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Cetrorelix Acetate for Injection

As of 13 November 2026, for Cetrorelix Acetate for Injection, 4 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 18 holders.

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

Last 90 days: Accepted: 2 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

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: 18 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 16 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanizedShanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized国药准字H202659012026/09/08See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shandong Xin Shi Dai Pharma Co., Ltd. romanizedShandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202657462026/08/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanizedSuzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized国药准字H202657662026/08/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Changzhou Si Yao Pharmaceutical Co., Ltd. romanizedChangzhou Si Yao Pharmaceutical Co., Ltd. romanized国药准字H202649452026/06/23See sourceGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Hai Chen Pharma Co., Ltd. romanizedNanjing Hai Chen Pharma Co., Ltd. romanized国药准字H202647962026/06/17See sourceGeneric approved under the new chemical-drug registration classificationCDE
Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanizedFujian Ji Nuo Hou Pu Bio Technology Co., Ltd. romanized国药准字H202638062026/03/31See sourceGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Hai Rong Pharmaceutical Co., Ltd. romanizedJiangsu Li Tai Er Pharma Co., Ltd. romanized国药准字H202632892026/02/02See sourceGeneric approved under the new chemical-drug registration classificationCDE
Yang Zi Jiang Pharma Group Guangzhou Hai Rui Pharma Co., Ltd. romanizedYang Zi Jiang Pharma Group Guangzhou Hai Rui Pharma Co., Ltd. romanized国药准字H202557112025/10/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanizedJiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized国药准字H202548952025/07/22See sourceGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Kang Zhou Pharmaceuticals Technology Co., Ltd. romanizedChangzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanized国药准字H202540562025/04/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Kai Feng Ming Ren Pharma Co., Ltd. romanizedKai Feng Ming Ren Pharma Co., Ltd. romanized国药准字H202447602024/08/27See sourceGeneric approved under the new chemical-drug registration classificationCDE
Qilu Pharmaceutical Co., Ltd.Qilu Pharmaceutical Co., Ltd.国药准字H202434802024/04/11See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hainan Zhong He Pharma Co., Ltd. romanizedHainan Zhong He Pharma Co., Ltd. romanized国药准字H202341442023/09/12See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hui Ling Pharmaceutical (Zhongguo) Co., Ltd. romanizedShenzhen Han Yu Pharma Co., Ltd. romanized国药准字H201834682023/07/10See sourceDrug that passed quality-and-efficacy consistency evaluationCDE
Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanizedHAINAN HUALON PHARMACEUTICAL CO.,LTD国药准字H202336302023/05/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Changchun Jin Sai Pharma Co., Ltd. romanizedChangchun Jin Sai Pharma Co., Ltd. romanized国药准字H202239132022/11/30See sourceGeneric approved under the new chemical-drug registration classificationCDE
Li Zhu Group Li Zhu Pharmaceutical Factory romanizedNanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized国药准字H202139772021/12/31See sourceGeneric approved under the new chemical-drug registration classificationCDE
Merck Europe B.V.Pierre Fabre Medicament Production, Aquitaine Pharm InternationalH201404762005/02/21See sourceImported 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: 16 distinct approval numbers and 16 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Yang Zi Jiang Pharma Group Guangzhou Hai Rui Pharma Co., Ltd. romanized国药准字H20255711See sourceNot stated by sourceXH01CCX013B001010100568NHSA
Changzhou Si Yao Pharmaceutical Co., Ltd. romanized国药准字H20264945See sourceNot stated by sourceXH01CCX013B001010101389NHSA
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H20264796See sourceNot stated by sourceXH01CCX013B001010101563NHSA
Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized国药准字H20265901See sourceNot stated by sourceXH01CCX013B001010102841NHSA
Changchun Jin Sai Pharma Co., Ltd. romanized国药准字H20223913See sourceNot stated by sourceXH01CCX013B001010103315NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H20243480See sourceNot stated by sourceXH01CCX013B001010104021NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H20265746See sourceNot stated by sourceXH01CCX013B001010104188NHSA
Hainan Zhong He Pharma Co., Ltd. romanized国药准字H20234144See sourceNot stated by sourceXH01CCX013B001010105842NHSA
Kai Feng Ming Ren Pharma Co., Ltd. romanized国药准字H20244760See sourceNot stated by sourceXH01CCX013B001010107462NHSA
Merck (Schweiz) AG国药准字HJ20140476See sourceNot stated by sourceXH01CCX013B001010178860NHSA
Hui Ling Pharmaceutical (Zhongguo) Co., Ltd. romanized国药准字H20183468See sourceNot stated by sourceXH01CCX013B001010179260NHSA
Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized国药准字H20254895See sourceNot stated by sourceXH01CCX013B001010180539NHSA
Wuhan Ren Fu Li Kang Pharma Co., Ltd. romanized国药准字H20263806See sourceNot stated by sourceXH01CCX013B001010181917NHSA
Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized国药准字H20233630See sourceNot stated by sourceXH01CCX013B001010183116NHSA
Nanjing Kang Zhou Pharmaceuticals Technology Co., Ltd. romanized国药准字H20254056See sourceNot stated by sourceXH01CCX013B001010183233NHSA
Li Zhu Group Li Zhu Pharmaceutical Factory romanized国药准字H20213977See sourceNot stated by sourceXH01CCX013B001010201570NHSA
Hainan Zhong He Pharma Co., Ltd. romanized国药准字H20234144See sourceNot stated by sourceXH01CCX013B001010205842NHSA
Merck (Schweiz) AG国药准字HJ20140476See sourceNot stated by sourceXH01CCX013B001010278860NHSA
Hui Ling Pharmaceutical (Zhongguo) Co., Ltd. romanized国药准字H20183468See sourceNot stated by sourceXH01CCX013B001010279260NHSA
Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized国药准字H20233630See sourceNot stated by sourceXH01CCX013B001010283116NHSA
Li Zhu Group Li Zhu Pharmaceutical Factory romanized国药准字H20213977See sourceNot stated by sourceXH01CCX013B001010301570NHSA
Hui Ling Pharmaceutical (Zhongguo) Co., Ltd. romanized国药准字H20183468See sourceNot stated by sourceXH01CCX013B001010379260NHSA
Li Zhu Group Li Zhu Pharmaceutical Factory romanized国药准字H20213977See sourceNot stated by sourceXH01CCX013B001010401570NHSA
Li Zhu Group Li Zhu Pharmaceutical Factory romanized国药准字H20213977See sourceNot stated by sourceXH01CCX013B001010501570NHSA
Li Zhu Group Li Zhu Pharmaceutical Factory romanized国药准字H20213977See sourceNot stated by sourceXH01CCX013B001010601570NHSA

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: 4 filings and 4 distinct first applicants.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanizedCYHS2602026Generic2026/08/17Not stated by sourceCDE
Beijing SL Pharmaceutical Co., Ltd.CYHS2504311Generic2025/12/18Not stated by sourceCDE
Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanizedCYHS2500614Generic2025/02/07Not stated by sourceCDE
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS2602620Generic2026/10/26Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanizedCYHS2602026Generic2026/08/17Not stated by sourceCDE
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS2602620Generic2026/10/26Not stated by sourceCDE
API registrations

Non-component matches: 12 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
醋酸西曲瑞克 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20260000749IExact ingredient2026/08/27CDE
醋酸西曲瑞克 · No verified English nameBCN PEPTIDES, SAY20240001059IExact ingredient2025/01/15CDE
醋酸西曲瑞克 · No verified English nameShanxi Tong Da Pharma Co., Ltd. romanizedY20240000543AExact ingredient2026/01/28CDE
醋酸西曲瑞克 · No verified English nameNanjing Hai Rong Pharmaceutical Co., Ltd. romanizedY20230001331AExact ingredient2025/08/22CDE
醋酸西曲瑞克 · No verified English nameSuzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanizedY20230000378AExact ingredient2024/12/07CDE
醋酸西曲瑞克 · No verified English nameKai Feng Ming Ren Pharma Co., Ltd. romanizedY20220000773AExact ingredient2024/08/20CDE
醋酸西曲瑞克 · No verified English nameJiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanizedY20220000567AExact ingredient2024/06/06CDE
醋酸西曲瑞克 · No verified English nameShanghai Su Hao Yi Ming Pharmaceutical Co., Ltd. romanizedY20220000449AExact ingredient2024/10/26CDE
醋酸西曲瑞克 · No verified English nameChengdu Sheng Nuo Biopharmaceutical Co., Ltd. romanizedY20220000342AExact ingredient2024/02/23CDE
醋酸西曲瑞克 · No verified English nameHan Yu Pharma (Wuhan) Co., Ltd. romanizedY20220000234AExact ingredient2026/10/14CDE
醋酸西曲瑞克 · No verified English nameHainan Zhong He Pharma Co., Ltd. romanizedY20210001264AExact ingredient2024/06/06CDE
醋酸西曲瑞克 · No verified English nameHaerbin Ji Xiang Long Bio Technology Co., Ltd. romanizedY20210000112AExact ingredient2024/01/17CDE
醋酸西曲瑞克 · No verified English nameZhong Tai Sheng Hua Co., Ltd. romanizedY20190001147AExact ingredient2026/07/03CDE
醋酸西曲瑞克 · No verified English nameKai Feng Ming Ren Pharma Co., Ltd. romanizedY20170000653IExact ingredient—CDE
醋酸西曲瑞克 · No verified English nameShenzhen Han Yu Pharma Co., Ltd. romanizedY20170000279AExact ingredient2022/09/27CDE

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. 2026/10/26Accepted

    Nanjing Hai Na Pharmaceutical Co., Ltd. romanized

    CYHS2602620

    Fact date: 2026/10/26 · Site observation date: 2026/10/27

    View source ↗
  2. 2026/08/17Accepted

    Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized

    CYHS2602026

    Fact date: 2026/08/17 · 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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