YaoGeJu

Public drug landscapesDrug landscape

Ixazomib Citrate Capsules

As 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

Follow for free
Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

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.

Same dosage form

Brand nameApplicant (source text)Application numberDosage 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

Other dosage forms of the same ingredient

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.

Ingredient cross-list details ↗

Which companies are listed, and at what stages?

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.

Chemical-drug catalogue

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Qilu Pharmaceutical Co., Ltd.Qilu Pharmaceutical Co., Ltd.国药准字H202533102025/01/24See sourceGeneric approved under the new chemical-drug registration classificationCDE
Qilu Pharmaceutical Co., Ltd.Qilu Pharmaceutical Co., Ltd.国药准字H202533082025/01/24See sourceGeneric approved under the new chemical-drug registration classificationCDE
Qilu Pharmaceutical Co., Ltd.Qilu Pharmaceutical Co., Ltd.国药准字H202533092025/01/24See sourceGeneric approved under the new chemical-drug registration classificationCDE
Takeda Pharma A/SHaupt Pharma Amareg GmbHH201800122018/04/122.3mgImported originator drugCDE
Takeda Pharma A/SHaupt Pharma Amareg GmbHH201800112018/04/123mgImported originator drugCDE
Takeda Pharma A/SHaupt Pharma Amareg GmbHH201800102018/04/124mgImported originator drugCDE

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: 3 distinct approval numbers and 1 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Takeda Pharma A/S国药准字HJ20180012See sourceCategory BXL01XGY306E001010179422NHSA
Takeda Pharma A/S国药准字HJ20180011See sourceCategory BXL01XGY306E001020179422NHSA
Takeda Pharma A/S国药准字HJ20180010See sourceCategory BXL01XGY306E001030179422NHSA

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: 7 filings and 3 distinct first applicants.

Generic 7

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanizedCYHS2602459Generic2026/10/09Not stated by sourceCDE
Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanizedCYHS2602458Generic2026/10/09Not stated by sourceCDE
Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanizedCYHS2602457Generic2026/10/09Not stated by sourceCDE
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTDCYHS2601883Generic2026/08/03Not stated by sourceCDE
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTDCYHS2601882Generic2026/08/03Not stated by sourceCDE
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTDCYHS2601881Generic2026/08/03Not stated by sourceCDE
Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd.; Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanizedCYHS2504526Generic2026/01/04Not stated by sourceCDE
New generic filings in 2026

Loaded records: 7 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanizedCYHS2602459Generic2026/10/09Not stated by sourceCDE
Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanizedCYHS2602458Generic2026/10/09Not stated by sourceCDE
Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanizedCYHS2602457Generic2026/10/09Not stated by sourceCDE
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTDCYHS2601883Generic2026/08/03Not stated by sourceCDE
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTDCYHS2601882Generic2026/08/03Not stated by sourceCDE
CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTDCYHS2601881Generic2026/08/03Not stated by sourceCDE
Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd.; Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanizedCYHS2504526Generic2026/01/04Not stated by sourceCDE
API registrations

Non-component matches: 6 companies with A status and 6 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
枸橼酸伊沙佐米 · No verified English nameShenzhen Wan Le Pharma Co., Ltd. romanizedY20250001384IExact ingredient2025/12/31CDE
枸橼酸伊沙佐米 · No verified English nameChongqing Kai Lin Pharmaceutical Co., Ltd. romanizedY20250000999IExact ingredient2025/12/19CDE
枸橼酸伊沙佐米 · No verified English nameLian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanizedY20250001105IExact ingredient2025/10/23CDE
枸橼酸伊沙佐米 · No verified English nameHuadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd.Y20250000693IExact ingredient2025/08/11CDE
枸橼酸伊沙佐米 · No verified English nameSichuan Qing Mu Pharmaceutical Co., Ltd. romanizedY20250000549AExact ingredient2026/11/05CDE
枸橼酸伊沙佐米 · No verified English nameSu Zhou Yi Fan Pharma Co., Ltd. romanizedY20250000670IExact ingredient2025/07/08CDE
枸橼酸伊沙佐米 · No verified English nameSichuan Hui Yu Pharmaceutical Co., Ltd. romanizedY20250000534AExact ingredient2026/10/21CDE
枸橼酸伊沙佐米 · No verified English nameJiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedY20250000103AExact ingredient2026/06/30CDE
枸橼酸伊沙佐米 · No verified English nameShandong Xin Shi Dai Pharma Co., Ltd. romanizedY20240001475AExact ingredient2026/07/21CDE
枸橼酸伊沙佐米 · No verified English nameChongqing Mai De Kai Pharmaceuticals Co., Ltd. romanizedY20240000575IExact ingredient2025/08/29CDE
枸橼酸伊沙佐米 · No verified English nameQilu Pharmaceutical Co., Ltd.Y20230000721AExact ingredient2026/05/22CDE
枸橼酸伊沙佐米 · No verified English nameSichuan Kelun Pharmaceutical Co., Ltd.Y20230000110AExact ingredient2024/11/21CDE

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: 2026/11/13 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.

  1. 2026/10/20Supplement delivery

    Wu Tian (Zhongguo) International Trading Co., Ltd. romanized

    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 ↗
  2. 2026/10/20Supplement delivery

    Wu Tian (Zhongguo) International Trading Co., Ltd. romanized

    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 ↗
  3. 2026/10/20Supplement delivery

    Wu Tian (Zhongguo) International Trading Co., Ltd. romanized

    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 ↗
  4. 2026/10/09Accepted

    Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized

    CYHS2602459

    Fact date: 2026/10/09 · Site observation date: 2026/10/22

    View source ↗
  5. 2026/10/09Accepted

    Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized

    CYHS2602458

    Fact date: 2026/10/09 · Site observation date: 2026/10/22

    View source ↗
  6. 2026/10/09Accepted

    Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized; Dong Yao Pharma Co., Ltd. romanized

    CYHS2602457

    Fact date: 2026/10/09 · Site observation date: 2026/10/22

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/13 06:42
Chemical-drug catalogue
Last successful update: 2026/11/13 06:39

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: 2026/11/13 06:41
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: 2026/11/12 18:32 · Current coverage may be incomplete

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.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/13 08:09 · 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: 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.

Free follow

Follow changes to Ixazomib Citrate Capsules

Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.

Confirmation links expire in 7 days. No digest is sent before confirmation; existing follows are not duplicated.

Sign in to choose products