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Mesalazine Suppositories(美沙拉秦栓)

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

Last 90 days: Accepted: 1 application

Current coverage may be incomplete

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

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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: 6 distinct approval numbers and 5 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
浙江高跖医药科技股份有限公司 国药准字H20265439 0.5g Category B (乙) XA07ECM053D001010184221NHSA
浙江高跖医药科技股份有限公司 国药准字H20265439 0.5g Category B (乙) XA07ECM053D001010284221NHSA
浙江高跖医药科技股份有限公司 国药准字H20265439 0.5g Category B (乙) XA07ECM053D001010384221NHSA
上海爱的发制药有限公司 国药准字H20256026 1g Category B (乙) XA07ECM053D001010183683NHSA
黑龙江天宏药业股份有限公司 国药准字H20065650 1g Category B (乙) XA07ECM053D001010103789NHSA
Dr. Falk Pharma GmbH 国药准字HJ20140948 0.5g Category B (乙) XA07ECM053D001010178373NHSA
Ferring GmbH 国药准字HJ20160582 1g Category B (乙) XA07ECM053D001010178423NHSA
黑龙江天宏药业股份有限公司 国药准字H20065650 1g Category B (乙) XA07ECM053D001010203789NHSA
Ferring GmbH 国药准字HJ20160582 1g Category B (乙) XA07ECM053D001010278423NHSA
黑龙江天宏药业股份有限公司 国药准字H20065650 1g Category B (乙) XA07ECM053D001010303789NHSA
Dr. Falk Pharma GmbH H20150280 1g Category B (乙) XA07ECM053D001020178373NHSA

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.

Supplement 1 · Generic 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Ferring GmbH;Ferring International Center SA JYHB2600477 Supplement2026/08/18Not stated by sourceCDE
牡丹江恒远药业股份有限公司;浙江赛默制药有限公司 CYHS2601498 Generic2026/06/25Not stated by sourceCDE
黑龙江龙德药业有限公司;哈尔滨誉衡制药有限公司 CYHS2601194 Generic2026/05/26Not stated by sourceCDE
华东医药(西安)博华制药有限公司 CYHS2502620 Generic2025/07/22Not 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
牡丹江恒远药业股份有限公司;浙江赛默制药有限公司 CYHS2601498 Generic2026/06/25Not stated by sourceCDE
黑龙江龙德药业有限公司;哈尔滨誉衡制药有限公司 CYHS2601194 Generic2026/05/26Not stated by sourceCDE
API registrations

Non-component matches: 10 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
美沙拉秦CHEMI S.P.A.Y20250000643IExact ingredient2025/08/08CDE
美沙拉秦日照巴洛特药业有限公司Y20240000897IExact ingredient2024/11/25CDE
美沙拉秦Apitoria Pharma Private LimitedY20200000566AExact ingredient2025/06/09CDE
美沙拉秦BEC CHEMICALS PVT. LTD.Y20200000797AExact ingredient2026/06/02CDE
美沙拉秦牡丹江恒远药业股份有限公司Y20190009873AExact ingredient2024/09/24CDE
美沙拉秦Corden Pharma Bergamo S.p.A.Y20190009203AExact ingredient—CDE
美沙拉秦恒诚制药集团淮南有限公司Y20190001506AExact ingredient2024/07/18CDE
美沙拉秦浙江恒康药业股份有限公司Y20190000586AExact ingredient2025/07/04CDE
美沙拉秦牡丹江恒远药业股份有限公司Y20170001744IExact ingredient2019/01/14CDE
美沙拉秦SUN PHARMACEUTICAL INDUSTRIES LTD.Y20170001093AExact ingredient2024/12/13CDE
美沙拉秦CHEMI S.P.AY20170001053AExact ingredient2025/02/17CDE
美沙拉秦浙江三门恒康制药有限公司Y20170000253AExact ingredient2022/09/08CDE
美沙拉秦(S级)CAMBREX, KARLSKOGA ABY20170000108AExact ingredient2026/08/05CDE
美沙拉秦(SH级)CAMBREX, KARLSKOGA ABY20170000104AExact ingredient2026/08/05CDE

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. 2026/08/18Accepted

    Ferring GmbH;Ferring International Center SA

    JYHB2600477

    Fact date: 2026/08/18 · 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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