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Hainan Zhuo Ke 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 6ef81cfae7

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

27 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.

Sodium Thiosulfate Injection 1 records · Latest accepted 2025/05/01

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501634Generic2025/05/01Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CDE ↗
Methotrexate Tablets 1 records · Latest accepted 2025/02/07

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500619Generic2025/02/07Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Hainan Ri Zhong Tian Pharmaceutical Co., Ltd. romanizedCDE ↗
Amiodarone Hydrochloride Injection 1 records · Latest accepted 2025/01/28

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500556Generic2025/01/28Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCDE ↗
Sulpiride Injection 4 records · Latest accepted 2025/01/22

Generic · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500405Generic2025/01/22Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2500404Generic2025/01/22Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2401731Generic2024/06/08Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2401730Generic2024/06/08Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedCDE ↗
Ketorolac Tromethamine Injection 1 records · Latest accepted 2024/09/25

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403204Generic2024/09/25Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedCDE ↗
Fluorouracil Injection 2 records · Latest accepted 2024/08/03

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2401188Supplement2024/08/03Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
CYHS2201842Generic2022/10/28Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Haikou Shi Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Nitroglycerin Sublingual Tablets 2 records · Latest accepted 2024/07/23

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2450388Supplement2024/07/23Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanizedCDE ↗
CYHB2202026Supplement2022/11/04Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanizedCDE ↗
Carbazochrome Sodium Sulfonate Injection 2 records · Latest accepted 2024/07/18

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402251Generic2024/07/18Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2402250Generic2024/07/18Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanizedCDE ↗
Levocarnitine Injection 1 records · Latest accepted 2024/07/12

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402155Generic2024/07/12Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedCDE ↗
Bumetanide Injection 2 records · Latest accepted 2024/06/29

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401952Generic2024/06/29Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2401951Generic2024/06/29Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedCDE ↗
Levocarnitine Oral Solution 1 records · Latest accepted 2024/06/19

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401828Generic2024/06/19Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanizedCDE ↗
Furosemide Tablets 1 records · Latest accepted 2022/11/04

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2202027Supplement2022/11/04Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanizedCDE ↗
Sulpiride Tablets 1 records · Latest accepted 2022/11/04

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2202025Supplement2022/11/04Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanizedCDE ↗
Paclitaxel Injection 4 records · Latest accepted 2021/10/11

Supplement · 4

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2101951Supplement2021/10/11Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Hainan Zhuo Tai Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2101950Supplement2021/10/11Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Hainan Zhuo Tai Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2101949Supplement2021/10/11Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Hainan Zhuo Tai Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2101948Supplement2021/10/11Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Hainan Zhuo Tai Pharmaceutical Co., Ltd. romanizedCDE ↗
Ifosfamide For Injection 2 records · Latest accepted 2021/09/03

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2101771Supplement2021/09/03Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Hainan Zhuo Tai Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2101770Supplement2021/09/03Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Hainan Zhuo Tai Pharmaceutical Co., Ltd. romanizedCDE ↗
注射用福莫司汀 · No verified English name 1 records · Latest accepted 2021/09/02

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2101765Supplement2021/09/02Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized; Hainan Zhuo Tai 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.

Notification delivery: 1 application

  1. 2026/10/21Notification delivery

    Sodium Thiosulfate Injection

    CYHS2501634

    Fact date: 2026/10/21 (Publication date) · Publication date: 2026/10/21 · Site observation date: 2026/11/03

    Notification delivered; the specific outcome remains to be checked.

    View source · Table row 7 ↗

Under review

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

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
Sulpiride InjectionHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedHainan Zhuo Ke Pharmaceutical Co., Ltd. romanized国药准字H202659762026/09/15Generic approved under the new chemical-drug registration classificationCDE ↗
Sulpiride InjectionHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedHainan Zhuo Ke Pharmaceutical Co., Ltd. romanized国药准字H202659752026/09/15Generic approved under the new chemical-drug registration classificationCDE ↗
Carbazochrome Sodium Sulfonate InjectionHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedChengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H202659112026/09/08Generic approved under the new chemical-drug registration classificationCDE ↗
Carbazochrome Sodium Sulfonate InjectionHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedChengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized国药准字H202659102026/09/08Generic approved under the new chemical-drug registration classificationCDE ↗
Ketorolac Tromethamine InjectionHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedHainan Zhuo Ke Pharmaceutical Co., Ltd. romanized国药准字H202637112026/03/25Generic approved under the new chemical-drug registration classificationCDE ↗
Bumetanide InjectionHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedHainan Zhuo Ke Pharmaceutical Co., Ltd. romanized国药准字H202630112026/01/05Generic approved under the new chemical-drug registration classificationCDE ↗
Bumetanide InjectionHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedHainan Zhuo Ke Pharmaceutical Co., Ltd. romanized国药准字H202630122026/01/05Generic approved under the new chemical-drug registration classificationCDE ↗
Levocarnitine InjectionHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedHainan Zhuo Ke Pharmaceutical Co., Ltd. romanized国药准字H202562952025/12/16Generic approved under the new chemical-drug registration classificationCDE ↗
Nitroglycerin Sublingual TabletsHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedShijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized国药准字 H440239872025/06/16Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Fluorouracil InjectionHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedHaikou Shi Pharmaceutical Factory Co., Ltd. romanized国药准字H202580732025/05/06Generic 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

26 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
环磷腺苷 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20250000900I2025/09/02CDE ↗
呋塞米 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20240001396A2026/06/11CDE ↗
盐酸洛贝林 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20240000981A2026/07/20CDE ↗
盐酸胺碘酮 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20240000433A2026/04/21CDE ↗
盐酸甲氧氯普胺 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20240000350A2026/09/11CDE ↗
布美他尼 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20230001090A2025/07/18CDE ↗
左卡尼汀 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20230000689A2025/04/16CDE ↗
盐酸多巴酚丁胺 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20230000204A2025/04/24CDE ↗
重酒石酸间羟胺 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20230000209A2025/04/23CDE ↗
尼可刹米 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20230000183A2025/01/27CDE ↗
重酒石酸去甲肾上腺素 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20220001319A2024/07/17CDE ↗
氟尿嘧啶 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20210000705A2024/12/31CDE ↗
氯雷他定 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190007772A2025/03/07CDE ↗
安吖啶 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190007329A2023/12/07CDE ↗
头孢孟多酯钠 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190006824A2023/03/24CDE ↗
吗替麦考酚酯 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190006157A2026/02/25CDE ↗
葡萄糖酸依诺沙星 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190002867A2025/03/29CDE ↗
单磷酸阿糖腺苷 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190002850A2025/04/17CDE ↗
氨曲南 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190001957A2025/03/07CDE ↗
酮咯酸氨丁三醇 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190001956A2025/06/06CDE ↗
卡络磺钠 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190001910A2025/02/27CDE ↗
舒必利 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190001888A2025/03/13CDE ↗
泛影酸 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190001837A2025/04/03CDE ↗
葡甲胺 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190001834A2025/04/12CDE ↗
磷酸肌酸钠 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20170001006A2024/03/01CDE ↗
匹伐他汀钙 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20170000919A2023/07/10CDE ↗

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.