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Hainan Feng Kai Si 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 0857f8af29

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 20 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.

注射用头孢唑肟钠 · No verified English name 2 records · Latest accepted 2026/09/30

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601829Supplement2026/09/30Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Fujian Sheng Fu Kang Pharma Co., Ltd. romanizedCDE ↗
CYHB2601828Supplement2026/09/30Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Fujian Sheng Fu Kang Pharma Co., Ltd. romanizedCDE ↗
腺苷钴胺胶囊 · No verified English name 1 records · Latest accepted 2026/07/07

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601283Supplement2026/07/07Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanizedCDE ↗
Diprophylline Injection 1 records · Latest accepted 2026/06/25

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601196Supplement2026/06/25Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCDE ↗
Ceftazidime And Avibactam Sodium For Injection 1 records · Latest accepted 2026/06/04

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601056Supplement2026/06/04Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Fujian Sheng Fu Kang Pharma Co., Ltd. romanizedCDE ↗
Mupirocin Ointment 1 records · Latest accepted 2026/05/08

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601044Generic2026/05/08Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanizedCDE ↗
Famotidine Injection 1 records · Latest accepted 2025/12/03

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2502469Supplement2025/12/03Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCDE ↗
Chlorphenamine Maleate Injection 1 records · Latest accepted 2025/12/03

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2502470Supplement2025/12/03Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCDE ↗
Amikacin Sulfate injection 1 records · Latest accepted 2025/09/25

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501900Supplement2025/09/25Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanizedCDE ↗
Oxacillin Sodium for Injection 1 records · Latest accepted 2025/08/27

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501697Supplement2025/08/27Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Ampicillin Sodium For Injection 1 records · Latest accepted 2025/08/26

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501691Supplement2025/08/26Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
Morinidazole and Sodium Chloride Injection 1 records · Latest accepted 2025/07/22

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2502642Generic2025/07/22Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
尼麦角林注射液 · No verified English name 3 records · Latest accepted 2025/07/01

Supplement · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501294Supplement2025/07/01Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2501293Supplement2025/07/01Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2501292Supplement2025/07/01Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
注射用天麻素 · No verified English name 1 records · Latest accepted 2025/06/28

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501279Supplement2025/06/28Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Ozagrel Sodium Injection 2 records · Latest accepted 2025/06/27

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501260Supplement2025/06/27Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2501259Supplement2025/06/27Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Latamoxef Sodium for Injection 1 records · Latest accepted 2025/05/30

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501107Supplement2025/05/30Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanizedCDE ↗
Parecoxib Sodium for Injection 1 records · Latest accepted 2025/05/23

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501059Supplement2025/05/23Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Jiangsu Jin Si Li Pharma Co., Ltd. romanizedCDE ↗
Piperacillin Sodium for Injection 2 records · Latest accepted 2025/05/16

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500995Supplement2025/05/16Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2500994Supplement2025/05/16Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Jiangsu Hai Hong Pharmaceutical Co., Ltd. romanizedCDE ↗
Ambroxol Hydrochloride Oral Solution 1 records · Latest accepted 2025/05/09

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500935Supplement2025/05/09Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanizedCDE ↗
索法酮颗粒 · No verified English name 1 records · Latest accepted 2025/05/08

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501652Generic2025/05/08Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanizedCDE ↗
Imipenem and Cilastatin Sodium for Injection 1 records · Latest accepted 2025/04/09

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501360Generic2025/04/09Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

6 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: 2 applicationsNo longer listed under review: 2 applicationsSupplement delivery: 2 applications

  1. 2026/10/28No longer listed under review

    注射用头孢唑肟钠 · No verified English name

    CYHB2601829

    Fact date: 2026/10/28 · Site observation date: 2026/10/28

    Accepted: 2026/09/30

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/28 (approval no.: —; approval date: 2026/10/26); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 6

    NMPA · Table row 6 ↗ View source ↗
  2. 2026/10/28No longer listed under review

    注射用头孢唑肟钠 · No verified English name

    CYHB2601828

    Fact date: 2026/10/28 · Site observation date: 2026/10/28

    Accepted: 2026/09/30

    not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/28 (approval no.: —; approval date: 2026/10/26); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 5

    NMPA · Table row 5 ↗ View source ↗
  3. 2026/10/26Supplement delivery

    注射用头孢唑肟钠 · No verified English name

    CYHB2601829

    Fact date: 2026/10/26 · Publication date: 2026/10/28 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 6 ↗
  4. 2026/10/26Supplement delivery

    注射用头孢唑肟钠 · No verified English name

    CYHB2601828

    Fact date: 2026/10/26 · Publication date: 2026/10/28 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 5 ↗
  5. 2026/09/30Accepted

    注射用头孢唑肟钠 · No verified English name

    CYHB2601829

    Fact date: 2026/09/30 · Site observation date: 2026/10/22

    View source ↗
  6. 2026/09/30Accepted

    注射用头孢唑肟钠 · No verified English name

    CYHB2601828

    Fact date: 2026/09/30 · Site observation date: 2026/10/22

    View source ↗

Under review

4 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
Mupirocin Ointment CYHS2601044Generic2026/05/08Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanizedCDE ↗
Morinidazole and Sodium Chloride Injection CYHS2502642Generic2025/07/22Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedCDE ↗
索法酮颗粒 · No verified English name CYHS2501652Generic2025/05/08Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanizedCDE ↗
Imipenem and Cilastatin Sodium for Injection CYHS2501360Generic2025/04/09Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Shenzhen Shi Hai Bin Pharmaceutical Co., Ltd. romanizedCDE ↗

Catalogue holder records

3 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
Oxacillin Sodium for InjectionHainan Feng Kai Si Pharmaceutical Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202651432026/07/14Generic approved under the new chemical-drug registration classificationCDE ↗
Latamoxef Sodium for InjectionHainan Feng Kai Si Pharmaceutical Co., Ltd. romanizedHaerbin Yu Heng Pharmaceutical Co., Ltd. romanized国药准字H202638232026/04/07Generic approved under the new chemical-drug registration classificationCDE ↗
Ampicillin Sodium For InjectionHainan Feng Kai Si Pharmaceutical Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202637122026/03/25Generic 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.