Monthly
US$200
Billed every month
地氯雷他定口服溶液
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 applications
Current coverage may be incomplete
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders0View records ↓
Under-review filings26View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers41View records ↓
API companies with A status21View records ↓
Chemical-drug catalogue
Loaded records: 0 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 41 distinct approval numbers and 35 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京四环科宝制药股份有限公司 | 国药准字H20263402 | 2.5ml:1.25mg | Category B (乙) | XR06AXD078X001010100151 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001010100299 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20233933 | 100ml:50mg | Category B (乙) | XR06AXD078X001010101503 | NHSA |
| 扬子江药业集团有限公司 | 国药准字H20223844 | 150ml:75mg | Category B (乙) | XR06AXD078X001010101747 | NHSA |
| 四川大冢制药有限公司 | 国药准字H20266083 | 100ml:50mg | Category B (乙) | XR06AXD078X001010102132 | NHSA |
| 亚宝药业四川制药有限公司 | 国药准字H20244538 | 60ml:30mg | Category B (乙) | XR06AXD078X001010102281 | NHSA |
| 石家庄凯达生物工程有限公司 | 国药准字H20255548 | 100ml:50mg | Category B (乙) | XR06AXD078X001010102680 | NHSA |
| 浙江众延医药科技有限公司 | 国药准字H20223977 | 100ml:50mg | Category B (乙) | XR06AXD078X001010102753 | NHSA |
| 山东达因海洋生物制药股份有限公司 | 国药准字H20213379 | 100ml:50mg | Category B (乙) | XR06AXD078X001010104077 | NHSA |
| 贵州阜康仁制药有限公司 | 国药准字H20233919 | 100ml:50mg | Category B (乙) | XR06AXD078X001010104193 | NHSA |
| 国药集团致君(深圳)制药有限公司 | 国药准字H20233918 | 100ml:50mg | Category B (乙) | XR06AXD078X001010104360 | NHSA |
| 西洲医药科技(浙江)有限公司 | 国药准字H20223551 | 100ml:50mg | Category B (乙) | XR06AXD078X001010104610 | NHSA |
| 恒昌(广州)新药研究有限公司 | 国药准字H20234085 | 120ml:60mg | Category B (乙) | XR06AXD078X001010104670 | NHSA |
| 湖南嘉恒制药有限公司 | 国药准字H20254559 | 100ml:50mg | Category B (乙) | XR06AXD078X001010104891 | NHSA |
| 广西维威制药有限公司 | 国药准字H20233983 | 30ml:15mg | Category B (乙) | XR06AXD078X001010105237 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20243860 | 10ml:5mg | Category B (乙) | XR06AXD078X001010105356 | NHSA |
| 海口市制药厂有限公司 | 国药准字H20223980 | 120ml:60mg | Category B (乙) | XR06AXD078X001010105815 | NHSA |
| 海南斯达制药有限公司 | 国药准字H20253004 | 50ml:25mg | Category B (乙) | XR06AXD078X001010105816 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20223776 | 100ml:50mg | Category B (乙) | XR06AXD078X001010109554 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20213651 | 50ml:25mg | Category B (乙) | XR06AXD078X001010110237 | NHSA |
| 漳州片仔癀药业股份有限公司 | 国药准字H20213056 | 30ml:15mg | Category B (乙) | XR06AXD078X001010110323 | NHSA |
| 哈尔滨圣泰生物制药有限公司 | 国药准字H20223971 | 10ml:5mg | Category B (乙) | XR06AXD078X001010181654 | NHSA |
| 浙江普利药业有限公司 | 国药准字H20253993 | 60ml:30mg | Category B (乙) | XR06AXD078X001010182922 | NHSA |
| 江苏悦兴药业有限公司 | 国药准字H20255079 | 30ml:15mg | Category B (乙) | XR06AXD078X001010183530 | NHSA |
| 汕头经济特区明治医药有限公司 | 国药准字H20244193 | 100ml:50mg | Category B (乙) | XR06AXD078X001010183539 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253986 | 2.5ml:1.25mg | Category B (乙) | XR06AXD078X001010183595 | NHSA |
| 辽宁儿童制药有限公司 | 国药准字H20243788 | 60ml:30mg | Category B (乙) | XR06AXD078X001010183667 | NHSA |
| 深圳市贝美药业有限公司 | 国药准字H20249820 | 120ml:60mg | Category B (乙) | XR06AXD078X001010183798 | NHSA |
| 江苏开元药业有限公司 | 国药准字H20255941 | 100ml:50mg | Category B (乙) | XR06AXD078X001010183955 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20254525 | 60ml:30mg | Category B (乙) | XR06AXD078X001010184221 | NHSA |
| 山东简道制药有限公司 | 国药准字H20254729 | 100ml:50mg | Category B (乙) | XR06AXD078X001010184386 | NHSA |
| 江苏欧歌制药有限公司 | 国药准字H20254995 | 100ml:50mg | Category B (乙) | XR06AXD078X001010184450 | NHSA |
| 湖北美思创药业有限公司 | 国药准字H20254730 | 100ml:50mg | Category B (乙) | XR06AXD078X001010184577 | NHSA |
| 广东大鹏药业有限公司 | 国药准字H20253462 | 100ml:50mg | Category B (乙) | XR06AXD078X001010184654 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263402 | 2.5ml:1.25mg | Category B (乙) | XR06AXD078X001010200151 | NHSA |
| 江苏万高药业股份有限公司 | 国药准字H20254327 | 100ml:50mg | Category B (乙) | XR06AXD078X001010201503 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20243860 | 10ml:5mg | Category B (乙) | XR06AXD078X001010205356 | NHSA |
| 哈尔滨圣泰生物制药有限公司 | 国药准字H20223971 | 10ml:5mg | Category B (乙) | XR06AXD078X001010281654 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253986 | 2.5ml:1.25mg | Category B (乙) | XR06AXD078X001010283595 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263402 | 2.5ml:1.25mg | Category B (乙) | XR06AXD078X001010300151 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20243860 | 10ml:5mg | Category B (乙) | XR06AXD078X001010305356 | NHSA |
| 哈尔滨圣泰生物制药有限公司 | 国药准字H20223971 | 10ml:5mg | Category B (乙) | XR06AXD078X001010381654 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253986 | 2.5ml:1.25mg | Category B (乙) | XR06AXD078X001010383595 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263402 | 2.5ml:1.25mg | Category B (乙) | XR06AXD078X001010400151 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20243860 | 10ml:5mg | Category B (乙) | XR06AXD078X001010405356 | NHSA |
| 哈尔滨圣泰生物制药有限公司 | 国药准字H20223971 | 10ml:5mg | Category B (乙) | XR06AXD078X001010481654 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253986 | 2.5ml:1.25mg | Category B (乙) | XR06AXD078X001010483595 | NHSA |
| 哈尔滨圣泰生物制药有限公司 | 国药准字H20223971 | 10ml:5mg | Category B (乙) | XR06AXD078X001010581654 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263400 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020100151 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001020100299 | NHSA |
| 石家庄凯达生物工程有限公司 | 国药准字H20255547 | 60ml:30mg | Category B (乙) | XR06AXD078X001020102680 | NHSA |
| 浙江众延医药科技有限公司 | 国药准字H20223977 | 100ml:50mg | Category B (乙) | XR06AXD078X001020102753 | NHSA |
| 山东达因海洋生物制药股份有限公司 | 国药准字H20213379 | 100ml:50mg | Category B (乙) | XR06AXD078X001020104077 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20258038 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020105356 | NHSA |
| 海口市制药厂有限公司 | 国药准字H20223980 | 120ml:60mg | Category B (乙) | XR06AXD078X001020105815 | NHSA |
| 福安药业集团湖北人民制药有限公司 | 国药准字H20223776 | 100ml:50mg | Category B (乙) | XR06AXD078X001020109554 | NHSA |
| 哈尔滨圣泰生物制药有限公司 | 国药准字H20223971 | 10ml:5mg | Category B (乙) | XR06AXD078X001020181654 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253987 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020183595 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263400 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020200151 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001020200299 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20258038 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020205356 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253987 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020283595 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263400 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020300151 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20258038 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020305356 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253987 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020383595 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263400 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020400151 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20258038 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020405356 | NHSA |
| 安徽四环科宝制药有限公司 | 国药准字H20253987 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001020483595 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263401 | 10ml:5mg | Category B (乙) | XR06AXD078X001030100151 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001030100299 | NHSA |
| 浙江众延医药科技有限公司 | 国药准字H20223977 | 100ml:50mg | Category B (乙) | XR06AXD078X001030102753 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20269176 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001030110237 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263401 | 10ml:5mg | Category B (乙) | XR06AXD078X001030200151 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001030200299 | NHSA |
| 合肥恩瑞特药业有限公司 | 国药准字H20269176 | 5ml:2.5mg | Category B (乙) | XR06AXD078X001030210237 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263401 | 10ml:5mg | Category B (乙) | XR06AXD078X001030300151 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001030300299 | NHSA |
| 北京四环科宝制药股份有限公司 | 国药准字H20263401 | 10ml:5mg | Category B (乙) | XR06AXD078X001030400151 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001030400299 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001030500299 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001030600299 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001030700299 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001030800299 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001030900299 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001031000299 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001031100299 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001031200299 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001031300299 | NHSA |
| 广东九明制药有限公司 | 国药准字H20213960 | 60ml:30mg | Category B (乙) | XR06AXD078X001031400299 | NHSA |
| 浙江众延医药科技有限公司 | 国药准字H20223977 | 100ml:50mg | Category B (乙) | XR06AXD078X001040102753 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 26 filings and 17 distinct first applicants.
Generic 20 · Supplement 6
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏天士力帝益药业有限公司 | CYHS2501850 | Generic | 2025/05/22 | Not stated by source | CDE |
| 江苏天士力帝益药业有限公司 | CYHS2501849 | Generic | 2025/05/22 | Not stated by source | CDE |
| 江苏贝佳制药有限公司 | CYHS2600030 | Generic | 2026/01/05 | Not stated by source | CDE |
| 江苏贝佳制药有限公司 | CYHS2600029 | Generic | 2026/01/05 | Not stated by source | CDE |
| 恒昌（广州）新药研究有限公司;浙江康恩贝制药股份有限公司 | CYHB2601919 | Supplement | 2026/10/21 | Not stated by source | CDE |
| 恒昌（广州）新药研究有限公司;浙江康恩贝制药股份有限公司 | CYHB2601918 | Supplement | 2026/10/21 | Not stated by source | CDE |
| 重庆大健能制药有限公司 | CYHS2601832 | Generic | 2026/07/30 | Not stated by source | CDE |
| 重庆大健能制药有限公司 | CYHS2601831 | Generic | 2026/07/30 | Not stated by source | CDE |
| 安徽四环科宝制药有限公司 | CYHB2601435 | Supplement | 2026/07/27 | Not stated by source | CDE |
| 湖北美思创药业有限公司 | CYHB2601372 | Supplement | 2026/07/20 | Not stated by source | CDE |
| 湖北美思创药业有限公司 | CYHB2601371 | Supplement | 2026/07/20 | Not stated by source | CDE |
| 四川合纵泽辉医药科技有限公司;江西施美药业股份有限公司 | CYHB2601120 | Supplement | 2026/06/12 | Not stated by source | CDE |
| 浙江迪耳药业有限公司 | CYHS2601108 | Generic | 2026/05/13 | Not stated by source | CDE |
| 浙江迪耳药业有限公司 | CYHS2601107 | Generic | 2026/05/13 | Not stated by source | CDE |
| 贵州黔药集团制药有限公司;湖南九典制药股份有限公司 | CYHS2600640 | Generic | 2026/03/11 | Not stated by source | CDE |
| 广东南国药业有限公司 | CYHS2504035 | Generic | 2025/11/22 | Not stated by source | CDE |
| 河北山姆士药业有限公司 | CYHS2503683 | Generic | 2025/10/15 | Not stated by source | CDE |
| 四川森科制药有限公司 | CYHS2503533 | Generic | 2025/09/28 | Not stated by source | CDE |
| 广州聚力医药开发有限公司;广东众生药业股份有限公司 | CYHS2503469 | Generic | 2025/09/19 | Not stated by source | CDE |
| 千海始德堂（鹤壁）制药有限公司 | CYHS2503163 | Generic | 2025/08/29 | Not stated by source | CDE |
| 千海始德堂（鹤壁）制药有限公司 | CYHS2503162 | Generic | 2025/08/29 | Not stated by source | CDE |
| 河南华雒康润药业有限公司 | CYHS2501488 | Generic | 2025/04/19 | Not stated by source | CDE |
| 湖北午时药业股份有限公司 | CYHS2501026 | Generic | 2025/03/12 | Not stated by source | CDE |
| 湖北午时药业股份有限公司 | CYHS2501025 | Generic | 2025/03/12 | Not stated by source | CDE |
| 天津和治药业集团有限公司 | CYHS2501018 | Generic | 2025/03/12 | Not stated by source | CDE |
| 天津和治药业集团有限公司 | CYHS2501017 | Generic | 2025/03/12 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 9 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏贝佳制药有限公司 | CYHS2600030 | Generic | 2026/01/05 | Not stated by source | CDE |
| 江苏贝佳制药有限公司 | CYHS2600029 | Generic | 2026/01/05 | Not stated by source | CDE |
| 吉林华康药业股份有限公司 | CYHS2601855 | Generic | 2026/08/03 | Not stated by source | CDE |
| 吉林华康药业股份有限公司 | CYHS2601854 | Generic | 2026/08/03 | Not stated by source | CDE |
| 重庆大健能制药有限公司 | CYHS2601832 | Generic | 2026/07/30 | Not stated by source | CDE |
| 重庆大健能制药有限公司 | CYHS2601831 | Generic | 2026/07/30 | Not stated by source | CDE |
| 浙江迪耳药业有限公司 | CYHS2601108 | Generic | 2026/05/13 | Not stated by source | CDE |
| 浙江迪耳药业有限公司 | CYHS2601107 | Generic | 2026/05/13 | Not stated by source | CDE |
| 贵州黔药集团制药有限公司;湖南九典制药股份有限公司 | CYHS2600640 | Generic | 2026/03/11 | Not stated by source | CDE |
API registrations
Non-component matches: 21 companies with A status and 3 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 地氯雷他定 | DIVI’S LABORATORIES LIMITED | Y20250000454 | I | Exact ingredient | 2025/08/08 | CDE |
| 地氯雷他定 | Vasudha Pharma Chem Limited | Y20220001192 | A | Exact ingredient | 2026/07/26 | CDE |
| 地氯雷他定 | 浙江赛默制药有限公司 | Y20220000644 | A | Exact ingredient | 2025/06/26 | CDE |
| 地氯雷他定 | Cadila Healthcare Limited | Y20210001016 | I | Exact ingredient | 2022/01/19 | CDE |
| 地氯雷他定 | 沈阳三九药业有限公司 | Y20200001494 | A | Exact ingredient | 2024/06/21 | CDE |
| 地氯雷他定 | 海南普利制药股份有限公司 | Y20190009677 | A | Exact ingredient | — | CDE |
| 地氯雷他定 | 浙江华海药业股份有限公司 | Y20190007518 | A | Exact ingredient | 2024/08/08 | CDE |
| 地氯雷他定 | 太极集团重庆涪陵制药厂有限公司 | Y20190007333 | A | Exact ingredient | — | CDE |
| 地氯雷他定 | 广东九明制药有限公司 | Y20190007236 | A | Exact ingredient | 2024/04/04 | CDE |
| 地氯雷他定 | 成都明日制药有限公司 | Y20190006257 | A | Exact ingredient | 2026/02/28 | CDE |
| 地氯雷他定 | 惠州信立泰药业有限公司 | Y20190006198 | A | Exact ingredient | 2026/01/31 | CDE |
| 地氯雷他定 | 上海新亚药业有限公司 | Y20190005536 | A | Exact ingredient | — | CDE |
| 地氯雷他定 | 深圳市海滨制药有限公司 | Y20190004115 | A | Exact ingredient | 2024/06/21 | CDE |
| 地氯雷他定 | 浙江华润三九众益制药有限公司 | Y20190002166 | A | Exact ingredient | 2024/10/09 | CDE |
| 地氯雷他定 | 常州方圆制药有限公司 | Y20190001909 | A | Exact ingredient | — | CDE |
| 地氯雷他定 | 万特制药（海南）有限公司 | Y20190001403 | A | Exact ingredient | 2024/10/22 | CDE |
| 地氯雷他定 | INKE, S.A. | Y20190000120 | A | Exact ingredient | 2025/03/02 | CDE |
| 地氯雷他定 | 合肥恩瑞特药业有限公司 | Y20180001686 | A | Exact ingredient | 2026/04/20 | CDE |
| 地氯雷他定 | 海南普利制药股份有限公司 | Y20180000812 | A | Exact ingredient | 2025/10/14 | CDE |
| 地氯雷他定 | 山东朗诺制药有限公司 | Y20180000860 | A | Exact ingredient | 2026/03/13 | CDE |
| 地氯雷他定 | 山东达因海洋生物制药股份有限公司 | Y20170000877 | A | Exact ingredient | 2024/09/20 | CDE |
| 地氯雷他定 | 四川成都同道堂制药有限责任公司 | Y20170000256 | A | Exact ingredient | 2022/09/05 | CDE |
| 地氯雷他定 | Morepen Laboratories Ltd | Y20170000139 | A | Exact ingredient | 2024/06/28 | CDE |
| 地氯雷他定 | Cadila Pharmaceuticals Limited | Y20170000068 | A | Exact ingredient | 2024/06/23 | CDE |
| 地氯雷他定 | 苏州二叶制药有限公司 | Y20170000005 | I | Exact ingredient | — | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
What changed recently?
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/10/21Accepted
恒昌（广州）新药研究有限公司;浙江康恩贝制药股份有限公司
CYHB2601919
Fact date: 2026/10/21 · Site observation date: 2026/10/22
View source ↗ -
2026/10/21Accepted
恒昌（广州）新药研究有限公司;浙江康恩贝制药股份有限公司
CYHB2601918
Fact date: 2026/10/21 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/10 07:27
- Chemical-drug catalogue
- Last successful update: 2026/11/10 07:23
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/10 07:25
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/10 18:31
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/10 08:10 · Current coverage may be incomplete
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 3/30; discovered pending details: 20. Record counts in unscanned portions remain unknown.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
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.
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