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Deferasirox Tablets

As of 13 November 2026, for Deferasirox Tablets, 3 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 3 holders.

Companies, stages and changes, with each record available on this page.

Listed in the US FDA Orange Book as JADENU (NDA 206910, NOVARTIS PHARMACEUTICALS CORP).

Last 90 days: Accepted: 2 applications

Current coverage may be incomplete

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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 3 of 3 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: Tablets. 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
JADENU NOVARTIS PHARMACEUTICALS CORP NDA 206910 · Product no. 001, 002, 003 TABLET ORAL HUMAN PRESCRIPTION DRUG 2015/03/30

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
EXJADE NOVARTIS PHARMACEUTICALS CORP NDA 021882 · Product no. 001, 002, 003 TABLET, FOR SUSPENSION ORAL HUMAN PRESCRIPTION DRUG 2005/11/02
JADENU SPRINKLE NOVARTIS PHARMACEUTICALS CORP NDA 207968 · Product no. 001, 002, 003 GRANULE ORAL HUMAN PRESCRIPTION DRUG 2017/05/18

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: 3 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 3 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Annora Pharma Private LimitedAnnora Pharma Private Limited国药准字HJ202501232025/10/14180mgGeneric approved under the new chemical-drug registration classificationCDE
Annora Pharma Private LimitedAnnora Pharma Private Limited国药准字HJ202501242025/10/14360mgGeneric approved under the new chemical-drug registration classificationCDE
Annora Pharma Private LimitedAnnora Pharma Private Limited国药准字HJ202501222025/10/1490mgGeneric approved under the new chemical-drug registration classificationCDE
MSN Laboratories Private LimitedMSN Laboratories Private Limited国药准字HJ202400012024/01/09360mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Hao Sen Pharma Group Co., Ltd. romanizedJiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H202233012022/05/1090mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Hao Sen Pharma Group Co., Ltd. romanizedJiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H202233022022/05/10360mgGeneric approved under the new chemical-drug registration classificationCDE

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: 8 distinct approval numbers and 4 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H2022330190mgCategory BXV03ACD216A001010101444NHSA
Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized国药准字H2025569990mgCategory BXV03ACD216A001010183029NHSA
MSN Laboratories Private Limited国药准字HJ20240001360mgCategory BXV03ACD216A001010183949NHSA
Annora Pharma Private Limited国药准字HJ2025012290mgCategory BXV03ACD216A001010185434NHSA
Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized国药准字H2025569990mgCategory BXV03ACD216A001010283029NHSA
Jiangsu Hao Sen Pharma Group Co., Ltd. romanized国药准字H20223302360mgCategory BXV03ACD216A001020101444NHSA
Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized国药准字H20255700360mgCategory BXV03ACD216A001020183029NHSA
Annora Pharma Private Limited国药准字HJ20250124360mgCategory BXV03ACD216A001020185434NHSA
Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized国药准字H20255700360mgCategory BXV03ACD216A001020283029NHSA
Annora Pharma Private Limited国药准字HJ20250123180mgCategory BXV03ACD216A001030185434NHSA

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: 3 filings and 2 distinct first applicants.

Generic 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanizedCYHS2600454Generic2026/02/12Not stated by sourceCDE
Hunan Ou Ya Pharma Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanizedCYHS2600193Generic2026/01/16Not stated by sourceCDE
Hunan Ou Ya Pharma Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanizedCYHS2600192Generic2026/01/16Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanizedCYHS2600454Generic2026/02/12Not stated by sourceCDE
Hunan Ou Ya Pharma Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanizedCYHS2600193Generic2026/01/16Not stated by sourceCDE
Hunan Ou Ya Pharma Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanizedCYHS2600192Generic2026/01/16Not stated by sourceCDE
API registrations

Non-component matches: 8 companies with A status and 3 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
地拉罗司 · No verified English nameHunan Ou Ya Pharma Co., Ltd. romanizedY20250001398IExact ingredient2025/12/18CDE
地拉罗司 · No verified English nameXu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanizedY20240001468AExact ingredient2026/07/13CDE
地拉罗司 · No verified English nameSYMED LABS LIMITEDY20240000203AExact ingredient2025/09/28CDE
地拉罗司 · No verified English nameBiocon LimitedY20230001177IExact ingredient2024/03/04CDE
地拉罗司 · No verified English nameHebei Guo Long Pharmaceutical Co., Ltd. romanizedY20220001252AExact ingredient2025/11/22CDE
地拉罗司 · No verified English nameSYMED LABS LIMITEDY20210001023IExact ingredient2024/01/31CDE
地拉罗司 · No verified English nameAlembic Pharmaceuticals LimitedY20200000936AExact ingredient2025/04/11CDE
地拉罗司 · No verified English nameJiangsu Hao Sen Pharma Group Co., Ltd. romanizedY20200001185AExact ingredient2026/09/29CDE
地拉罗司 · No verified English nameHubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanizedY20200000681AExact ingredient2024/08/13CDE
地拉罗司 · No verified English nameMSN Laboratories Private LimitedY20200000199AExact ingredient2025/12/06CDE
地拉罗司 · No verified English nameNanjing Hai Run Pharmaceuticals Co., Ltd. romanizedY20200000037AExact ingredient2026/03/18CDE

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. 2026/08/31Accepted
  2. 2026/08/31Accepted

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.

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