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Suzhou Lang Ke Bio Technology 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 1180f21e8c

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

34 acceptance records as first applicant, grouped into 26 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.

Scopolamine Butylbromide Injection 2 records · Latest accepted 2026/11/10

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2602035Supplement2026/11/10Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2402331Generic2024/07/24Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCDE ↗
Doxycycline Hyclate Tablets 2 records · Latest accepted 2026/01/23

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600143Supplement2026/01/23Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2600142Supplement2026/01/23Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanizedCDE ↗
Calcitriol Injection 1 records · Latest accepted 2025/12/19

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2502542Supplement2025/12/19Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanizedCDE ↗
Sulindac Tablets 1 records · Latest accepted 2025/08/26

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2503125Generic2025/08/26Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanizedCDE ↗
Erythromycin Lactobionate for Injection 2 records · Latest accepted 2025/07/12

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2502490Generic2025/07/12Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCDE ↗
CYHS2502489Generic2025/07/12Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCDE ↗
Doxycycline Hyclate for Injection 1 records · Latest accepted 2025/05/16

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501777Generic2025/05/16Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCDE ↗
Polidocanol Injection 3 records · Latest accepted 2025/03/29

Generic · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501225Generic2025/03/29Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2501224Generic2025/03/29Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2501223Generic2025/03/29Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCDE ↗
Progesterone Soft Capsules 1 records · Latest accepted 2025/03/19

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501103Generic2025/03/19Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedCDE ↗
Sodium Thiosulfate Injection 2 records · Latest accepted 2025/03/04

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500905Generic2025/03/04Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanizedCDE ↗
CYHS2500904Generic2025/03/04Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanizedCDE ↗
Fluorescein Sodium Injection 1 records · Latest accepted 2025/01/27

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500541Generic2025/01/27Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCDE ↗
Diphenhydramine Hydrochloride Injection 2 records · Latest accepted 2024/12/25

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2404513Generic2024/12/25Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2404512Generic2024/12/25Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanizedCDE ↗
甘油磷酸钠注射液 · No verified English name 1 records · Latest accepted 2024/09/25

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2403219Generic2024/09/25Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCDE ↗
维生素B6注射液 · No verified English name 1 records · Latest accepted 2024/08/01

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402443Generic2024/08/01Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCDE ↗
Diprophylline Injection 1 records · Latest accepted 2024/07/18

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402216Generic2024/07/18Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanizedCDE ↗
Bumetanide Injection 2 records · Latest accepted 2024/07/18

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402232Generic2024/07/18Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanizedCDE ↗
CYHS2402231Generic2024/07/18Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanizedCDE ↗
Propranolol Hydrochloride Injection 1 records · Latest accepted 2024/07/18

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402217Generic2024/07/18Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCDE ↗
Diquafosol Sodium Eye Drops 1 records · Latest accepted 2024/04/01

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400985Generic2024/04/01Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., LtdCDE ↗
Potassium Phosphates Injection 1 records · Latest accepted 2024/03/21

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400885Generic2024/03/21Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanizedCDE ↗
Cimetidine Injection 1 records · Latest accepted 2024/03/15

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400845Generic2024/03/15Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanizedCDE ↗
Potassium Chloride Oral Solution 1 records · Latest accepted 2024/01/13

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400197Generic2024/01/13Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCDE ↗
Potassium Chloride Granules 1 records · Latest accepted 2023/12/15

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2303479Generic2023/12/15Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCDE ↗
草酸艾司西酞普兰口服溶液 · No verified English name 1 records · Latest accepted 2023/11/03

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302987Generic2023/11/03Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCDE ↗
Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution 1 records · Latest accepted 2023/08/31

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302324Generic2023/08/31Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCDE ↗
Pentoxifylline Injection 1 records · Latest accepted 2022/10/11

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201692Generic2022/10/11Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanizedCDE ↗
Urapidil Hydrochloride Injection 1 records · Latest accepted 2022/09/22

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201587Generic2022/09/22Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanizedCDE ↗
Roxatidine Acetate Hydrochloride For Injection 1 records · Latest accepted 2022/04/12

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200564Generic2022/04/12Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Jin Si Li Pharma Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

2 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 applicationNo longer listed under review: 1 application

  1. 2026/11/10No longer listed under review

    Sodium Thiosulfate Injection

    CYHS2500904

    Fact date: 2026/11/10 · Site observation date: 2026/11/10

    Accepted: 2025/03/04

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  2. 2026/11/10Accepted

    Scopolamine Butylbromide Injection

    CYHB2602035

    Fact date: 2026/11/10 · Site observation date: 2026/11/11

    View source ↗

Under review

5 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
Scopolamine Butylbromide Injection CYHB2602035Supplement2026/11/10Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanizedCDE ↗
Sulindac Tablets CYHS2503125Generic2025/08/26Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanizedCDE ↗
Erythromycin Lactobionate for Injection CYHS2502490Generic2025/07/12Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCDE ↗
Erythromycin Lactobionate for Injection CYHS2502489Generic2025/07/12Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCDE ↗
Doxycycline Hyclate for Injection CYHS2501777Generic2025/05/16Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanizedCDE ↗

Catalogue holder records

18 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
Progesterone Soft CapsulesSuzhou Lang Ke Bio Technology Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202651182026/07/08Generic approved under the new chemical-drug registration classificationCDE ↗
Polidocanol InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedJiangsu Hua Yang Pharmaceutical Co., Ltd. romanized国药准字H202648252026/06/17Generic approved under the new chemical-drug registration classificationCDE ↗
Polidocanol InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedJiangsu Hua Yang Pharmaceutical Co., Ltd. romanized国药准字H202648262026/06/17Generic approved under the new chemical-drug registration classificationCDE ↗
Polidocanol InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedJiangsu Hua Yang Pharmaceutical Co., Ltd. romanized国药准字H202648242026/06/17Generic approved under the new chemical-drug registration classificationCDE ↗
甘油磷酸钠注射液 · No verified English nameSuzhou Lang Ke Bio Technology Co., Ltd. romanizedJiangsu Hua Yang Pharmaceutical Co., Ltd. romanized国药准字H202638982026/04/07Generic approved under the new chemical-drug registration classificationCDE ↗
Scopolamine Butylbromide InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedJiangsu Hua Yang Pharmaceutical Co., Ltd. romanized国药准字H202636422026/03/17Generic approved under the new chemical-drug registration classificationCDE ↗
Bumetanide InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedYang Zhou Zhong Bao Pharma Co., Ltd. romanized国药准字H202631822026/01/20Generic approved under the new chemical-drug registration classificationCDE ↗
Potassium Phosphates InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedYang Zhou Zhong Bao Pharma Co., Ltd. romanized国药准字H202561622025/12/03Generic approved under the new chemical-drug registration classificationCDE ↗
Diprophylline InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedYang Zhou Zhong Bao Pharma Co., Ltd. romanized国药准字H202560582025/11/25Generic approved under the new chemical-drug registration classificationCDE ↗
Cimetidine InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedYang Zhou Zhong Bao Pharma Co., Ltd. romanized国药准字H202558222025/11/04Generic approved under the new chemical-drug registration classificationCDE ↗
Potassium Chloride GranulesSuzhou Lang Ke Bio Technology Co., Ltd. romanizedNanjing Hai Na Pharmaceutical Co., Ltd. romanized国药准字H202557282025/10/21Generic approved under the new chemical-drug registration classificationCDE ↗
Pentoxifylline InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedHebei Kai Wei Pharmaceutical Co., Ltd. romanized国药准字H202438812024/06/04Generic approved under the new chemical-drug registration classificationCDE ↗
Urapidil Hydrochloride InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedHebei Kai Wei Pharmaceutical Co., Ltd. romanized国药准字H202434182024/03/29Generic approved under the new chemical-drug registration classificationCDE ↗
Roxatidine Acetate Hydrochloride For InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedJiangsu Jin Si Li Pharma Co., Ltd. romanized国药准字H202341482023/09/12Generic approved under the new chemical-drug registration classificationCDE ↗
Paricalcitol InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedHebei Kai Wei Pharmaceutical Co., Ltd. romanized国药准字H202233042022/05/10Generic approved under the new chemical-drug registration classificationCDE ↗
Cisatracurium Besylate InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedSichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized国药准字H202139842021/12/31Generic approved under the new chemical-drug registration classificationCDE ↗
Calcitriol InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedHebei Kai Wei Pharmaceutical Co., Ltd. romanized国药准字H202640762026/04/21Generic approved under the new chemical-drug registration classificationCDE ↗
Propranolol Hydrochloride InjectionSuzhou Lang Ke Bio Technology Co., Ltd. romanizedJiangsu Hua Yang Pharmaceutical Co., Ltd. romanized国药准字H202635202026/03/10Generic 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.