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Lercanidipine Hydrochloride Tablets(盐酸乐卡地平片)
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.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
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 |
|---|---|---|---|---|---|---|
| 杭州沐源生物医药科技有限公司 | 新乡市常乐制药有限责任公司 | 国药准字H20249816 | 2024/12/25 | 10mg | Not stated by source | CDE |
| 福安药业集团宁波天衡制药有限公司 | 福安药业集团庆余堂制药有限公司 | 国药准字H20243083 | 2024/01/23 | 10mg | 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 |
| 重庆圣华曦药业股份有限公司 | 重庆圣华曦药业股份有限公司 | 国药准字H20227008 | 2022/01/20 | 20mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 重庆圣华曦药业股份有限公司 | 重庆圣华曦药业股份有限公司 | 国药准字H20103398 | 2022/01/20 | 10mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 安徽宏业药业有限公司 | 安徽宏业药业有限公司 | 国药准字H20213023 | 2021/01/12 | 10mg | 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 |
| 深圳信立泰药业股份有限公司 | 深圳信立泰药业股份有限公司 | 国药准字H20203270 | 2020/06/17 | 10mg | 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 |
| Recordati S.P.A. | Recordati S.P.A. | H20160258;H20160269 | 2001/11/06 | 10mg | 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: 9 distinct approval numbers and 6 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 深圳信立泰药业股份有限公司 | 国药准字H20203270 | 10mg | Category B (乙) | XC08CAL042A001010100553 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20103398 | 10mg | Category B (乙) | XC08CAL042A001010101034 | NHSA |
| 安徽宏业药业有限公司 | 国药准字H20213023 | 10mg | Category B (乙) | XC08CAL042A001010104373 | NHSA |
| 福安药业集团宁波天衡制药有限公司 | 国药准字H20243083 | 10mg | Category B (乙) | XC08CAL042A001010104561 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20227008 | 20mg | Category B (乙) | XC08CAL042A001010109568 | NHSA |
| Recordati S.P.A. | 国药准字HJ20160258 | 10mg | Category B (乙) | XC08CAL042A001010179340 | NHSA |
| 杭州沐源生物医药科技股份有限公司 | 国药准字H20249816 | 10mg | Category B (乙) | XC08CAL042A001010184135 | NHSA |
| 深圳信立泰药业股份有限公司 | 国药准字H20203270 | 10mg | Category B (乙) | XC08CAL042A001010200553 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20103398 | 10mg | Category B (乙) | XC08CAL042A001010201034 | NHSA |
| 安徽宏业药业有限公司 | 国药准字H20213023 | 10mg | Category B (乙) | XC08CAL042A001010204373 | NHSA |
| 福安药业集团宁波天衡制药有限公司 | 国药准字H20243083 | 10mg | Category B (乙) | XC08CAL042A001010204561 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20227008 | 20mg | Category B (乙) | XC08CAL042A001010209568 | NHSA |
| Recordati S.P.A. | 国药准字HJ20160258 | 10mg | Category B (乙) | XC08CAL042A001010279340 | NHSA |
| 杭州沐源生物医药科技股份有限公司 | 国药准字H20249816 | 10mg | Category B (乙) | XC08CAL042A001010284135 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20103398 | 10mg | Category B (乙) | XC08CAL042A001010301034 | NHSA |
| 安徽宏业药业有限公司 | 国药准字H20213023 | 10mg | Category B (乙) | XC08CAL042A001010304373 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20227008 | 20mg | Category B (乙) | XC08CAL042A001010309568 | NHSA |
| Recordati S.P.A. | H20160269 | 10mg | Category B (乙) | XC08CAL042A001010379340 | NHSA |
| 杭州沐源生物医药科技股份有限公司 | 国药准字H20249816 | 10mg | Category B (乙) | XC08CAL042A001010384135 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20103398 | 10mg | Category B (乙) | XC08CAL042A001010401034 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20227008 | 20mg | Category B (乙) | XC08CAL042A001010409568 | NHSA |
| Recordati S.P.A. | H20160269 | 10mg | Category B (乙) | XC08CAL042A001010479340 | NHSA |
| Recordati S.P.A. | 国药准字HJ20160257 | 20mg | Category B (乙) | XC08CAL042A001020179340 | NHSA |
| Recordati S.P.A. | 国药准字HJ20160257 | 20mg | Category B (乙) | 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 |
|---|---|---|---|---|---|
| 重庆华森制药股份有限公司 | CYHS2602549 | Generic | 2026/10/16 | Not stated by source | CDE |
| 福建海西新药创制股份有限公司 | CYHS2600050 | Generic | 2026/01/06 | Not stated by source | CDE |
| 吉林天衡英睿制药有限公司 | CYHS2503620 | Generic | 2025/10/10 | Not stated by source | CDE |
| 吉林天衡英睿制药有限公司 | CYHS2503619 | Generic | 2025/10/10 | Not stated by source | CDE |
| 沈阳天邦药业有限公司 | CYHS2503577 | Generic | 2025/09/30 | Not stated by source | CDE |
| 福建省宝诺医药研发有限公司;石家庄市华新药业有限责任公司 | CYHS2502840 | Generic | 2025/08/06 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
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 | SUN PHARMACEUTICAL INDUSTRIES LTD | Y20220001090 | I | Exact ingredient | 2024/08/08 | CDE |
| 盐酸乐卡地平 | 福安药业集团重庆博圣制药有限公司 | Y20200000966 | A | Exact ingredient | 2026/10/26 | CDE |
| 盐酸乐卡地平 | Glenmark Life Sciences Limited | Y20190009049 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸乐卡地平 | Glenmark Life Sciences Limited | Y20190009048 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸乐卡地平 | Glenmark Life Sciences Limited | Y20190009047 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸乐卡地平 | 重庆圣华曦药业股份有限公司 | Y20190003920 | A | Exact ingredient | 2026/01/09 | CDE |
| 盐酸乐卡地平 | 惠州信立泰药业有限公司 | Y20180001486 | A | Exact ingredient | 2026/01/23 | CDE |
| 盐酸乐卡地平 | 天地恒一制药股份有限公司 | Y20170001301 | A | Exact ingredient | 2024/04/29 | CDE |
| 盐酸乐卡地平 | 沈阳天邦药业有限公司 | Y20170001087 | A | Exact ingredient | 2022/10/31 | CDE |
| 盐酸乐卡地平 | 河北一品制药股份有限公司 | Y20170000907 | I | Exact ingredient | — | CDE |
| 盐酸乐卡地平 | 天津中瑞药业有限公司 | Y20170000791 | I | Exact ingredient | — | CDE |
| 盐酸乐卡地平 | 兴安药业有限公司 | Y20170000543 | I | Exact ingredient | — | CDE |
| 盐酸乐卡地平 | 苏州二叶制药有限公司 | Y20170000468 | I | Exact ingredient | — | CDE |
| 盐酸乐卡地平 | 深圳沃兰德药业有限公司 | Y20170000118 | I | Exact ingredient | — | CDE |
| 盐酸乐卡地平 | 安徽恒星制药有限公司 | 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/10/16Accepted
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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