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Company directoryChina company filings

Zhi He (Shandong) Da Pharmaceutical Factory 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 9752bcd8ff

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

21 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.

Mannitol-S Injection 1 records · Latest accepted 2026/11/05

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2602013Supplement2026/11/05Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanizedCDE ↗
Foscarnet Sodium Injection 1 records · Latest accepted 2026/09/08

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2601701Supplement2026/09/08Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanizedCDE ↗
磷酸二氢钠磷酸氢二钠颗粒 · No verified English name 1 records · Latest accepted 2026/08/20

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2602070Generic2026/08/20Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
Sodium Thiosulfate Injection 1 records · Latest accepted 2025/07/15

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2502527Generic2025/07/15Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Bromhexine Hydrochloride Oral Solution 1 records · Latest accepted 2025/07/09

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2501348Supplement2025/07/09Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
盐酸甲氧氯普胺口服溶液 · No verified English name 1 records · Latest accepted 2025/04/22

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501512Generic2025/04/22Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Ebastine Oral Solution 1 records · Latest accepted 2025/03/18

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500548Supplement2025/03/18Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Terlipressin for Injection 1 records · Latest accepted 2025/03/18

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500545Supplement2025/03/18Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
盐酸丙卡特罗吸入溶液 · No verified English name 1 records · Latest accepted 2025/03/18

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500544Supplement2025/03/18Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Alendronate Sodium Oral Solution 1 records · Latest accepted 2025/03/18

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500547Supplement2025/03/18Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Potassium Phosphates Injection 1 records · Latest accepted 2025/03/17

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500540Supplement2025/03/17Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Tobramycin Eye Drops 1 records · Latest accepted 2025/03/17

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500542Supplement2025/03/17Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Pranoprofen Eye Drops 1 records · Latest accepted 2025/03/17

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500543Supplement2025/03/17Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Potassium Aspartate Injection 1 records · Latest accepted 2025/03/17

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500541Supplement2025/03/17Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Polyvinyl Alcohol Eye Drops 1 records · Latest accepted 2024/10/01

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403330Generic2024/10/01Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
西甲硅油乳剂 · No verified English name 1 records · Latest accepted 2023/02/08

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300397Generic2023/02/08Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
Levofloxacin Injection 1 records · Latest accepted 2022/10/10

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2201838Supplement2022/10/10Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCDE ↗
Lornoxicam for Injection 1 records · Latest accepted 2022/09/02

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201438Generic2022/09/02Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanizedCDE ↗
Tranexamic Acid Injection 1 records · Latest accepted 2021/09/18

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101760Generic2021/09/18Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCDE ↗
Ornidazole Injection 2 records · Latest accepted 2021/08/17

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101599Generic2021/08/17Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCDE ↗
CYHS2101598Generic2021/08/17Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

3 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: 3 applications

  1. 2026/11/05Accepted

    Mannitol-S Injection

    CYHB2602013

    Fact date: 2026/11/05 · Site observation date: 2026/11/06

    View source ↗
  2. 2026/09/08Accepted

    Foscarnet Sodium Injection

    CYHB2601701

    Fact date: 2026/09/08 · Site observation date: 2026/10/22

    View source ↗
  3. 2026/08/20Accepted

    磷酸二氢钠磷酸氢二钠颗粒 · No verified English name

    CYHS2602070

    Fact date: 2026/08/20 · 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
Mannitol-S Injection CYHB2602013Supplement2026/11/05Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hainan Ai Ke Pharmaceutical Co., Ltd. romanizedCDE ↗
Foscarnet Sodium Injection CYHB2601701Supplement2026/09/08Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanizedCDE ↗
磷酸二氢钠磷酸氢二钠颗粒 · No verified English name CYHS2602070Generic2026/08/20Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCDE ↗
盐酸甲氧氯普胺口服溶液 · No verified English name CYHS2501512Generic2025/04/22Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗

Catalogue holder records

6 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
Potassium Aspartate InjectionZhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedZhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized国药准字H202646172026/06/03Generic approved under the new chemical-drug registration classificationCDE ↗
Terlipressin for InjectionZhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedZhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized国药准字H202645412026/05/27Generic approved under the new chemical-drug registration classificationCDE ↗
Potassium Phosphates InjectionZhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedZhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized国药准字H202642062026/04/29Generic approved under the new chemical-drug registration classificationCDE ↗
Ornidazole InjectionZhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedChengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202238382022/11/08Generic approved under the new chemical-drug registration classificationCDE ↗
Ornidazole InjectionZhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedChengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202238372022/11/08Generic approved under the new chemical-drug registration classificationCDE ↗
Tranexamic Acid InjectionZhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedChengdu Shi Hai Tong Pharma Co., Ltd. romanized国药准字H202238392022/11/08Generic 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

26 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
Acetylcysteine Oral Solution CYHS2602277Generic2026/09/15Zhejiang Qian Jin Pharma Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Potassium Phosphates Injection CYHB2601253Supplement2026/07/02HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Polyvinyl Alcohol Eye Drops CYHS2600963Generic2026/04/25Shanghai Xiao Fang Pharmaceutical Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Amisulpride Oral Solution CYHS2503000Generic2025/08/16Hebei Yi Hai Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Potassium Phosphates Injection CYHB2501339Supplement2025/07/08Xizang Zhu Feng Shou Gao Bio Pharma Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Bilastine Oral Solution CYHS2502060Generic2025/06/11Nanjing Huang Long Bio Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Polyvinyl Alcohol Eye Drops CYHB2500943Supplement2025/05/10Jiangsu Jin Si Li Pharma Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
苯磺酸氨氯地平口服溶液 · No verified English name CYHS2501327Generic2025/04/08Shandong Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution CYHB2500577Supplement2025/03/21Hebei Jin Yi He Bio Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
氧氟沙星滴耳液 · No verified English name CYHS2404382Generic2024/12/17Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Potassium Phosphates Injection CYHS2402537Generic2024/08/09Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Potassium Aspartate Injection CYHS2402363Generic2024/07/26Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Ebastine Oral Solution CYHS2402348Generic2024/07/26Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Potassium Aspartate Injection CYHS2402191Generic2024/07/16Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Potassium Phosphates Injection CYHS2402065Generic2024/07/08Shijiazhuang Di Si Kai Wei Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Terlipressin for Injection CYHS2402033Generic2024/07/05Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Potassium Phosphates Injection CYHS2401998Generic2024/07/03Yi Yao Tong (Hebei) Bio Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Tobramycin Eye Drops CYHS2401965Generic2024/07/02Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Pranoprofen Eye Drops CYHS2401898Generic2024/06/26Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
醋酸来法莫林注射用浓溶液 · No verified English name CYHS2401817Generic2024/06/18Zhu You Pharmaceutical (Suzhou) Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
盐酸丙卡特罗吸入溶液 · No verified English name CYHS2401777Generic2024/06/13Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Procaterol Hydrochloride Solution for Inhalation CYHS2401557Generic2024/05/24Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Alendronate Sodium Oral Solution CYHS2401335Generic2024/05/07Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Bromhexine Hydrochloride Oral Solution CYHS2401117Generic2024/04/16Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution CYHS2401102Generic2024/04/13Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanizedCDE ↗
Loxoprofen Sodium Oral Solution CYHS2400913Generic2024/03/26Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory 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.