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Ziprasidone Hydrochloride Capsules

As of 13 November 2026, for Ziprasidone Hydrochloride Capsules, 9 applications are listed as under review at China's CDE; 4 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 GEODON (NDA 020825, VIATRIS SPECIALTY LLC).

Last 90 days: Accepted: 4 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 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
GEODON VIATRIS SPECIALTY LLC NDA 020825 · Product no. 001, 002, 003, 004 CAPSULE ORAL HUMAN PRESCRIPTION DRUG 2001/02/05

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
GEODON PFIZER INC NDA 021483 · Product no. 001 SUSPENSION ORAL DISCONTINUED 2006/03/29

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
Hunan Jiudian Pharmaceutical Co., LtdHunan Jiudian Pharmaceutical Co., Ltd国药准字H202534102025/02/20See sourceGeneric approved under the new chemical-drug registration classificationCDE
Pfizer Australia Pty LimitedPfizer Australia Pty LimitedH201604102007/01/1020mgImported originator drugCDE
Pfizer Australia Pty LimitedPfizer Australia Pty LimitedH201604132007/01/1080mgImported originator drugCDE
Pfizer Australia Pty LimitedPfizer Australia Pty LimitedH201604122007/01/1060mgImported originator drugCDE
Pfizer Australia Pty LimitedPfizer Australia Pty LimitedH201604112007/01/1040mgImported 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: 4 distinct approval numbers and 3 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Jiangsu En Hua Pharma Co., Ltd. romanized国药准字H20061142See sourceCategory BXN05AEQ010E001010101436NHSA
Hunan Jiudian Pharmaceutical Co., Ltd国药准字H20253410See sourceCategory BXN05AEQ010E001010104942NHSA
Viatris Pharma GmbH国药准字HJ20160410See sourceCategory BXN05AEQ010E001010178716NHSA
Viatris Pharma GmbH国药准字HJ20160410See sourceCategory BXN05AEQ010E001010278716NHSA
Viatris Pharma GmbH国药准字HJ20160411See sourceCategory BXN05AEQ010E001020178716NHSA

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 5 distinct first applicants.

Supplement 1 · Generic 8

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu En Hua Pharma Co., Ltd. romanizedCYHB2650157Supplement2026/07/13Not stated by sourceCDE
Hefei Ying Tai Pharmaceutical Co., Ltd. romanizedCYHS2602257Generic2026/09/10Not stated by sourceCDE
Hefei Ying Tai Pharmaceutical Co., Ltd. romanizedCYHS2602256Generic2026/09/10Not stated by sourceCDE
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedCYHS2601814Generic2026/07/28Not stated by sourceCDE
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedCYHS2601813Generic2026/07/28Not stated by sourceCDE
Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanizedCYHS2600263Generic2026/01/23Not stated by sourceCDE
Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanizedCYHS2600262Generic2026/01/23Not stated by sourceCDE
Anhui Pioneer Pharmaceutical Co., LtdCYHS2602730Generic2026/11/06Not stated by sourceCDE
Anhui Pioneer Pharmaceutical Co., LtdCYHS2602729Generic2026/11/06Not stated by sourceCDE
New generic filings in 2026

Loaded records: 8 filings and 4 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hefei Ying Tai Pharmaceutical Co., Ltd. romanizedCYHS2602257Generic2026/09/10Not stated by sourceCDE
Hefei Ying Tai Pharmaceutical Co., Ltd. romanizedCYHS2602256Generic2026/09/10Not stated by sourceCDE
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedCYHS2601814Generic2026/07/28Not stated by sourceCDE
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedCYHS2601813Generic2026/07/28Not stated by sourceCDE
Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanizedCYHS2600263Generic2026/01/23Not stated by sourceCDE
Chongqing Rui En Pharmaceuticals Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanizedCYHS2600262Generic2026/01/23Not stated by sourceCDE
Anhui Pioneer Pharmaceutical Co., LtdCYHS2602730Generic2026/11/06Not stated by sourceCDE
Anhui Pioneer Pharmaceutical Co., LtdCYHS2602729Generic2026/11/06Not stated by sourceCDE
API registrations

Non-component matches: 7 companies with A status and 5 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸齐拉西酮 · No verified English nameZhi En Bio Technology Co., Ltd. romanizedY20250000981IExact ingredient2025/09/11CDE
盐酸齐拉西酮 · No verified English nameHebei Guo Long Pharmaceutical Co., Ltd. romanizedY20250000817IExact ingredient2025/08/13CDE
甲磺酸齐拉西酮 · No verified English nameZhejiang Guo Bang Pharma Co., Ltd. romanizedY20250000366ISalt-normalized ingredient2025/04/22CDE
盐酸齐拉西酮 · No verified English nameZhejiang Guo Bang Pharma Co., Ltd. romanizedY20250000359AExact ingredient2026/11/04CDE
甲磺酸齐拉西酮 · No verified English nameHebei Guo Long Pharmaceutical Co., Ltd. romanizedY20250000265ASalt-normalized ingredient2026/11/08CDE
盐酸齐拉西酮 · No verified English nameHebei Guo Long Pharmaceutical Co., Ltd. romanizedY20250000149AExact ingredient2026/10/11CDE
甲磺酸齐拉西酮三水合物 · No verified English nameChongqing Sheng Hua Xi Pharma Co., Ltd. romanizedY20250000032ISalt-normalized ingredient2025/01/24CDE
盐酸齐拉西酮 · No verified English nameChongqing Sheng Hua Xi Pharma Co., Ltd. romanizedY20230001116AExact ingredient2025/04/09CDE
甲磺酸齐拉西酮 · No verified English nameJiangsu Yu Tian Pharmaceuticals Co., Ltd. romanizedY20230000676ASalt-normalized ingredient2026/10/16CDE
盐酸齐拉西酮 · No verified English nameHunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanizedY20230000364AExact ingredient2026/08/14CDE
盐酸齐拉西酮 · No verified English nameJiangsu En Hua Pharma Co., Ltd. romanizedY20190009730AExact ingredient—CDE
甲磺酸齐拉西酮 · No verified English nameJiangsu En Hua Pharma Co., Ltd. romanizedY20190007393ASalt-normalized ingredient2024/10/09CDE
甲磺酸齐拉西酮 · No verified English nameChongqing Sheng Hua Xi Pharma Co., Ltd. romanizedY20190005550ASalt-normalized ingredient2025/11/29CDE
盐酸齐拉西酮 · No verified English nameChongqing Sheng Hua Xi Pharma Co., Ltd. romanizedY20190004748AExact ingredient2026/01/09CDE
盐酸齐拉西酮 · No verified English nameJiangsu En Hua Pharma Co., Ltd. romanizedY20170002014AExact ingredient2026/01/23CDE
盐酸齐拉西酮 · No verified English nameXiamen En Cheng Pharmaceutical Co., Ltd. romanizedY20170001346AExact ingredient2024/04/02CDE
盐酸齐拉西酮 · No verified English nameQi Lu Tian He Hui Shi Pharmaceutical Co., Ltd. romanizedY20170000197IExact ingredient—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: 2026/11/13 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. 2026/11/06Accepted

    Anhui Pioneer Pharmaceutical Co., Ltd

    CYHS2602730

    Fact date: 2026/11/06 · Site observation date: 2026/11/07

    View source ↗
  2. 2026/11/06Accepted

    Anhui Pioneer Pharmaceutical Co., Ltd

    CYHS2602729

    Fact date: 2026/11/06 · Site observation date: 2026/11/07

    View source ↗
  3. 2026/09/10Accepted

    Hefei Ying Tai Pharmaceutical Co., Ltd. romanized

    CYHS2602257

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

    View source ↗
  4. 2026/09/10Accepted

    Hefei Ying Tai Pharmaceutical Co., Ltd. romanized

    CYHS2602256

    Fact date: 2026/09/10 · 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.

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