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As of 13 November 2026, for Lercanidipine Hydrochloride Tablets, 6 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 6 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 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 holders6View records ↓
Under-review filings6View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers9View records ↓
API companies with A status7View records ↓
Chemical-drug catalogue
Loaded records: 6 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20249816 | 2024/12/25 | 10mg | Not stated by source | CDE |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized | 国药准字H20243083 | 2024/01/23 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20227008 | 2022/01/20 | 20mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20103398 | 2022/01/20 | 10mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Anhui Hong Ye Pharma Co., Ltd. romanized | Anhui Hong Ye Pharma Co., Ltd. romanized | 国药准字H20213023 | 2021/01/12 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 国药准字H20203270 | 2020/06/17 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Recordati S.P.A. | Recordati S.P.A. | H20160258;H20160269 | 2001/11/06 | 10mg | 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: 9 distinct approval numbers and 6 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 国药准字H20203270 | 10mg | Category B | XC08CAL042A001010100553 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20103398 | 10mg | Category B | XC08CAL042A001010101034 | NHSA |
| Anhui Hong Ye Pharma Co., Ltd. romanized | 国药准字H20213023 | 10mg | Category B | XC08CAL042A001010104373 | NHSA |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20243083 | 10mg | Category B | XC08CAL042A001010104561 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20227008 | 20mg | Category B | XC08CAL042A001010109568 | NHSA |
| Recordati S.P.A. | 国药准字HJ20160258 | 10mg | Category B | XC08CAL042A001010179340 | NHSA |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249816 | 10mg | Category B | XC08CAL042A001010184135 | NHSA |
| Shenzhen Xin Li Tai Pharma Co., Ltd. romanized | 国药准字H20203270 | 10mg | Category B | XC08CAL042A001010200553 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20103398 | 10mg | Category B | XC08CAL042A001010201034 | NHSA |
| Anhui Hong Ye Pharma Co., Ltd. romanized | 国药准字H20213023 | 10mg | Category B | XC08CAL042A001010204373 | NHSA |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20243083 | 10mg | Category B | XC08CAL042A001010204561 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20227008 | 20mg | Category B | XC08CAL042A001010209568 | NHSA |
| Recordati S.P.A. | 国药准字HJ20160258 | 10mg | Category B | XC08CAL042A001010279340 | NHSA |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249816 | 10mg | Category B | XC08CAL042A001010284135 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20103398 | 10mg | Category B | XC08CAL042A001010301034 | NHSA |
| Anhui Hong Ye Pharma Co., Ltd. romanized | 国药准字H20213023 | 10mg | Category B | XC08CAL042A001010304373 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20227008 | 20mg | Category B | XC08CAL042A001010309568 | NHSA |
| Recordati S.P.A. | H20160269 | 10mg | Category B | XC08CAL042A001010379340 | NHSA |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20249816 | 10mg | Category B | XC08CAL042A001010384135 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20103398 | 10mg | Category B | XC08CAL042A001010401034 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20227008 | 20mg | Category B | XC08CAL042A001010409568 | NHSA |
| Recordati S.P.A. | H20160269 | 10mg | Category B | XC08CAL042A001010479340 | NHSA |
| Recordati S.P.A. | 国药准字HJ20160257 | 20mg | Category B | XC08CAL042A001020179340 | NHSA |
| Recordati S.P.A. | 国药准字HJ20160257 | 20mg | Category B | XC08CAL042A001020279340 | 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: 6 filings and 5 distinct first applicants.
Generic 6
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized | CYHS2602549 | Generic | 2026/10/16 | Not stated by source | CDE |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | CYHS2600050 | Generic | 2026/01/06 | Not stated by source | CDE |
| Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized | CYHS2503620 | Generic | 2025/10/10 | Not stated by source | CDE |
| Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanized | CYHS2503619 | Generic | 2025/10/10 | Not stated by source | CDE |
| Shenyang Tian Bang Pharma Co., Ltd. romanized | CYHS2503577 | Generic | 2025/09/30 | Not stated by source | CDE |
| Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | CYHS2502840 | Generic | 2025/08/06 | 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 |
|---|---|---|---|---|---|
| Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized | CYHS2602549 | Generic | 2026/10/16 | Not stated by source | CDE |
| Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized | CYHS2600050 | Generic | 2026/01/06 | Not stated by source | CDE |
API registrations
Non-component matches: 7 companies with A status and 6 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 盐酸乐卡地平 · No verified English name | SUN PHARMACEUTICAL INDUSTRIES LTD | Y20220001090 | I | Exact ingredient | 2024/08/08 | CDE |
| 盐酸乐卡地平 · No verified English name | Fu An Pharma Group Chongqing Bo Sheng Pharmaceutical Co., Ltd. romanized | Y20200000966 | A | Exact ingredient | 2026/10/26 | CDE |
| 盐酸乐卡地平 · No verified English name | Glenmark Life Sciences Limited | Y20190009049 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸乐卡地平 · No verified English name | Glenmark Life Sciences Limited | Y20190009048 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸乐卡地平 · No verified English name | Glenmark Life Sciences Limited | Y20190009047 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸乐卡地平 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20190003920 | A | Exact ingredient | 2026/01/09 | CDE |
| 盐酸乐卡地平 · No verified English name | Hui Zhou Xin Li Tai Pharma Co., Ltd. romanized | Y20180001486 | A | Exact ingredient | 2026/01/23 | CDE |
| 盐酸乐卡地平 · No verified English name | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Y20170001301 | A | Exact ingredient | 2024/04/29 | CDE |
| 盐酸乐卡地平 · No verified English name | Shenyang Tian Bang Pharma Co., Ltd. romanized | Y20170001087 | A | Exact ingredient | 2022/10/31 | CDE |
| 盐酸乐卡地平 · No verified English name | Hebei Yi Pin Pharmaceutical Co., Ltd. romanized | Y20170000907 | I | Exact ingredient | — | CDE |
| 盐酸乐卡地平 · No verified English name | Tianjin Zhong Rui Pharma Co., Ltd. romanized | Y20170000791 | I | Exact ingredient | — | CDE |
| 盐酸乐卡地平 · No verified English name | Xing An Pharma Co., Ltd. romanized | Y20170000543 | I | Exact ingredient | — | CDE |
| 盐酸乐卡地平 · No verified English name | Suzhou Erye Pharmaceutical Co., Ltd | Y20170000468 | I | Exact ingredient | — | CDE |
| 盐酸乐卡地平 · No verified English name | Shenzhen Wo Lan De Pharma Co., Ltd. romanized | Y20170000118 | I | Exact ingredient | — | CDE |
| 盐酸乐卡地平 · No verified English name | Anhui Heng Xing Pharmaceutical Co., Ltd. romanized | Y20170000091 | A | Exact ingredient | 2024/05/15 | 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.
-
2026/10/16Accepted
Chongqing Hua Sen Pharmaceutical Co., Ltd. romanized
CYHS2602549
Fact date: 2026/10/16 · Site observation date: 2026/10/22
View source ↗
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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