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Ibrutinib Capsules(伊布替尼胶囊)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 5 applicationsNo longer listed under review: 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 holders10View records ↓
Under-review filings9View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers5View records ↓
API companies with A status14View records ↓
Chemical-drug catalogue
Loaded records: 10 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 |
|---|---|---|---|---|---|---|
| 浙江华义制药有限公司 | 浙江华义制药有限公司 | 国药准字H20264337 | 2026/05/19 | 140mg | 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 |
| 上海现代制药股份有限公司 | 国药一心制药有限公司 | 国药准字H20264339 | 2026/05/19 | 140mg | 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 |
| 重庆药友制药有限责任公司 | 重庆药友制药有限责任公司 | 国药准字H20263693 | 2026/03/25 | 140mg | 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 |
| 南京正大天晴制药有限公司 | 南京正大天晴制药有限公司 | 国药准字H20254986 | 2025/07/29 | 140mg | 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 |
| 华东医药（西安）博华制药有限公司 | 杭州中美华东制药有限公司 | 国药准字H20254682 | 2025/06/30 | 140mg | 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 |
| 江西科睿药业有限公司 | 江西科睿药业有限公司 | 国药准字H20253113 | 2025/01/08 | 140mg | 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 |
| 山东齐都药业有限公司 | 北京亚宝生物药业有限公司 | 国药准字H20249566 | 2024/12/01 | 140mg | 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 |
| M/s Natco Pharma Limited | M/s Natco Pharma Limited | 国药准字HJ20240120 | 2024/10/29 | 140mg | 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 |
| 先声药业有限公司 | 先声药业有限公司 | 国药准字H20223719 | 2022/10/11 | 140mg | 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 |
| Pharmacyclics LLC | Catalent CTS LLC | H20170350 | 2017/08/24 | 140mg | 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: 5 distinct approval numbers and 5 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京双鹭药业股份有限公司 | 国药准字H20266103 | 140mg | Category B (乙) | XL01ELY299E001010100148 | NHSA |
| 重庆药友制药有限责任公司 | 国药准字H20263693 | 140mg | Category B (乙) | XL01ELY299E001010101066 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20254986 | 140mg | Category B (乙) | XL01ELY299E001010101606 | NHSA |
| Janssen-Cilag International NV | 国药准字HJ20181066 | 140mg | Category B (乙) | XL01ELY299E001010182102 | NHSA |
| Janssen-Cilag International NV | 国药准字HJ20181066 | 140mg | Category B (乙) | XL01ELY299E001010282102 | NHSA |
| 浙江华义制药有限公司 | 国药准字H20264337 | 140mg | Category B (乙) | XL01ELY299E001010104650 | 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: 9 filings and 8 distinct first applicants.
Generic 4 · Supplement 4 · Import re-registration 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 宁波美诺华天康药业有限公司;江苏华阳制药有限公司 | CYHS2503756 | Generic | 2025/10/22 | Not stated by source | CDE |
| Janssen-Cilag International NV;Catalent CTS LLC;Cilag AG | JYHB2600561 | Supplement | 2026/10/21 | Not stated by source | CDE |
| 金鸿药业股份有限公司 | CYHS2602368 | Generic | 2026/09/21 | Not stated by source | CDE |
| 上海现代制药股份有限公司;国药一心制药有限公司 | CYHB2601777 | Supplement | 2026/09/21 | Not stated by source | CDE |
| 山东齐都药业有限公司;北京亚宝生物药业有限公司 | CYHB2601763 | Supplement | 2026/09/20 | Not stated by source | CDE |
| Janssen-Cilag International NV;Catalent CTS LLC;Cilag AG;Xian-Janssen Pharmaceutical Ltd. | JYHZ2600188 | Import re-registration | 2026/08/05 | Not stated by source | CDE |
| 蚌埠丰原涂山制药有限公司;北京亚宝生物药业有限公司 | CYHS2601071 | Generic | 2026/05/12 | Not stated by source | CDE |
| 上海创诺制药有限公司 | CYHS2503353 | Generic | 2025/09/10 | Not stated by source | CDE |
| 华东医药（西安）博华制药有限公司;杭州中美华东制药有限公司 | CYHB2602007 | Supplement | 2026/11/05 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 14 companies with A status and 10 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 |
|---|---|---|---|---|---|---|
| 伊布替尼 | 浙江奥翔药业股份有限公司 | Y20260000087 | I | Exact ingredient | 2026/02/10 | CDE |
| 伊布替尼 | 浙江奥翔药业股份有限公司 | Y20250001309 | I | Exact ingredient | 2025/12/16 | CDE |
| 伊布替尼 | 连云港贵科药业有限公司 | Y20250000804 | I | Exact ingredient | 2025/08/20 | CDE |
| 伊布替尼 | Cdymax(India）Pharma Private Limited | Y20250000365 | I | Exact ingredient | 2025/06/05 | CDE |
| 伊布替尼 | 重庆瑞泊莱制药有限公司 | Y20250000516 | I | Exact ingredient | 2025/05/30 | CDE |
| 伊布替尼 | 四川弘远药业有限公司 | Y20250000479 | I | Exact ingredient | 2025/05/28 | CDE |
| 伊布替尼 | 山东鲁抗医药股份有限公司 | Y20250000133 | I | Exact ingredient | 2025/02/08 | CDE |
| 伊布替尼 | 重庆胜凯制药有限公司 | Y20240001561 | A | Exact ingredient | 2026/06/04 | CDE |
| 伊布替尼 | 浙江京圣药业有限公司 | Y20240001142 | A | Exact ingredient | 2026/10/29 | CDE |
| 伊布替尼 | 广州科锐特药业有限公司 | Y20240000976 | I | Exact ingredient | 2024/11/27 | CDE |
| 伊布替尼 | 江苏威奇达药业有限公司 | Y20240001272 | I | Exact ingredient | 2024/11/14 | CDE |
| 伊布替尼 | 宣城美诺华药业有限公司 | Y20240001011 | A | Exact ingredient | 2026/06/11 | CDE |
| 伊布替尼 | 山东新时代药业有限公司 | Y20240000915 | A | Exact ingredient | 2026/04/14 | CDE |
| 伊布替尼 | 浙江华义制药有限公司 | Y20240000629 | A | Exact ingredient | 2026/09/21 | CDE |
| 伊布替尼 | 四川科伦药业股份有限公司 | Y20240000254 | A | Exact ingredient | 2025/11/10 | CDE |
| 伊布替尼 | 金鸿药业股份有限公司 | Y20240000272 | A | Exact ingredient | 2026/01/08 | CDE |
| 伊布替尼 | 重庆凯林制药有限公司 | Y20230000989 | A | Exact ingredient | 2026/08/21 | CDE |
| 伊布替尼 | 广东莱佛士制药技术有限公司 | Y20230001268 | A | Exact ingredient | 2026/09/09 | CDE |
| 伊布替尼 | Dr. Reddy’s Laboratories Ltd. | Y20230001057 | I | Exact ingredient | 2024/01/03 | CDE |
| 伊布替尼 | 江苏慧聚药业股份有限公司 | Y20230000804 | A | Exact ingredient | 2025/01/26 | CDE |
| 伊布替尼 | 江西科睿药业有限公司 | Y20230000444 | A | Exact ingredient | 2025/04/26 | CDE |
| 伊布替尼 | 山东安信制药有限公司 | Y20230000290 | A | Exact ingredient | 2025/01/12 | CDE |
| 伊布替尼 | 重庆博腾制药科技股份有限公司 | Y20210001234 | A | Exact ingredient | 2026/03/14 | CDE |
| 伊布替尼 | 先声药业有限公司 | Y20200001176 | A | Exact ingredient | 2024/01/17 | 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.
-
2026/11/05Accepted
华东医药（西安）博华制药有限公司;杭州中美华东制药有限公司
CYHB2602007
Fact date: 2026/11/05 · Site observation date: 2026/11/06
View source ↗ -
2026/11/04No longer listed under review
浙江诺得药业有限公司
CYHS2500657
Fact date: 2026/11/04 · Site observation date: 2026/11/04
Accepted: 2025/02/09
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/11/03Marketing application approved
成都康弘药业集团股份有限公司
CYHS2502292 · 国药准字H20266472
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 86 ↗ -
2026/10/21Accepted
Janssen-Cilag International NV;Catalent CTS LLC;Cilag AG
JYHB2600561
Fact date: 2026/10/21 · Site observation date: 2026/10/22
View source ↗ -
2026/09/21Accepted
-
2026/09/21Accepted
上海现代制药股份有限公司;国药一心制药有限公司
CYHB2601777
Fact date: 2026/09/21 · Site observation date: 2026/10/22
View source ↗ -
2026/09/20Accepted
山东齐都药业有限公司;北京亚宝生物药业有限公司
CYHB2601763
Fact date: 2026/09/20 · Site observation date: 2026/10/22
View source ↗
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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