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Milnacipran Hydrochloride Tablets(盐酸米那普仑片)

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

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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: 3 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 2 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
上海现代制药股份有限公司上海现代制药股份有限公司 国药准字H20247158 2024/07/10 50mg Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
河北龙海药业有限公司河北龙海药业有限公司 国药准字H20243552 2024/04/24 25mg 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
四川科瑞德制药股份有限公司四川科瑞德制药股份有限公司 国药准字H20234510 2023/11/21 25mg 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
上海现代制药股份有限公司上海现代制药股份有限公司 国药准字H20100052 2022/05/18 25mg Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) CDE
四川科瑞德制药股份有限公司四川科瑞德制药股份有限公司 国药准字H20269200 2026/08/11 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

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
上海现代制药股份有限公司 国药准字H20100052 25mg Category B (乙) XN06AXM103A001010100814NHSA
四川科瑞德制药股份有限公司 国药准字H20234510 25mg Category B (乙) XN06AXM103A001010102181NHSA
河北龙海药业股份有限公司 国药准字H20243552 25mg Category B (乙) XN06AXM103A001010102766NHSA
上海现代制药股份有限公司 国药准字H20100052 25mg Category B (乙) XN06AXM103A001010200814NHSA
四川科瑞德制药股份有限公司 国药准字H20234510 25mg Category B (乙) XN06AXM103A001010202181NHSA
河北龙海药业股份有限公司 国药准字H20243552 25mg Category B (乙) XN06AXM103A001010202766NHSA
上海现代制药股份有限公司 国药准字H20100052 25mg Category B (乙) XN06AXM103A001010300814NHSA
上海现代制药股份有限公司 国药准字H20247158 50mg Category B (乙) XN06AXM103A001020100814NHSA
上海现代制药股份有限公司 国药准字H20247158 50mg Category B (乙) XN06AXM103A001020200814NHSA

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: 8 filings and 5 distinct first applicants.

Generic 8

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
宁波美诺华天康药业有限公司 CYHS2602329 Generic2026/09/18Not stated by sourceCDE
宁波美诺华天康药业有限公司 CYHS2602328 Generic2026/09/18Not stated by sourceCDE
河北万龙药业有限公司;河北龙海药业股份有限公司 CYHS2601197 Generic2026/05/26Not stated by sourceCDE
河北万龙药业有限公司;河北龙海药业股份有限公司 CYHS2601196 Generic2026/05/26Not stated by sourceCDE
石家庄龙泽制药股份有限公司 CYHS2600858 Generic2026/04/14Not stated by sourceCDE
石家庄龙泽制药股份有限公司 CYHS2600857 Generic2026/04/14Not stated by sourceCDE
浙江华贝药业有限责任公司;乐普制药科技有限公司 CYHS2600586 Generic2026/02/28Not stated by sourceCDE
白云山东泰商丘药业有限公司 CYHS2503173 Generic2025/08/29Not stated by sourceCDE
New generic filings in 2026

Loaded records: 7 filings and 4 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
宁波美诺华天康药业有限公司 CYHS2602329 Generic2026/09/18Not stated by sourceCDE
宁波美诺华天康药业有限公司 CYHS2602328 Generic2026/09/18Not stated by sourceCDE
河北万龙药业有限公司;河北龙海药业股份有限公司 CYHS2601197 Generic2026/05/26Not stated by sourceCDE
河北万龙药业有限公司;河北龙海药业股份有限公司 CYHS2601196 Generic2026/05/26Not stated by sourceCDE
石家庄龙泽制药股份有限公司 CYHS2600858 Generic2026/04/14Not stated by sourceCDE
石家庄龙泽制药股份有限公司 CYHS2600857 Generic2026/04/14Not stated by sourceCDE
浙江华贝药业有限责任公司;乐普制药科技有限公司 CYHS2600586 Generic2026/02/28Not stated by sourceCDE
API registrations

Non-component matches: 5 companies with A status and 1 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸米那普仑江苏威奇达药业有限公司Y20240001096AExact ingredient2026/02/13CDE
盐酸米那普仑泸州科瑞德制药有限公司Y20210000829AExact ingredient2026/06/10CDE
盐酸米那普仑Glenmark Life Sciences LimitedY20200000968IExact ingredient2022/08/15CDE
盐酸米那普仑Hetero Labs LimitedY20190000779AExact ingredient2025/09/30CDE
盐酸米那普仑国药集团威奇达药业有限公司Y20190021586AExact ingredient2026/07/29CDE
盐酸米那普仑上海现代制药股份有限公司Y20190002147AExact 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

  1. 2026/10/27No longer listed under review

    四川宏明博思药业有限公司;四川科瑞德制药股份有限公司

    CYHB2601849

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

    Accepted: 2026/10/09

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/27 (approval no.: —; approval date: 2026/10/23); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 16

    NMPA · Table row 16 ↗ View source ↗
  2. 2026/10/27No longer listed under review

    四川宏明博思药业有限公司;四川科瑞德制药股份有限公司

    CYHB2601848

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

    Accepted: 2026/10/09

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/27 (approval no.: —; approval date: 2026/10/23); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 15

    NMPA · Table row 15 ↗ View source ↗
  3. 2026/10/23Supplement delivery

    四川宏明博思药业有限公司

    CYHB2601849

    Fact date: 2026/10/23 · Publication date: 2026/10/27 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 16 ↗
  4. 2026/10/23Supplement delivery

    四川宏明博思药业有限公司

    CYHB2601848

    Fact date: 2026/10/23 · Publication date: 2026/10/27 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 15 ↗
  5. 2026/10/09Accepted

    四川宏明博思药业有限公司;四川科瑞德制药股份有限公司

    CYHB2601849

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

    View source ↗
  6. 2026/10/09Accepted

    四川宏明博思药业有限公司;四川科瑞德制药股份有限公司

    CYHB2601848

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

    View source ↗
  7. 2026/09/18Accepted

    宁波美诺华天康药业有限公司

    CYHS2602329

    Fact date: 2026/09/18 · Site observation date: 2026/10/22

    View source ↗
  8. 2026/09/18Accepted

    宁波美诺华天康药业有限公司

    CYHS2602328

    Fact date: 2026/09/18 · Site observation date: 2026/10/22

    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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