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Mycophenolate Mofetil Capsules(吗替麦考酚酯胶囊)
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 holders12View records ↓
Under-review filings4View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers13View records ↓
API companies with A status28View records ↓
Chemical-drug catalogue
Loaded records: 12 holders; 7 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 |
|---|---|---|---|---|---|---|
| Mylan Laboratories Limited | Mylan Laboratories Limited | 国药准字HJ20250098 | 2025/08/19 | 0.25g | 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 |
| 无锡福祈制药有限公司 | 无锡福祈制药有限公司 | 国药准字H20080642 | 2024/05/10 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 浙江尖峰药业有限公司 | 浙江尖峰药业有限公司 | 国药准字H20070267 | 2023/09/12 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 华北制药股份有限公司 | 华北制药股份有限公司 | 国药准字H20080297 | 2022/12/07 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20223441 | 2022/06/28 | 0.25g | 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 |
| 湖南华纳大药厂股份有限公司 | 湖南华纳大药厂股份有限公司 | 国药准字H20080016 | 2022/03/08 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 海南先声药业有限公司 | 海南先声药业有限公司 | 国药准字H20213150 | — | 0.25g | 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 | 杭州中美华东制药有限公司 | 国药准字H20080003 | 2020/12/23 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 邛崃天银制药有限公司 | 邛崃天银制药有限公司 | 国药准字H20080819 | 2020/12/03 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 瀚晖制药有限公司 | 浙江海正药业股份有限公司 | 国药准字H20070081 | 2020/04/28 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| — | 上海罗氏制药有限公司 | 国药准字H20031240 | 2003/12/12 | 0.25g | Other drug (其他药品) | CDE |
| Roche Registration Ltd. | Roche S.p.A. | H20130363 | 1997/07/24 | 0.25g | 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: 13 distinct approval numbers and 13 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 上海罗氏制药有限公司 | 国药准字H20031240 | 0.25g | Category B (乙) | XL04AAM026E001010100723 | NHSA |
| 无锡福祈制药有限公司 | 国药准字H20080642 | 0.25g | Category B (乙) | XL04AAM026E001010101698 | NHSA |
| 邛崃天银制药有限公司 | 国药准字H20080819 | 0.25g | Category B (乙) | XL04AAM026E001010102067 | NHSA |
| 华北制药股份有限公司 | 国药准字H20080297 | 0.25g | Category B (乙) | XL04AAM026E001010102697 | NHSA |
| 山东华鲁制药有限公司 | 国药准字H20100118 | 0.25g | Category B (乙) | XL04AAM026E001010104098 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20080764 | 0.25g | Category B (乙) | XL04AAM026E001010104127 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20223441 | 0.25g | Category B (乙) | XL04AAM026E001010104188 | NHSA |
| 杭州中美华东制药有限公司 | 国药准字H20080003 | 0.25g | Category B (乙) | XL04AAM026E001010104520 | NHSA |
| 浙江长典药物技术开发有限公司 | 国药准字H20070081 | 0.25g | Category B (乙) | XL04AAM026E001010104641 | NHSA |
| 浙江尖峰药业有限公司 | 国药准字H20070267 | 0.25g | Category B (乙) | XL04AAM026E001010104655 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20080016 | 0.25g | Category B (乙) | XL04AAM026E001010104929 | NHSA |
| 海南先声药业有限公司 | 国药准字H20213150 | 0.25g | Category B (乙) | XL04AAM026E001010105849 | NHSA |
| 北大医药股份有限公司 | 国药准字H20133045 | 250mg | Category B (乙) | XL04AAM026E001010109660 | NHSA |
| 上海罗氏制药有限公司 | 国药准字H20031240 | 0.25g | Category B (乙) | XL04AAM026E001010200723 | NHSA |
| 无锡福祈制药有限公司 | 国药准字H20080642 | 0.25g | Category B (乙) | XL04AAM026E001010201698 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20080764 | 0.25g | Category B (乙) | XL04AAM026E001010204127 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20223441 | 0.25g | Category B (乙) | XL04AAM026E001010204188 | NHSA |
| 杭州中美华东制药有限公司 | 国药准字H20080003 | 0.25g | Category B (乙) | XL04AAM026E001010204520 | NHSA |
| 浙江长典药物技术开发有限公司 | 国药准字H20070081 | 0.25g | Category B (乙) | XL04AAM026E001010204641 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20223441 | 0.25g | Category B (乙) | XL04AAM026E001010304188 | NHSA |
| 浙江长典药物技术开发有限公司 | 国药准字H20070081 | 0.25g | Category B (乙) | XL04AAM026E001010304641 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20223441 | 0.25g | Category B (乙) | XL04AAM026E001010404188 | NHSA |
| 浙江长典药物技术开发有限公司 | 国药准字H20070081 | 0.25g | Category B (乙) | XL04AAM026E001010404641 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20223441 | 0.25g | Category B (乙) | XL04AAM026E001010504188 | NHSA |
| 浙江长典药物技术开发有限公司 | 国药准字H20070081 | 0.25g | Category B (乙) | XL04AAM026E001010504641 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20080016 | 0.25g | Category B (乙) | XL04AAM026E001020104929 | NHSA |
| 湖南华纳大药厂股份有限公司 | 国药准字H20080016 | 0.25g | Category B (乙) | XL04AAM026E001020204929 | 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: 4 filings and 4 distinct first applicants.
Generic 2 · Supplement 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 浙江诺得药业有限公司 | CYHS2600006 | Generic | 2026/01/05 | Not stated by source | CDE |
| 上海罗氏制药有限公司 | CYHB2601769 | Supplement | 2026/09/20 | Not stated by source | CDE |
| 宜昌东阳光长江药业股份有限公司 | CYHS2601858 | Generic | 2026/08/03 | Not stated by source | CDE |
| 杭州中美华东制药有限公司 | CYHB2602033 | Supplement | 2026/11/09 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 28 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 吗替麦考酚酯 | Biocon Limited | Y20240001442 | I | Exact ingredient | 2025/05/16 | CDE |
| 吗替麦考酚酯 | Concord Biotech Limited | Y20210000932 | A | Exact ingredient | 2024/11/09 | CDE |
| 吗替麦考酚酯 | Roche Pharma (Schweiz) AG | Y20190000656 | A | Exact ingredient | 2026/06/16 | CDE |
| 吗替麦考酚酯 | Roche Pharma (Schweiz) Ltd. | Y20190009938 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 | Roche Pharma (Schweiz) Ltd. | Y20190009937 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 | 海正药业（杭州）有限公司 | Y20190009807 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 | 国药集团川抗制药有限公司 | Y20190009643 | A | Exact ingredient | 2025/09/27 | CDE |
| 吗替麦考酚酯 | 无锡福祈制药有限公司 | Y20190008682 | A | Exact ingredient | 2026/07/10 | CDE |
| 吗替麦考酚酯 | 福建科瑞药业有限公司 | Y20190008499 | A | Exact ingredient | 2024/09/04 | CDE |
| 吗替麦考酚酯 | 宜昌东阳光长江药业股份有限公司 | Y20190007112 | A | Exact ingredient | 2023/03/24 | CDE |
| 吗替麦考酚酯 | 丽珠集团新北江制药股份有限公司 | Y20190006954 | A | Exact ingredient | 2023/03/24 | CDE |
| 吗替麦考酚酯 | 南京鲸轮制药有限公司 | Y20190006521 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 | 海南卓科制药有限公司 | Y20190006157 | A | Exact ingredient | 2026/02/25 | CDE |
| 吗替麦考酚酯 | 湖北午时药业股份有限公司 | Y20190006087 | A | Exact ingredient | 2025/12/24 | CDE |
| 吗替麦考酚酯 | 济川药业集团有限公司 | Y20190006082 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 | 山东辰龙药业有限公司 | Y20190005848 | A | Exact ingredient | 2024/02/08 | CDE |
| 吗替麦考酚酯 | 重庆莱美隆宇药业有限公司 | Y20190005179 | A | Exact ingredient | 2025/06/05 | CDE |
| 吗替麦考酚酯 | 福州海王福药制药有限公司 | Y20190005113 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 | 河北柏奇药业有限公司 | Y20190004938 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 | 江苏吴中医药集团有限公司苏州制药厂 | Y20190004770 | A | Exact ingredient | 2025/06/28 | CDE |
| 吗替麦考酚酯 | 华北制药华胜有限公司 | Y20190004299 | A | Exact ingredient | 2024/12/31 | CDE |
| 吗替麦考酚酯 | 扬州市三药制药有限公司 | Y20190004067 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 | 湖北天义药业有限公司 | Y20190004056 | A | Exact ingredient | 2026/05/20 | CDE |
| 吗替麦考酚酯 | 湖南华纳大药厂手性药物有限公司 | Y20190004030 | A | Exact ingredient | 2025/12/19 | CDE |
| 吗替麦考酚酯 | 江苏神龙药业股份有限公司 | Y20190003083 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 | 山东新时代药业有限公司 | Y20190002063 | A | Exact ingredient | 2025/01/11 | CDE |
| 吗替麦考酚酯 | 江苏九阳生物制药有限公司 | Y20190001419 | A | Exact ingredient | 2026/10/29 | CDE |
| 吗替麦考酚酯 | 重庆新大新药业股份有限公司 | Y20190001329 | A | Exact ingredient | 2026/05/20 | CDE |
| 吗替麦考酚酯 | 华润三九（唐山）药业有限公司 | Y20190001226 | A | Exact ingredient | 2024/04/11 | CDE |
| 吗替麦考酚酯 | 海正药业（杭州）有限公司 | Y20180000985 | A | Exact ingredient | 2024/12/07 | CDE |
| 吗替麦考酚酯 | Roche Pharma (Schweiz) Ltd. | Y20170002082 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 | 上海罗氏制药有限公司 | Y20170001961 | A | Exact ingredient | 2019/01/14 | CDE |
| 吗替麦考酚酯 | 国药集团川抗制药有限公司 | Y20170001960 | A | Exact ingredient | 2022/11/08 | 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.
-
2026/11/09Accepted
-
2026/09/20Accepted
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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