Henan Ke Lun Pharma 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 5a345946b7
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 11 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.
注射用头孢美唑钠/氯化钠注射液 · No verified English name 2 records · Latest accepted 2025/06/27
Supplement · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2501269 | Supplement | 2025/06/27 | Henan Ke Lun Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2401331 | Supplement | 2024/08/27 | Henan Ke Lun Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Penehyclidine Hydrochloride Injection 1 records · Latest accepted 2025/05/30
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2501106 | Supplement | 2025/05/30 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
Progesterone Injection 2 records · Latest accepted 2025/04/24
Generic · 1Supplement · 1
Diclofenac Diethylamine Emulgel 1 records · Latest accepted 2025/04/23
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501522 | Generic | 2025/04/23 | Henan Ke Lun Pharma Co., Ltd. romanized; Jiangsu Ziyond Pharmaceutical Co., Ltd. | CDE ↗ |
Lidocaine and Prilocaine Cream 1 records · Latest accepted 2024/11/26
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2401985 | Supplement | 2024/11/26 | Henan Ke Lun Pharma Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized | CDE ↗ |
Mivacurium Chloride Injection 2 records · Latest accepted 2024/11/05
Generic · 2
Nicardipine Hydrochloride Injection 1 records · Latest accepted 2024/01/23
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400305 | Generic | 2024/01/23 | Henan Ke Lun Pharma Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
氯化钠注射液 · No verified English name 5 records · Latest accepted 2023/07/11
Supplement · 5
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2301535 | Supplement | 2023/07/11 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2301177 | Supplement | 2023/05/23 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2101740 | Supplement | 2021/08/31 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2101739 | Supplement | 2021/08/31 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2101738 | Supplement | 2021/08/31 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
葡萄糖注射液 · No verified English name 8 records · Latest accepted 2023/07/11
Supplement · 8
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2301531 | Supplement | 2023/07/11 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2301178 | Supplement | 2023/05/23 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2100246 | Supplement | 2021/02/10 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2100245 | Supplement | 2021/02/10 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2100244 | Supplement | 2021/02/10 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2100235 | Supplement | 2021/02/09 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2100234 | Supplement | 2021/02/09 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2100233 | Supplement | 2021/02/09 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
Piracetam Injection 1 records · Latest accepted 2022/09/01
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2201429 | Generic | 2022/09/01 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
葡萄糖氯化钠注射液 · No verified English name 3 records · Latest accepted 2021/02/10
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2100243 | Supplement | 2021/02/10 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2100242 | Supplement | 2021/02/10 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2100241 | Supplement | 2021/02/09 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
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.
No longer listed under review: 1 application
- 2026/10/28No longer listed under review
Diclofenac Diethylamine Emulgel
CYHS2501522
Fact date: 2026/10/28 · Site observation date: 2026/10/28
Accepted: 2025/04/23
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗
Under review
1 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 |
|---|---|---|---|---|---|
| Progesterone Injection | CYHS2501540 | Generic | 2025/04/24 | Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
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.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Mivacurium Chloride Injection | Henan Ke Lun Pharma Co., Ltd. romanized | Henan Ke Lun Pharma Co., Ltd. romanized | 国药准字H20265462 | 2026/08/04 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Mivacurium Chloride Injection | Henan Ke Lun Pharma Co., Ltd. romanized | Henan Ke Lun Pharma Co., Ltd. romanized | 国药准字H20265463 | 2026/08/04 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Piracetam Injection | Henan Ke Lun Pharma Co., Ltd. romanized | Henan Ke Lun Pharma Co., Ltd. romanized | 国药准字H20243105 | 2024/01/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Multiple Electrolytes Injection(Ⅱ) | Henan Ke Lun Pharma Co., Ltd. romanized | Henan Ke Lun Pharma Co., Ltd. romanized | 国药准字H20233452 | 2023/04/11 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Multiple Electrolytes Injection(Ⅱ) | Henan Ke Lun Pharma Co., Ltd. romanized | Henan Ke Lun Pharma Co., Ltd. romanized | 国药准字H20233430 | 2023/04/11 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Sodium Acetate Ringer's Injection | Henan Ke Lun Pharma Co., Ltd. romanized | Henan Ke Lun Pharma Co., Ltd. romanized | 国药准字H20233013 | 2023/01/09 | 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
1 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 |
|---|---|---|---|---|---|
| 尼莫地平 · No verified English name | Henan Ke Lun Pharma Co., Ltd. romanized | Y20190004746 | A | 2024/11/01 | 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
36 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 |
|---|---|---|---|---|---|
| 氯化钠注射液 · No verified English name | CYHB2602051 | Supplement | 2026/11/11 | Sichuan Kelun Pharmaceutical Co., Ltd.; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 葡萄糖注射液 · No verified English name | CYHB2601001 | Supplement | 2026/05/27 | Sichuan Kelun Pharmaceutical Co., Ltd.; Guizhou Ke Lun Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| Dexamethasone Sodium Phosphate Injection | CYHB2600588 | Supplement | 2026/03/25 | Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| Dexamethasone Sodium Phosphate Injection | CYHB2600587 | Supplement | 2026/03/25 | Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 曲克芦丁注射液 · No verified English name | CYHB2600512 | Supplement | 2026/03/13 | CISEN PHARMACEUTICAL CO., LTD.; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 复方黄体酮注射液 · No verified English name | CYHB2502388 | Supplement | 2025/11/22 | Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 替硝唑氯化钠注射液 · No verified English name | CYHB2502338 | Supplement | 2025/11/12 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 丙酸睾酮注射液 · No verified English name | CYHB2502266 | Supplement | 2025/11/04 | Henan He Zhi Pharmaceuticals Technology Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 盐酸左氧氟沙星氯化钠注射液 · No verified English name | CYHB2501829 | Supplement | 2025/09/13 | Sichuan Kelun Pharmaceutical Co., Ltd.; Guangdong Ke Hong Pharma Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized; Jiangxi Ke Lun Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 氯化钠注射液 · No verified English name | CYHB2501534 | Supplement | 2025/08/02 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 氯化钠注射液 · No verified English name | CYHB2501533 | Supplement | 2025/08/02 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 氯化钠注射液 · No verified English name | CYHB2501532 | Supplement | 2025/08/02 | Sichuan Kelun Pharmaceutical Co., Ltd.; Guizhou Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 葡萄糖注射液 · No verified English name | CYHB2501528 | Supplement | 2025/08/02 | Sichuan Kelun Pharmaceutical Co., Ltd.; Guizhou Ke Lun Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 葡萄糖注射液 · No verified English name | CYHB2501527 | Supplement | 2025/08/02 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 葡萄糖注射液 · No verified English name | CYHB2501525 | Supplement | 2025/08/02 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Guizhou Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| Metronidazole and Sodium Chloride Injection | CYHB2501505 | Supplement | 2025/07/30 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 氯化钠注射液 · No verified English name | CYHB2500725 | Supplement | 2025/04/11 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized | CDE ↗ |
| 氯化钠注射液 · No verified English name | CYHB2500724 | Supplement | 2025/04/11 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized | CDE ↗ |
| 氯化钠注射液 · No verified English name | CYHB2500723 | Supplement | 2025/04/11 | Sichuan Kelun Pharmaceutical Co., Ltd.; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 氯化钠注射液 · No verified English name | CYHB2500722 | Supplement | 2025/04/11 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized | CDE ↗ |
| 氯化钠注射液 · No verified English name | CYHB2500721 | Supplement | 2025/04/11 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized | CDE ↗ |
| 葡萄糖注射液 · No verified English name | CYHB2500585 | Supplement | 2025/03/21 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized | CDE ↗ |
| 葡萄糖注射液 · No verified English name | CYHB2500584 | Supplement | 2025/03/21 | Sichuan Kelun Pharmaceutical Co., Ltd.; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized; Heilongjiang Bo Yu Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 葡萄糖注射液 · No verified English name | CYHB2500583 | Supplement | 2025/03/21 | Sichuan Kelun Pharmaceutical Co., Ltd.; Shandong Ke Lun Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 葡萄糖注射液 · No verified English name | CYHB2500582 | Supplement | 2025/03/21 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized | CDE ↗ |
| 葡萄糖注射液 · No verified English name | CYHB2500581 | Supplement | 2025/03/21 | Sichuan Kelun Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized; Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized; Guangdong Ke Hong Pharma Co., Ltd. romanized | CDE ↗ |
| 氯化钠注射液 · No verified English name | CYHB2500021 | Supplement | 2025/01/04 | Sichuan Kelun Pharmaceutical Co., Ltd.; Liaoning Min Kang Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized; Shandong Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| Betamethasone Sodium Phosphate Injection | CYHS2404040 | Generic | 2024/11/23 | Anhui Mei Lai Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| Progesterone Injection | CYHS2403721 | Generic | 2024/11/01 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| Dexamethasone Sodium Phosphate Injection | CYHS2402133 | Generic | 2024/07/12 | Anhui Mei Lai Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 维生素B6注射液 · No verified English name | CYHS2401646 | Generic | 2024/06/01 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| 水溶性黄体酮注射液 · No verified English name | CYHS2400541 | Generic | 2024/02/07 | Shijiazhuang No.4 Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| Penehyclidine Hydrochloride Injection | CYHS2400366 | Generic | 2024/01/27 | Guangxi Ke Lun Pharmaceutical Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| Potassium Chloride Injection | CYHS2302276 | Generic | 2023/08/26 | Guangdong Ke Hong Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| Potassium Chloride Injection | CYHS2302275 | Generic | 2023/08/26 | Guangdong Ke Hong Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
| Sodium Acetate Ringer's Injection | CYHB2301599 | Supplement | 2023/07/14 | Fujian Pin Teng Pharma Co., Ltd. romanized; Henan Ke Lun Pharma Co., Ltd. romanized | CDE ↗ |
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.