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Oxaliplatin Injection(奥沙利铂注射液)

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
2026/11/10 07:27
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.

Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.

Chemical-drug catalogue

Loaded records: 6 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 6 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
—吉斯美(武汉)制药有限公司 国药准字H20244951 2024/09/19 10ml:50mg Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
健进制药有限公司健进制药有限公司 国药准字H20244822 2024/09/03 10ml:50mg Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
健进制药有限公司健进制药有限公司 国药准字H20244821 2024/09/03 20ml:100mg Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
上海创诺制药有限公司上海创诺制药有限公司 国药准字H20244539 2024/07/30 10ml:50mg Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
山东新时代药业有限公司山东新时代药业有限公司 国药准字H20213540 — 10ml:50mg Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
山东新时代药业有限公司山东新时代药业有限公司 国药准字H20213541 — 20ml:100mg Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
四川汇宇制药股份有限公司四川汇宇制药股份有限公司 国药准字H20213061 2021/01/30 20ml:100mg Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
四川汇宇制药股份有限公司四川汇宇制药股份有限公司 国药准字H20213060 2021/01/30 10ml:50mg Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
—齐鲁制药(海南)有限公司 国药准字H20203217 2020/05/26 20ml:0.1g Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
—齐鲁制药(海南)有限公司 国药准字H20203216 2020/05/26 10ml:50mg Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) CDE
—齐鲁制药(海南)有限公司 国药准字H20203218 2020/05/26 40ml:0.2g Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) 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.

NHSA drug codes

Loaded records: 21 distinct approval numbers and 11 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
深圳海王药业有限公司 国药准字H20031048 20ml:40mg Category B (乙) XL01XAA215B002010100503NHSA
上海创诺制药有限公司 国药准字H20244539 10ml:50mg Category B (乙) XL01XAA215B002010100647NHSA
江苏恒瑞医药股份有限公司 国药准字H20213312 10ml:50mg Category B (乙) XL01XAA215B002010101445NHSA
吉斯美(武汉)制药有限公司 国药准字H20244951 10ml:50mg Category B (乙) XL01XAA215B002010101892NHSA
四川汇宇制药股份有限公司 国药准字H20213060 10ml:50mg Category B (乙) XL01XAA215B002010102317NHSA
山东新时代药业有限公司 国药准字H20213540 10ml:50mg Category B (乙) XL01XAA215B002010104188NHSA
齐鲁制药(海南)有限公司 国药准字H20203216 10ml:50mg Category B (乙) XL01XAA215B002010105847NHSA
湖北一半天制药有限公司 国药准字H20265985 10ml:50mg Category B (乙) XL01XAA215B002010106932NHSA
华夏生生药业(北京)有限公司 国药准字H20255932 20ml:100mg Category B (乙) XL01XAA215B002010109910NHSA
健进制药有限公司 国药准字H20244821 20ml:100mg Category B (乙) XL01XAA215B002010181926NHSA
贵州阜康仁制药有限公司 国药准字H20249605 10ml:50mg Category B (乙) XL01XAA215B002010183571NHSA
深圳海王药业有限公司 国药准字H20031048 20ml:40mg Category B (乙) XL01XAA215B002010200503NHSA
四川汇宇制药股份有限公司 国药准字H20213060 10ml:50mg Category B (乙) XL01XAA215B002010202317NHSA
山东新时代药业有限公司 国药准字H20213540 10ml:50mg Category B (乙) XL01XAA215B002010204188NHSA
齐鲁制药(海南)有限公司 国药准字H20203216 10ml:50mg Category B (乙) XL01XAA215B002010205847NHSA
华夏生生药业(北京)有限公司 国药准字H20255932 20ml:100mg Category B (乙) XL01XAA215B002010209910NHSA
江苏恒瑞医药股份有限公司 国药准字H20213313 20ml:100mg Category B (乙) XL01XAA215B002020101445NHSA
四川汇宇制药股份有限公司 国药准字H20213061 20ml:100mg Category B (乙) XL01XAA215B002020102317NHSA
山东新时代药业有限公司 国药准字H20213541 20ml:100mg Category B (乙) XL01XAA215B002020104188NHSA
齐鲁制药(海南)有限公司 国药准字H20203217 20ml:0.1g Category B (乙) XL01XAA215B002020105847NHSA
湖北一半天制药有限公司 国药准字H20265986 20ml:100mg Category B (乙) XL01XAA215B002020106932NHSA
华夏生生药业(北京)有限公司 国药准字H20255933 10ml:50mg Category B (乙) XL01XAA215B002020109910NHSA
健进制药有限公司 国药准字H20244822 10ml:50mg Category B (乙) XL01XAA215B002020181926NHSA
山东新时代药业有限公司 国药准字H20213541 20ml:100mg Category B (乙) XL01XAA215B002020204188NHSA
华夏生生药业(北京)有限公司 国药准字H20255933 10ml:50mg Category B (乙) XL01XAA215B002020209910NHSA
湖北一半天制药有限公司 国药准字H20265987 40ml:200mg Category B (乙) XL01XAA215B002030106932NHSA
华夏生生药业(北京)有限公司 国药准字H20255931 40ml∶200mg Category B (乙) XL01XAA215B002030109910NHSA
齐鲁制药(海南)有限公司 国药准字H20203218 40ml:0.2g Category B (乙) XL01XAA215B002030205847NHSA

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 2 distinct first applicants.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
合肥力成药业有限公司 CYHS2601692 Generic2026/07/15Not stated by sourceCDE
合肥力成药业有限公司 CYHS2601691 Generic2026/07/15Not stated by sourceCDE
哈尔滨三联药业股份有限公司 CYHS2602705 Generic2026/11/05Not stated by sourceCDE
哈尔滨三联药业股份有限公司 CYHS2602703 Generic2026/11/05Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
合肥力成药业有限公司 CYHS2601692 Generic2026/07/15Not stated by sourceCDE
合肥力成药业有限公司 CYHS2601691 Generic2026/07/15Not stated by sourceCDE
哈尔滨三联药业股份有限公司 CYHS2602705 Generic2026/11/05Not stated by sourceCDE
哈尔滨三联药业股份有限公司 CYHS2602703 Generic2026/11/05Not stated by sourceCDE
API registrations

Non-component matches: 26 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
奥沙利铂湖北一半天制药有限公司Y20210001223AExact ingredient2023/06/28CDE
奥沙利铂HERAEUS PRECIOUS METALS GMBH & CO. KGY20210001055AExact ingredient2025/09/24CDE
奥沙利铂Debiopharm International S.A.Y20200001275IExact ingredient2021/01/15CDE
奥沙利铂昆明贵研药业有限公司Y20190009875AExact ingredient2023/12/06CDE
奥沙利铂江苏恒瑞医药股份有限公司Y20190009632AExact ingredient2025/08/22CDE
奥沙利铂齐鲁制药有限公司Y20190009353AExact ingredient2025/02/27CDE
奥沙利铂先声药业有限公司Y20190007591AExact ingredient2024/04/29CDE
奥沙利铂远大医药黄石飞云制药有限公司Y20190007556AExact ingredient2024/08/17CDE
奥沙利铂无锡紫杉药业股份有限公司Y20190007479AExact ingredient2025/07/30CDE
奥沙利铂浙江海正药业股份有限公司Y20190007430AExact ingredient2023/09/09CDE
奥沙利铂扬子江药业集团江苏海慈生物药业有限公司Y20190007392AExact ingredient2023/10/13CDE
奥沙利铂山东罗欣药业集团恒欣药业有限公司Y20190006879AExact ingredient—CDE
奥沙利铂南京臣功制药股份有限公司Y20190006604AExact ingredient—CDE
奥沙利铂苏州立新制药有限公司Y20190006084AExact ingredient2026/02/25CDE
奥沙利铂重庆泰濠制药有限公司Y20190005513AExact ingredient—CDE
奥沙利铂成都长青制药有限公司Y20190004910AExact ingredient—CDE
奥沙利铂南京海润医药有限公司Y20190004758AExact ingredient2025/08/05CDE
奥沙利铂深圳海王药业有限公司Y20190004459AExact ingredient2024/12/25CDE
奥沙利铂南京制药厂有限公司Y20190004335AExact ingredient—CDE
奥沙利铂远大武药(江苏)制药有限公司Y20190001417AExact ingredient2025/06/29CDE
奥沙利铂费森尤斯卡比(武汉)医药有限公司Y20190001358AExact ingredient—CDE
奥沙利铂南京瑞年百思特制药有限公司Y20190001357AExact ingredient—CDE
奥沙利铂兰西哈三联制药有限公司Y20190001328AExact ingredient2024/06/06CDE
奥沙利铂UMICORE ARGENTINA S.A.Y20190000501AExact ingredient2026/01/05CDE
奥沙利铂齐鲁制药有限公司Y20180001626AExact ingredient2019/01/02CDE
奥沙利铂昆明贵研药业有限公司Y20180000346AExact ingredient2026/06/26CDE
奥沙利铂江苏恒瑞医药股份有限公司Y20170002037AExact ingredient2025/04/02CDE
奥沙利铂山东铂源药业股份有限公司Y20170000383AExact ingredient2024/04/16CDE
奥沙利铂Heraeus Precious Metals GmbH & Co. KGY20170000338IExact ingredient—CDE
奥沙利铂Fresenius Kabi Oncology LimitedY20170000229IExact ingredient—CDE
奥沙利铂上海创诺制药有限公司Y20170000110AExact ingredient2023/03/24CDE
奥沙利铂Shilpa Medicare LTDY20170000070AExact ingredient2024/07/18CDE

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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

  1. 2026/11/05Accepted

    哈尔滨三联药业股份有限公司

    CYHS2602705

    Fact date: 2026/11/05 · Site observation date: 2026/11/06

    View source ↗
  2. 2026/11/05Accepted

    哈尔滨三联药业股份有限公司

    CYHS2602703

    Fact date: 2026/11/05 · Site observation date: 2026/11/06

    View source ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/10 07:27
Chemical-drug catalogue
Last successful update: 2026/11/10 07:23

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: 2026/11/10 07:25
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: 2026/11/10 18:31

First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.

Drug Clinical Trial Registry and Information Disclosure Platform
Last successful update: 2026/11/10 08:10 · 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: 3/30; discovered pending details: 20. 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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