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
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
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2602035 | Supplement | 2026/11/10 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2402331 | Generic | 2024/07/24 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Doxycycline Hyclate Tablets 2 records · Latest accepted 2026/01/23
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600143 | Supplement | 2026/01/23 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2600142 | Supplement | 2026/01/23 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Calcitriol Injection 1 records · Latest accepted 2025/12/19
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2502542 | Supplement | 2025/12/19 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Sulindac Tablets 1 records · Latest accepted 2025/08/26
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2503125 | Generic | 2025/08/26 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized | CDE ↗ |
Erythromycin Lactobionate for Injection 2 records · Latest accepted 2025/07/12
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502490 | Generic | 2025/07/12 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2502489 | Generic | 2025/07/12 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized | CDE ↗ |
Doxycycline Hyclate for Injection 1 records · Latest accepted 2025/05/16
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501777 | Generic | 2025/05/16 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized | CDE ↗ |
Polidocanol Injection 3 records · Latest accepted 2025/03/29
Generic · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501225 | Generic | 2025/03/29 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2501224 | Generic | 2025/03/29 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2501223 | Generic | 2025/03/29 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Progesterone Soft Capsules 1 records · Latest accepted 2025/03/19
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501103 | Generic | 2025/03/19 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Sodium Thiosulfate Injection 2 records · Latest accepted 2025/03/04
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2500905 | Generic | 2025/03/04 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized | CDE ↗ |
| CYHS2500904 | Generic | 2025/03/04 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized | CDE ↗ |
Fluorescein Sodium Injection 1 records · Latest accepted 2025/01/27
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2500541 | Generic | 2025/01/27 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Diphenhydramine Hydrochloride Injection 2 records · Latest accepted 2024/12/25
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2404513 | Generic | 2024/12/25 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2404512 | Generic | 2024/12/25 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized | CDE ↗ |
甘油磷酸钠注射液 · No verified English name 1 records · Latest accepted 2024/09/25
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2403219 | Generic | 2024/09/25 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
维生素B6注射液 · No verified English name 1 records · Latest accepted 2024/08/01
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402443 | Generic | 2024/08/01 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Diprophylline Injection 1 records · Latest accepted 2024/07/18
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402216 | Generic | 2024/07/18 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | CDE ↗ |
Bumetanide Injection 2 records · Latest accepted 2024/07/18
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402232 | Generic | 2024/07/18 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2402231 | Generic | 2024/07/18 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | CDE ↗ |
Propranolol Hydrochloride Injection 1 records · Latest accepted 2024/07/18
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402217 | Generic | 2024/07/18 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Diquafosol Sodium Eye Drops 1 records · Latest accepted 2024/04/01
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400985 | Generic | 2024/04/01 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Hangzhou Minsheng Pharmaceutical Co., Ltd | CDE ↗ |
Potassium Phosphates Injection 1 records · Latest accepted 2024/03/21
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400885 | Generic | 2024/03/21 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | CDE ↗ |
Cimetidine Injection 1 records · Latest accepted 2024/03/15
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400845 | Generic | 2024/03/15 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | CDE ↗ |
Potassium Chloride Oral Solution 1 records · Latest accepted 2024/01/13
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400197 | Generic | 2024/01/13 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Potassium Chloride Granules 1 records · Latest accepted 2023/12/15
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2303479 | Generic | 2023/12/15 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
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
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2302987 | Generic | 2023/11/03 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution 1 records · Latest accepted 2023/08/31
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2302324 | Generic | 2023/08/31 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Pentoxifylline Injection 1 records · Latest accepted 2022/10/11
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2201692 | Generic | 2022/10/11 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Urapidil Hydrochloride Injection 1 records · Latest accepted 2022/09/22
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2201587 | Generic | 2022/09/22 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Roxatidine Acetate Hydrochloride For Injection 1 records · Latest accepted 2022/04/12
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200564 | Generic | 2022/04/12 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Jin Si Li Pharma Co., Ltd. romanized | CDE ↗ |
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
- 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 ↗ - 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.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Scopolamine Butylbromide Injection | CYHB2602035 | Supplement | 2026/11/10 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Sulindac Tablets | CYHS2503125 | Generic | 2025/08/26 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized | CDE ↗ |
| Erythromycin Lactobionate for Injection | CYHS2502490 | Generic | 2025/07/12 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized | CDE ↗ |
| Erythromycin Lactobionate for Injection | CYHS2502489 | Generic | 2025/07/12 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized | CDE ↗ |
| Doxycycline Hyclate for Injection | CYHS2501777 | Generic | 2025/05/16 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized | CDE ↗ |
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.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Progesterone Soft Capsules | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20265118 | 2026/07/08 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Polidocanol Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20264825 | 2026/06/17 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Polidocanol Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20264826 | 2026/06/17 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Polidocanol Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20264824 | 2026/06/17 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| 甘油磷酸钠注射液 · No verified English name | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20263898 | 2026/04/07 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Scopolamine Butylbromide Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20263642 | 2026/03/17 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Bumetanide Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H20263182 | 2026/01/20 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Potassium Phosphates Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H20256162 | 2025/12/03 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Diprophylline Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H20256058 | 2025/11/25 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Cimetidine Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | 国药准字H20255822 | 2025/11/04 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Potassium Chloride Granules | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20255728 | 2025/10/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Pentoxifylline Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Hebei Kai Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20243881 | 2024/06/04 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Urapidil Hydrochloride Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Hebei Kai Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20243418 | 2024/03/29 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Roxatidine Acetate Hydrochloride For Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Jiangsu Jin Si Li Pharma Co., Ltd. romanized | 国药准字H20234148 | 2023/09/12 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Paricalcitol Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Hebei Kai Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20223304 | 2022/05/10 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Cisatracurium Besylate Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20213984 | 2021/12/31 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Calcitriol Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Hebei Kai Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20264076 | 2026/04/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Propranolol Hydrochloride Injection | Suzhou Lang Ke Bio Technology Co., Ltd. romanized | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20263520 | 2026/03/10 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
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.
| Name | Company / applicant | Registration number | Status | Source update date | View 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.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View 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.