Monthly
US$200
Billed every month
Tacrolimus Sustained-release Capsules(他克莫司缓释胶囊)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 applications
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 holders9View records ↓
Under-review filings6View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers22View records ↓
API companies with A status12View records ↓
Chemical-drug catalogue
Loaded records: 9 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 9 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 |
|---|---|---|---|---|---|---|
| 上海安必生制药技术有限公司 | 吉林四环制药有限公司 | 国药准字H20264058 | 2026/04/21 | 0.5mg | 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 |
| 上海安必生制药技术有限公司 | 吉林四环制药有限公司 | 国药准字H20264057 | 2026/04/21 | 1mg | 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 |
| 江苏和晨药业有限公司 | 江苏和晨药业有限公司 | 国药准字H20269058 | 2026/03/19 | 0.5mg | 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 |
| 石药集团中诺药业（石家庄）有限公司 | 石药集团中诺药业（石家庄）有限公司 | 国药准字H20255647 | 2025/09/30 | 0.5mg | 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 |
| 石药集团中诺药业（石家庄）有限公司 | 石药集团中诺药业（石家庄）有限公司 | 国药准字H20255646 | 2025/09/30 | 1mg | 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 |
| 江苏和晨药业有限公司 | 江苏和晨药业有限公司 | 国药准字H20254680 | 2025/06/30 | 1mg | 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 |
| 海南合瑞制药股份有限公司 | 海南合瑞制药股份有限公司 | 国药准字H20253557 | 2025/03/04 | 0.5mg | 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 |
| 海南合瑞制药股份有限公司 | 海南合瑞制药股份有限公司 | 国药准字H20253556 | 2025/03/04 | 1mg | 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 |
| 辰欣药业股份有限公司 | 华益泰康药业股份有限公司 | 国药准字H20253242 | 2025/01/24 | 1mg | 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 |
| 辰欣药业股份有限公司 | 华益泰康药业股份有限公司 | 国药准字H20253241 | 2025/01/24 | 0.5mg | 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 |
| 湖南科伦制药有限公司 | 湖南科伦制药有限公司 | 国药准字H20253165 | 2025/01/14 | 1mg | 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 |
| 湖南科伦制药有限公司 | 湖南科伦制药有限公司 | 国药准字H20253166 | 2025/01/14 | 0.5mg | 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 |
| 杭州中美华东制药有限公司 | 杭州中美华东制药江东有限公司 | 国药准字H20244137 | 2024/06/25 | 1mg | 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 |
| 杭州中美华东制药江东有限公司 | 杭州中美华东制药江东有限公司 | 国药准字H20244136 | 2024/06/25 | 0.5mg | 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 |
| 杭州中美华东制药有限公司 | 杭州中美华东江东制药有限公司 | 国药准字H20243200 | 2024/02/23 | 5mg | 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 |
| 成都盛迪医药有限公司 | 成都盛迪医药有限公司 | 国药准字H20223424 | 2022/06/28 | 0.5mg | 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 |
| 成都盛迪医药有限公司 | 成都盛迪医药有限公司 | 国药准字H20223422 | 2022/06/28 | 5mg | 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 |
| 成都盛迪医药有限公司 | 成都盛迪医药有限公司 | 国药准字H20223423 | 2022/06/28 | 1mg | 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 |
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: 22 distinct approval numbers and 9 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Astellas Pharma Europe B.V. | 国药准字J20150055 | 0.5mg | Category B (乙) | XL04ADT002E003010101076 | NHSA |
| 石药集团中诺药业(石家庄)有限公司 | 国药准字H20255646 | 1mg | Category B (乙) | XL04ADT002E003010102777 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20253241 | 0.5mg | Category B (乙) | XL04ADT002E003010104127 | NHSA |
| 杭州中美华东制药有限公司 | 国药准字H20244136 | 0.5mg | Category B (乙) | XL04ADT002E003010104520 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H20253165 | 1mg | Category B (乙) | XL04ADT002E003010104948 | NHSA |
| 海南合瑞制药股份有限公司 | 国药准字H20253557 | 0.5mg | Category B (乙) | XL04ADT002E003010105815 | NHSA |
| 成都盛迪医药有限公司 | 国药准字H20223424 | 0.5mg | Category B (乙) | XL04ADT002E003010180435 | NHSA |
| 上海安必生制药技术有限公司 | 国药准字H20264057 | 1mg | Category B (乙) | XL04ADT002E003010182990 | NHSA |
| 杭州中美华东制药有限公司 | 国药准字H20243200 | 5mg | Category B (乙) | XL04ADT002E003010183516 | NHSA |
| 江苏和晨药业有限公司 | 国药准字H20254680 | 1mg | Category B (乙) | XL04ADT002E003010183879 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20253241 | 0.5mg | Category B (乙) | XL04ADT002E003010204127 | NHSA |
| 海南合瑞制药股份有限公司 | 国药准字H20253557 | 0.5mg | Category B (乙) | XL04ADT002E003010205815 | NHSA |
| Astellas Pharma Europe B.V. | 国药准字HJ20150029 | 0.5mg | Category B (乙) | XL04ADT002E003010279406 | NHSA |
| Astellas Pharma Europe B.V. | 国药准字J20150056 | 1mg | Category B (乙) | XL04ADT002E003020101076 | NHSA |
| 石药集团中诺药业(石家庄)有限公司 | 国药准字H20255647 | 0.5mg | Category B (乙) | XL04ADT002E003020102777 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20253242 | 1mg | Category B (乙) | XL04ADT002E003020104127 | NHSA |
| 杭州中美华东制药有限公司 | 国药准字H20244137 | 1mg | Category B (乙) | XL04ADT002E003020104520 | NHSA |
| 湖南科伦制药有限公司 | 国药准字H20253166 | 0.5mg | Category B (乙) | XL04ADT002E003020104948 | NHSA |
| 海南合瑞制药股份有限公司 | 国药准字H20253556 | 1mg | Category B (乙) | XL04ADT002E003020105815 | NHSA |
| 成都盛迪医药有限公司 | 国药准字H20223423 | 1mg | Category B (乙) | XL04ADT002E003020180435 | NHSA |
| 上海安必生制药技术有限公司 | 国药准字H20264058 | 0.5mg | Category B (乙) | XL04ADT002E003020182990 | NHSA |
| 江苏和晨药业有限公司 | 国药准字H20269058 | 0.5mg | Category B (乙) | XL04ADT002E003020183879 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20253242 | 1mg | Category B (乙) | XL04ADT002E003020204127 | NHSA |
| 海南合瑞制药股份有限公司 | 国药准字H20253556 | 1mg | Category B (乙) | XL04ADT002E003020205815 | NHSA |
| Astellas Pharma Europe B.V. | 国药准字HJ20150031 | 1mg | Category B (乙) | XL04ADT002E003020279406 | NHSA |
| 成都盛迪医药有限公司 | 国药准字H20223422 | 5mg | Category B (乙) | XL04ADT002E003030180435 | 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 3 distinct first applicants.
Generic 6
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 国药集团川抗制药有限公司 | CYHS2602572 | Generic | 2026/10/19 | Not stated by source | CDE |
| 国药集团川抗制药有限公司 | CYHS2602571 | Generic | 2026/10/19 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2601292 | Generic | 2026/06/04 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2601291 | Generic | 2026/06/04 | Not stated by source | CDE |
| 合肥力成药业有限公司 | CYHS2600740 | Generic | 2026/03/27 | Not stated by source | CDE |
| 合肥力成药业有限公司 | CYHS2600739 | Generic | 2026/03/27 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 6 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 国药集团川抗制药有限公司 | CYHS2602572 | Generic | 2026/10/19 | Not stated by source | CDE |
| 国药集团川抗制药有限公司 | CYHS2602571 | Generic | 2026/10/19 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2601292 | Generic | 2026/06/04 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2601291 | Generic | 2026/06/04 | Not stated by source | CDE |
| 合肥力成药业有限公司 | CYHS2600740 | Generic | 2026/03/27 | Not stated by source | CDE |
| 合肥力成药业有限公司 | CYHS2600739 | Generic | 2026/03/27 | Not stated by source | CDE |
API registrations
Non-component matches: 12 companies with A status and 8 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 |
|---|---|---|---|---|---|---|
| 他克莫司 | 浙江海翔药业股份有限公司 | Y20250000882 | I | Exact ingredient | 2025/09/02 | CDE |
| 他克莫司 | Bills Biotech Pvt. Ltd. | Y20240000691 | I | Exact ingredient | 2024/10/10 | CDE |
| 他克莫司 | 四川诺宜生药业有限公司 | Y20240000730 | A | Exact ingredient | 2025/12/17 | CDE |
| 他克莫司 | 中化合成生技股份有限公司山佳工厰 | Y20240000073 | I | Exact ingredient | 2024/07/16 | CDE |
| 他克莫司 | Biocon Biosphere Limited | Y20240000135 | A | Exact ingredient | 2026/06/01 | CDE |
| 他克莫司 | 鲁南新时代生物技术有限公司 | Y20230001120 | A | Exact ingredient | 2026/05/20 | CDE |
| 他克莫司 | Biocon Limited | Y20220000745 | A | Exact ingredient | 2024/12/13 | CDE |
| 他克莫司 | 无锡福祈制药有限公司 | Y20210000983 | A | Exact ingredient | 2024/04/13 | CDE |
| 他克莫司 | CERES F&D Incorporated | Y20210000344 | I | Exact ingredient | 2021/07/12 | CDE |
| 他克莫司 | Concord Biotech Limited | Y20210000143 | I | Exact ingredient | 2025/12/30 | CDE |
| 他克莫司 | 江苏九阳生物制药有限公司 | Y20210000274 | A | Exact ingredient | 2026/06/13 | CDE |
| 他克莫司 | Astellas Pharma Inc. | Y20190000843 | I | Exact ingredient | 2020/03/09 | CDE |
| 他克莫司 | 杭州中美华东制药有限公司 | Y20190009352 | A | Exact ingredient | — | CDE |
| 他克莫司 | 福建科瑞药业有限公司 | Y20190008905 | A | Exact ingredient | 2025/03/06 | CDE |
| 他克莫司 | 国药集团川抗制药有限公司 | Y20190006989 | A | Exact ingredient | 2026/06/29 | CDE |
| 他克莫司 | 华北制药华胜有限公司 | Y20190006104 | A | Exact ingredient | 2025/08/08 | CDE |
| 他克莫司 | 海正药业（杭州）有限公司 | Y20190006081 | A | Exact ingredient | 2025/07/18 | CDE |
| 他克莫司 | 杭州中美华东制药有限公司 | Y20170001979 | A | Exact ingredient | 2023/03/24 | CDE |
| 他克莫司 | TAPI Czech Industries s.r.o. | Y20170000349 | A | Exact ingredient | 2025/05/08 | CDE |
| 他克莫司 | 山东新时代药业有限公司 | Y20170000052 | I | Exact ingredient | — | CDE |
| 他克莫司 | Biocon Limited | Y20170000011 | I | Exact ingredient | — | 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.
-
2026/10/19Accepted
-
2026/10/19Accepted
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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