredient | 2025/02/13 | CDE |
| 尼莫地平 · No verified English name | Tianjin Shi Zhong Yang Pharma Co., Ltd. romanized | Y20190008603 | A | Exact ingredient | 2025/06/28 | CDE |
| 尼莫地平 · No verified English name | Le Sheng Pharma Shijiazhuang Co., Ltd. romanized | Y20190005094 | A | Exact ingredient | 2024/12/10 | CDE |
| 尼莫地平 · No verified English name | Xian Bo Ai Pharmaceutical Co., Ltd. romanized | Y20190004836 | A | Exact ingredient | 2025/07/28 | CDE |
| 尼莫地平 · No verified English name | Henan Ke Lun Pharma Co., Ltd. romanized | Y20190004746 | A | Exact ingredient | 2024/11/01 | CDE |
| 尼莫地平 · No verified English name | Ya Bao Pharma Group Co., Ltd. romanized | Y20190004586 | A | Exact ingredient | 2026/03/31 | CDE |
| 尼莫地平 · No verified English name | Beijing Jing Feng Pharmaceutical (Shandong) Co., Ltd. romanized | Y20190001823 | A | Exact ingredient | 2025/11/12 | CDE |
| 尼莫地平 · No verified English name | Zhengzhou Rui Kang Pharmaceutical Co., Ltd. romanized | Y20190001753 | A | Exact ingredient | 2024/11/01 | CDE |
| 尼莫地平（预制颗粒） · No verified English name | Bayer Vital GmbH | Y20190000282 | I | Exact ingredient | 2019/08/12 | CDE |
| 尼莫地平 · No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 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.
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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
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: 2026/11/13 06:41
- 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: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · 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: 13. 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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