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Company directoryChina company filings

Shuang He Pharma (Hainan) 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 dbc0ee7077

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

17 acceptance records as first applicant, grouped into 12 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.

盐酸黄酮哌酯片 · No verified English name 1 records · Latest accepted 2026/09/15

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601730Supplement2026/09/15Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Albendazole Tablets 1 records · Latest accepted 2026/02/25

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600370Supplement2026/02/25Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
盐酸酚苄明片 · No verified English name 2 records · Latest accepted 2025/12/03

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2502467Supplement2025/12/03Shuang He Pharma (Hainan) Co., Ltd. romanized; Hua Run Shuang He Pharma Co., Ltd. romanizedCDE ↗
CYHB2501015Supplement2025/05/17Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Mycophenolate Mofetil for Injection 1 records · Latest accepted 2024/10/13

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2450516Supplement2024/10/13Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Linaclotide Capsules 2 records · Latest accepted 2024/10/09

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403334Generic2024/10/09Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
CYHS2201778Generic2022/10/19Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Vonoprazan Fumarate Tablets 2 records · Latest accepted 2024/01/04

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400028Generic2024/01/04Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
CYHS2400027Generic2024/01/04Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Tigecycline for Injection 1 records · Latest accepted 2023/10/18

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302792Generic2023/10/18Shuang He Pharma (Hainan) Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Omeprazole Sodium for Injection 2 records · Latest accepted 2023/07/11

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350542Supplement2023/07/11Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
CYHB2350541Supplement2023/07/11Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Clozapine Orally Disintegrating Tablets 1 records · Latest accepted 2023/01/17

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350071Supplement2023/01/17Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Roxatidine Acetate Hydrochloride For Injection 1 records · Latest accepted 2022/12/13

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2202066Generic2022/12/13Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Ganciclovir For Injection 2 records · Latest accepted 2022/09/08

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2250566Supplement2022/09/08Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
CYHB2250565Supplement2022/09/08Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Lansoprazole For Injection 1 records · Latest accepted 2022/01/11

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2250018Supplement2022/01/11Shuang He Pharma (Hainan) 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.

Accepted: 1 application

  1. 2026/09/15Accepted

    盐酸黄酮哌酯片 · No verified English name

    CYHB2601730

    Fact date: 2026/09/15 · Site observation date: 2026/10/22

    View source ↗

Under review

1 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
Linaclotide Capsules CYHS2403334Generic2024/10/09Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗

Catalogue holder records

11 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
Vonoprazan Fumarate TabletsShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H202551662025/08/19Generic approved under the new chemical-drug registration classificationCDE ↗
Vonoprazan Fumarate TabletsShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H202551672025/08/19Generic approved under the new chemical-drug registration classificationCDE ↗
Tigecycline for InjectionShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H202539272025/04/15Generic approved under the new chemical-drug registration classificationCDE ↗
Omeprazole Sodium for InjectionShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H200902332024/08/29Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Omeprazole Sodium for InjectionShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H200637352024/08/29Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Roxatidine Acetate Hydrochloride For InjectionShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H202440642024/06/18Generic approved under the new chemical-drug registration classificationCDE ↗
Ganciclovir For InjectionShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H200594702024/02/18Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Ganciclovir For InjectionShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H200594692024/02/18Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Clozapine Orally Disintegrating TabletsShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H201200812024/02/01Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Lansoprazole For InjectionShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H201400362023/05/10Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Mycophenolate Mofetil for InjectionShuang He Pharma (Hainan) Co., Ltd. romanizedShuang He Pharma (Hainan) Co., Ltd. romanized国药准字H200677452026/09/20Drug that passed quality-and-efficacy consistency evaluationCDE ↗

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

0 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
No matching records were found in the currently loaded source data; coverage dates are listed below.

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

10 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
Cetrorelix Acetate for Injection CYHS2500614Generic2025/02/07Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Esomeprazole Sodium for Injection CYHB2401084Supplement2024/07/20Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized; Hainan Zhong Yu Pharma Co., Ltd. romanizedCDE ↗
Esomeprazole Sodium for Injection CYHB2401083Supplement2024/07/20Zhong Yu Pharmaceutical (Haikou) Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized; Hainan Zhong Yu Pharma Co., Ltd. romanizedCDE ↗
Nicorandil for Injection CYHS2401820Generic2024/06/18Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Indocyaninegreen for Injection CYHS2401375Generic2024/05/09Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Esomeprazole Magnesium Enteric-Coated Capsules CYHS2301644Generic2023/06/16Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Esomeprazole Magnesium Enteric-Coated Capsules CYHS2301643Generic2023/06/16Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Rifampin For Injection CYHS2300624Generic2023/02/23Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
Nicorandil for Injection CYHS2201772Generic2022/10/19Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗
醋酸亮丙瑞林 · No verified English name JTH2100548Not stated by source2021/06/11PolyPeptide Laboratories Pvt. Ltd.; Shuang He Pharma (Hainan) Co., Ltd. romanizedCDE ↗

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.