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Company directoryChina company filings

Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanized

Check drug filings and source records for this company-name string.

Listed by the company name as recorded in the source, without merging affiliated entities.

Page reference d4c21a8cfa

Complete CDE snapshot
2026/11/13 06:42
Matching scope
Loaded public-source records only

These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/13 06:42.

Drug filings

25 acceptance records as first applicant, grouped into 16 source drug names. Source data as of 2026/11/13 06:42.

Acceptance records are de-duplicated by acceptance number. Drug names are normalized only for width and whitespace; dosage forms and combinations remain separate. Application types are retained from the source. Expand a drug to inspect each record. Published drugs link to their drug pages; other names do not create new public drug pages.

Emedastine Difumarate Sustained-release Capsules 2 records · Latest accepted 2026/06/18

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601452Generic2026/06/18Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2601451Generic2026/06/18Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
腺苷钴胺胶囊 · No verified English name 2 records · Latest accepted 2026/06/10

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601084Supplement2026/06/10Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2401296Generic2024/04/29Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Esomeprazole Magnesium Enteric-Coated Capsules 2 records · Latest accepted 2026/04/22

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600920Generic2026/04/22Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2600919Generic2026/04/22Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Fexofenadine Hydrochloride Oral Suspension 1 records · Latest accepted 2026/02/27

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600563Generic2026/02/27Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Benidipine Hydrochloride Tablets 1 records · Latest accepted 2025/10/17

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503722Generic2025/10/17Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Candesartan Cilexetil and Hydrochlorothiazide Tablets 1 records · Latest accepted 2025/04/30

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501617Generic2025/04/30Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Lansoprazole Enteric Capsules 2 records · Latest accepted 2025/03/14

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500525Supplement2025/03/14Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2301600Generic2023/06/12Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
盐酸非索非那定干混悬剂 · No verified English name 2 records · Latest accepted 2025/01/15

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500300Generic2025/01/15Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2500298Generic2025/01/15Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Perindopril Arginine and Amlodipine Besylate Tablets(III) 1 records · Latest accepted 2024/09/25

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403160Generic2024/09/25Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Terbinafine Hydrochloride Cream 1 records · Latest accepted 2024/09/13

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2401458Supplement2024/09/13Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Metoprolol Succinate Extended-release Capsules 2 records · Latest accepted 2024/08/08

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402530Generic2024/08/08Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2402529Generic2024/08/08Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Acetylcysteine Granules 4 records · Latest accepted 2023/07/12

Supplement · 3Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2301557Supplement2023/07/12Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2301317Supplement2023/06/12Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2300306Supplement2023/02/16Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2101420Generic2021/07/08Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
磷霉素氨丁三醇颗粒 · No verified English name 1 records · Latest accepted 2023/04/27

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2301185Generic2023/04/27Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Fluvoxamine Maleate Tablets 1 records · Latest accepted 2022/09/29

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201633Generic2022/09/29Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Omeprazole Enteric Capsules 1 records · Latest accepted 2021/07/16

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2150739Supplement2021/07/16Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Valsartan Capsules 1 records · Latest accepted 2021/02/22

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2100218Generic2021/02/22Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

1 events from 2026/08/16 to 2026/11/13. CDE data as of 2026/11/13 06:42; NMPA data as of 2026/11/12 18:32.

This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately. 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.

No longer listed under review: 1 application

  1. 2026/10/29No longer listed under review

    Candesartan Cilexetil and Hydrochlorothiazide Tablets

    CYHS2501617

    Fact date: 2026/10/29 · Site observation date: 2026/10/29

    Accepted: 2025/04/30

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗

Under review

7 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/13 06:42.

Under review
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
Emedastine Difumarate Sustained-release Capsules CYHS2601452Generic2026/06/18Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Emedastine Difumarate Sustained-release Capsules CYHS2601451Generic2026/06/18Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
腺苷钴胺胶囊 · No verified English name CYHB2601084Supplement2026/06/10Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Esomeprazole Magnesium Enteric-Coated Capsules CYHS2600920Generic2026/04/22Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Esomeprazole Magnesium Enteric-Coated Capsules CYHS2600919Generic2026/04/22Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Fexofenadine Hydrochloride Oral Suspension CYHS2600563Generic2026/02/27Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗
Benidipine Hydrochloride Tablets CYHS2503722Generic2025/10/17Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedCDE ↗

Catalogue holder records

10 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/13 06:39. Manufacturer-only records are excluded.

DrugMarketing authorization holderManufacturerApproval numberApprovedCatalogue category (source text)View source
Perindopril Arginine and Amlodipine Besylate Tablets(III)Gui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202633482026/02/02Generic approved under the new chemical-drug registration classificationCDE ↗
Metoprolol Succinate Extended-release CapsulesGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202562692025/12/16Generic approved under the new chemical-drug registration classificationCDE ↗
Metoprolol Succinate Extended-release CapsulesGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202562702025/12/16Generic approved under the new chemical-drug registration classificationCDE ↗
腺苷钴胺胶囊 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202551852025/08/26Other drugCDE ↗
Lansoprazole Enteric CapsulesGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202449092024/09/19Generic approved under the new chemical-drug registration classificationCDE ↗
Fluvoxamine Maleate TabletsGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202435382024/04/17Generic approved under the new chemical-drug registration classificationCDE ↗
Acetylcysteine GranulesGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202238422022/11/15Generic approved under the new chemical-drug registration classificationCDE ↗
Omeprazole Enteric CapsulesGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H201432042022/06/21Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Valsartan CapsulesGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202232402022/04/19Generic approved under the new chemical-drug registration classificationCDE ↗
Venlafaxine Hydrochloride Sustained-Release CapsulesGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedGui Lin Hua Xin Pharmaceutical Co., Ltd. romanized国药准字H202230352022/01/30Generic approved under the new chemical-drug registration classificationCDE ↗

Only active catalogue records matching the source holder name are listed. A manufacturer role does not count as a holder record. The catalogue covers only part of the chemical-drug market; source categories do not establish complete market coverage or qualifications.

API registrations

17 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/13 06:41.

NameCompany / applicantRegistration numberStatusSource update dateView source
右兰索拉唑 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20260000845I2026/10/21CDE ↗
盐酸贝尼地平 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20250001017I2025/09/24CDE ↗
雷贝拉唑钠 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20240000625A2025/12/18CDE ↗
琥珀酸美托洛尔 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20230000348A2026/03/12CDE ↗
艾司奥美拉唑镁 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20200001423A2026/06/02CDE ↗
盐酸文拉法辛 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20190009845A2024/08/23CDE ↗
奥美拉唑钠 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20190009696A2024/09/27CDE ↗
兰索拉唑 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20190008644A2024/09/21CDE ↗
奥美拉唑 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20190008084A2024/09/21CDE ↗
泮托拉唑钠 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20190006133A2024/09/21CDE ↗
酮康唑 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20190006132A2025/01/01CDE ↗
磷霉素氨丁三醇 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20190005284A2024/09/21CDE ↗
胶体果胶铋 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20190001385A2025/01/01CDE ↗
奥美拉唑钠 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20190000169I2019/04/01CDE ↗
兰索拉唑 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20180001274A2025/12/31CDE ↗
盐酸文拉法辛 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20180000005I2019/01/14CDE ↗
马来酸氟伏沙明 · No verified English nameGui Lin Hua Xin Pharmaceutical Co., Ltd. romanizedY20170001375A2026/06/02CDE ↗

Only loaded active API registrations not listed as cancelled are shown. A/I are source registration statuses. Records are listed by registration number and do not establish capacity or supply. The register does not identify the associated formulation.

Co-applicant records

0 acceptance records name this company after the first applicant. They are listed separately and are not included in first-applicant drug or filing counts. Source data as of 2026/11/13 06:42.

Co-applicant records
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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
Full API register
Last successful update: 2026/11/13 06:41
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.

Listed by the company name as recorded in the source, without merging affiliated entities.

This page summarizes loaded records only, without new source queries or collection. Parent companies, subsidiaries, former names and aliases are not merged. Counts from different sources must not be added together. No loaded record does not establish the absence of a filing or registration. Check original records where coverage is incomplete, an update has failed, or a source lies outside the loaded scope.

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.

Drugs with a verified official English name use that name only. Other drug names retain the Chinese source name marked No verified English name; names with a Chinese public page link to that page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized; Chinese company names are not displayed. Marked unverified drug names and original statutory reference numbers may appear in Chinese.

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.