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Company directoryChina company filings

Hainan Hai He 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 99a205d1cd

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

11 acceptance records as first applicant, grouped into 10 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.

Polaprezinc Granules 1 records · Latest accepted 2026/11/12

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2602058Supplement2026/11/12Hainan Hai He Pharmaceutical Co., Ltd. romanized; Anhui Jia He Pharma Co., Ltd. romanizedCDE ↗
Diacerein Capsules 1 records · Latest accepted 2026/09/09

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601710Supplement2026/09/09Hainan Hai He Pharmaceutical Co., Ltd. romanized; Anhui Jia He Pharma Co., Ltd. romanizedCDE ↗
Cinitapride Hydrogen Tartrate Tablets 1 records · Latest accepted 2026/07/03

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601257Supplement2026/07/03Hainan Hai He Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanizedCDE ↗
Clemastine Fumarate Injection 1 records · Latest accepted 2026/06/15

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601125Supplement2026/06/15Hainan Hai He Pharmaceutical Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanizedCDE ↗
维生素B12注射液 · No verified English name 1 records · Latest accepted 2025/05/17

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501802Generic2025/05/17Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Rivastigmine Hydrogen Tartrate Oral Solution 2 records · Latest accepted 2025/03/29

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501227Generic2025/03/29Hainan Hai He Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CDE ↗
CYHS2501226Generic2025/03/29Hainan Hai He Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CDE ↗
Sodium Nitroprusside Injection 1 records · Latest accepted 2025/03/25

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501159Generic2025/03/25Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Potassium Chloride Granules 1 records · Latest accepted 2025/01/27

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500215Supplement2025/01/27Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
维生素B6注射液 · No verified English name 1 records · Latest accepted 2024/10/11

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403357Generic2024/10/11Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
氟尿嘧啶片 · No verified English name 1 records · Latest accepted 2021/12/06

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2102234Supplement2021/12/06Hainan Hai He Pharmaceutical Co., Ltd. romanized; Anhui Guo Sen Pharma Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

4 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.

Marketing application approved: 1 applicationAccepted: 2 applicationsSupplement delivery: 1 application

  1. 2026/11/12Accepted

    Polaprezinc Granules

    CYHB2602058

    Fact date: 2026/11/12 · Site observation date: 2026/11/13

    View source ↗
  2. 2026/10/20Supplement delivery

    Clemastine Fumarate Injection

    CYHB2601125 · 国药准字H20266370

    Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 9 ↗
  3. 2026/10/20Marketing application approved

    Clemastine Fumarate Injection

    CYHS2403599 · 国药准字H20266370

    Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03

    View source · Table row 9 ↗
  4. 2026/09/09Accepted

    Diacerein Capsules

    CYHB2601710

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

    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
Polaprezinc Granules CYHB2602058Supplement2026/11/12Hainan Hai He Pharmaceutical Co., Ltd. romanized; Anhui Jia He Pharma Co., Ltd. romanizedCDE ↗
Diacerein Capsules CYHB2601710Supplement2026/09/09Hainan Hai He Pharmaceutical Co., Ltd. romanized; Anhui Jia He Pharma Co., Ltd. romanizedCDE ↗
Cinitapride Hydrogen Tartrate Tablets CYHB2601257Supplement2026/07/03Hainan Hai He Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanizedCDE ↗
维生素B12注射液 · No verified English name CYHS2501802Generic2025/05/17Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Rivastigmine Hydrogen Tartrate Oral Solution CYHS2501227Generic2025/03/29Hainan Hai He Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CDE ↗
Rivastigmine Hydrogen Tartrate Oral Solution CYHS2501226Generic2025/03/29Hainan Hai He Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.CDE ↗
Sodium Nitroprusside Injection CYHS2501159Generic2025/03/25Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗

Catalogue holder records

1 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
维生素B6注射液 · No verified English nameHainan Hai He Pharmaceutical Co., Ltd. romanizedHainan Ling Kang Pharmaceutical Co., Ltd. romanized国药准字H202645732026/05/27Generic 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

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

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.