Gland Pharma Limited
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 8c04318ff6
These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/11 06:42.
Drug filings
7 acceptance records as first applicant, grouped into 7 source drug names. Source data as of 2026/11/11 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.
Polymyxin B sulfate for Injection 1 records · Latest accepted 2026/04/29
Import (made outside China) · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JTH2600083 | Import (made outside China) | 2026/04/29 | Gland Pharma Limited; Hikma Pharmaceuticals USA Inc.; Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized | CDE ↗ |
Carboprost Tromethamine Injection 1 records · Latest accepted 2025/09/10
Not stated by source · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JTH2500139 | Not stated by source | 2025/09/10 | Gland Pharma Limited; Pfizer Inc; Hui Rui Investment Co., Ltd. romanized | CDE ↗ |
Cetrorelix Acetate for Injection 1 records · Latest accepted 2023/12/05
Import · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHS2300134 | Import | 2023/12/05 | Gland Pharma Limited; Shenyang Hongqi Pharmaceutical Co. Ltd. | CDE ↗ |
Ertapenem For Injection 1 records · Latest accepted 2023/07/05
Import · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHS2300082 | Import | 2023/07/05 | Gland Pharma Limited; Suzhou Erye Pharmaceutical Co. Ltd. | CDE ↗ |
Caspofungin Acetate for Injection 1 records · Latest accepted 2023/03/07
Import · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHS2300034 | Import | 2023/03/07 | Gland Pharma Limited; Suzhou Erye Pharmaceutical Co. Ltd. | CDE ↗ |
Ziprasidone Mesylate for Injection 1 records · Latest accepted 2021/11/05
Import · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHS2101053 | Import | 2021/11/05 | Gland Pharma Limited; Hunan Dongting Pharmaceutical Co. Ltd. | CDE ↗ |
Zoledronic Acid Concentrated Solution for Injection 1 records · Latest accepted 2021/03/26
Import · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| JYHS2100048 | Import | 2021/03/26 | Gland Pharma Limited | CDE ↗ |
Changes in the last 90 days
0 events from 2026/08/14 to 2026/11/11. CDE data as of 2026/11/11 06:42; NMPA data as of 2026/11/10 18:31.
This source was last successfully updated at 2026/11/10 18:31; 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
Under review
0 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/11 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. | |||||
Catalogue holder records
5 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/11 06:38. Manufacturer-only records are excluded.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Caspofungin Acetate for Injection | Gland Pharma Limited | Gland Pharma Limited | 国药准字HJ20250071 | 2025/06/17 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ziprasidone Mesylate for Injection | Gland Pharma Limited | Gland Pharma Limited | 国药准字HJ20240073 | 2024/07/30 | Not stated by source | CDE ↗ |
| Zoledronic Acid Concentrated Solution for Injection | Gland Pharma Limited | Gland Pharma Limited | 国药准字HJ20240011 | 2024/04/24 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Zoledronic Acid Injection | Gland Pharma Limited | Gland Pharma Limited | 国药准字HJ20230140 | 2023/12/05 | Not stated by source | CDE ↗ |
| Dexrazoxane for Injection | Gland Pharma Limited | Gland Pharma Limited | 国药准字HJ20233122 | 2023/02/07 | 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
2 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/11 06:40.
| Name | Company / applicant | Registration number | Status | Source update date | View source |
|---|---|---|---|---|---|
| No verified English name | Gland Pharma Limited | Y20190000179 | A | 2024/11/02 | CDE ↗ |
| No verified English name | Gland Pharma Limited | Y20180001635 | I | 2019/02/22 | CDE ↗ |
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
2 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 2026/11/11 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Polymyxin B sulfate for Injection | JYHS2101056 | Import | 2021/11/18 | Xellia Pharmaceuticals ApS; Gland Pharma Limited; Xellia Pharmaceuticals Shanghai Co. Ltd. | CDE ↗ |
| Glatiramer Acetate Injection | JYHS2100014 | Import | 2021/01/28 | Mylan Pharmaceuticals Inc.; Gland Pharma Limited | CDE ↗ |
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/11 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/11 06:38
- Full API register
- Last successful update: 2026/11/11 06:40
- NMPA drug delivery notices
- Last successful update: 2026/11/10 18:31 · Current coverage may be incomplete
First index-page publication dates: — to —; 0 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.
Drug names use verified official English names only. Missing names are shown as No verified English name, linking to a Chinese page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized. Original statutory reference numbers are the sole visible Chinese exception.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Chinese free text is not displayed; use the source links or source-name columns in CSV exports.