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Sign in to subscribeAs of 13 November 2026, for Ixazomib Citrate Capsules, 7 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 2 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as NINLARO (NDA 208462, TAKEDA PHARMACEUTICALS USA INC).
Last 90 days: Accepted: 3 applicationsSupplement delivery: 3 applications
Current coverage may be incomplete
The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.
Orange Book source export date: 2026/11/06. Version: 2026-11-06.
Showing 1 of 1 distinct brand names.
A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.
Verified official English dosage form: Capsules. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| NINLARO | TAKEDA PHARMACEUTICALS USA INC | NDA 208462 · Product no. 001, 002, 003 | CAPSULE | ORAL | HUMAN PRESCRIPTION DRUG | 2015/11/20 |
No listings in this group among the displayed brand names.
Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.
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.
Loaded records: 2 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 1 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 |
|---|---|---|---|---|---|---|
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20253310 | 2025/01/24 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20253308 | 2025/01/24 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20253309 | 2025/01/24 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Takeda Pharma A/S | Haupt Pharma Amareg GmbH | H20180012 | 2018/04/12 | 2.3mg | Imported originator drug | CDE |
| Takeda Pharma A/S | Haupt Pharma Amareg GmbH | H20180011 | 2018/04/12 | 3mg | Imported originator drug | CDE |
| Takeda Pharma A/S | Haupt Pharma Amareg GmbH | H20180010 | 2018/04/12 | 4mg | 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.
Loaded records: 3 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Takeda Pharma A/S | 国药准字HJ20180012 | See source | Category B | XL01XGY306E001010179422 | NHSA |
| Takeda Pharma A/S | 国药准字HJ20180011 | See source | Category B | XL01XGY306E001020179422 | NHSA |
| Takeda Pharma A/S | 国药准字HJ20180010 | See source | Category B | XL01XGY306E001030179422 | 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.
Loaded records: 7 filings and 3 distinct first applicants.
Generic 7
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized | CYHS2602459 | Generic | 2026/10/09 | Not stated by source | CDE |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized | CYHS2602458 | Generic | 2026/10/09 | Not stated by source | CDE |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized | CYHS2602457 | Generic | 2026/10/09 | Not stated by source | CDE |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | CYHS2601883 | Generic | 2026/08/03 | Not stated by source | CDE |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | CYHS2601882 | Generic | 2026/08/03 | Not stated by source | CDE |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | CYHS2601881 | Generic | 2026/08/03 | Not stated by source | CDE |
| Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd.; Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | CYHS2504526 | Generic | 2026/01/04 | Not stated by source | CDE |
Loaded records: 7 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized | CYHS2602459 | Generic | 2026/10/09 | Not stated by source | CDE |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized | CYHS2602458 | Generic | 2026/10/09 | Not stated by source | CDE |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized | CYHS2602457 | Generic | 2026/10/09 | Not stated by source | CDE |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | CYHS2601883 | Generic | 2026/08/03 | Not stated by source | CDE |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | CYHS2601882 | Generic | 2026/08/03 | Not stated by source | CDE |
| CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | CYHS2601881 | Generic | 2026/08/03 | Not stated by source | CDE |
| Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd.; Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | CYHS2504526 | Generic | 2026/01/04 | Not stated by source | CDE |
Non-component matches: 6 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 |
|---|---|---|---|---|---|---|
| 枸橼酸伊沙佐米 · No verified English name | Shenzhen Wan Le Pharma Co., Ltd. romanized | Y20250001384 | I | Exact ingredient | 2025/12/31 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Chongqing Kai Lin Pharmaceutical Co., Ltd. romanized | Y20250000999 | I | Exact ingredient | 2025/12/19 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized | Y20250001105 | I | Exact ingredient | 2025/10/23 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | Y20250000693 | I | Exact ingredient | 2025/08/11 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20250000549 | A | Exact ingredient | 2026/11/05 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Su Zhou Yi Fan Pharma Co., Ltd. romanized | Y20250000670 | I | Exact ingredient | 2025/07/08 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | Y20250000534 | A | Exact ingredient | 2026/10/21 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized | Y20250000103 | A | Exact ingredient | 2026/06/30 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20240001475 | A | Exact ingredient | 2026/07/21 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Chongqing Mai De Kai Pharmaceuticals Co., Ltd. romanized | Y20240000575 | I | Exact ingredient | 2025/08/29 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Qilu Pharmaceutical Co., Ltd. | Y20230000721 | A | Exact ingredient | 2026/05/22 | CDE |
| 枸橼酸伊沙佐米 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20230000110 | A | Exact ingredient | 2024/11/21 | 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.
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.
JYHB2600410
Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 22 ↗JYHB2600409
Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 21 ↗JYHB2600408
Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 20 ↗CYHS2602459
Fact date: 2026/10/09 · Site observation date: 2026/10/22
View source ↗CYHS2602458
Fact date: 2026/10/09 · Site observation date: 2026/10/22
View source ↗CYHS2602457
Fact date: 2026/10/09 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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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