Monthly
US$200
Billed every month
Ezetimibe Tablets(依折麦布片)
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 holders21View records ↓
Under-review filings4View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers23View records ↓
API companies with A status20View records ↓
Chemical-drug catalogue
Loaded records: 21 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 19 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 |
|---|---|---|---|---|---|---|
| 湖南千金湘江药业股份有限公司 | 湖南千金湘江药业股份有限公司 | 国药准字H20265564 | 2026/08/04 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 北京亚宝生物药业有限公司 | 北京亚宝生物药业有限公司 | 国药准字H20264396 | 2026/05/19 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 华润赛科药业有限责任公司 | 华润赛科药业有限责任公司 | 国药准字H20264237 | 2026/05/07 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| Hetero Labs Limited | Hetero Labs Limited | 国药准字HJ20260034 | 2026/04/14 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 江西施美药业股份有限公司 | 江西施美药业股份有限公司 | 国药准字H20263459 | 2026/02/25 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 翎耀生物科技（上海）有限公司 | 江苏复旦复华药业有限公司 | 国药准字H20256139 | 2025/12/03 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 山东鲁抗医药股份有限公司 | 山东鲁抗医药股份有限公司 | 国药准字H20253162 | 2025/01/14 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 云南龙津康佑生物医药有限公司 | 昆明龙津药业股份有限公司 | 国药准字H20249818 | 2024/12/25 | 10mg | Not stated by source | CDE |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20249737 | 2024/12/17 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 江苏德源药业股份有限公司 | 江苏德源药业股份有限公司 | 国药准字H20249498 | 2024/12/01 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 北京百奥药业有限责任公司 | 无锡福祈制药有限公司 | 国药准字H20249171 | 2024/10/22 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 常州制药厂有限公司 | 常州制药厂有限公司 | 国药准字H20244067 | 2024/06/18 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 山东丹红制药有限公司 | 山东步长制药股份有限公司 | 国药准字H20243762 | 2024/05/21 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江诺得药业有限公司 | 浙江诺得药业有限公司 | 国药准字H20243253 | 2024/02/23 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 南京海鲸药业股份有限公司 | 杭州民生药业股份有限公司 | 国药准字H20233164 | 2023/02/14 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 苏州华健瑞达医药技术有限公司 | 江苏吴中医药集团有限公司苏州制药厂 | 国药准字H20213760 | 2021/09/30 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 北京福元医药股份有限公司 | 北京福元医药股份有限公司 | 国药准字H20213584 | 2021/07/20 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 重庆圣华曦药业股份有限公司 | 重庆圣华曦药业股份有限公司 | 国药准字H20213585 | 2021/07/20 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| Sandoz Inc. | Lek Pharmaceuticals d. d. | 国药准字HJ20210050 | 2021/06/29 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 湖南方盛制药股份有限公司 | 湖南方盛制药股份有限公司 | 国药准字H20203468 | 2020/09/08 | 10mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| MSD Pharma (Singapore) Pte. Ltd. | MSD International GmbH (Singapore Branch) | H20160181 | 2006/04/06 | 10mg | Imported originator drug (进口原研药品) | CDE |
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: 23 distinct approval numbers and 23 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 华润赛科药业有限责任公司 | 国药准字H20264237 | 10mg | Category B (乙) | XC10AXY097A001010100111 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20213584 | 10mg | Category B (乙) | XC10AXY097A001010100177 | NHSA |
| 常州制药厂有限公司 | 国药准字H20244067 | 10mg | Category B (乙) | XC10AXY097A001010101397 | NHSA |
| 四川美大康华康药业有限公司 | 国药准字H20213760 | 10mg | Category B (乙) | XC10AXY097A001010101504 | NHSA |
| 山东新鲁医药科技有限公司 | 国药准字H20233164 | 10mg | Category B (乙) | XC10AXY097A001010101564 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249737 | 10mg | Category B (乙) | XC10AXY097A001010104188 | NHSA |
| MSD Pharma(Singapore) Pte. Ltd. | 国药准字J20171023 | 10mg | Category B (乙) | XC10AXY097A001010104495 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001010104920 | NHSA |
| 湖南千金湘江药业股份有限公司 | 国药准字H20265564 | 10mg | Category B (乙) | XC10AXY097A001010104960 | NHSA |
| 江西施美药业股份有限公司 | 国药准字H20263459 | 10mg | Category B (乙) | XC10AXY097A001010105356 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20249498 | 10mg | Category B (乙) | XC10AXY097A001010106632 | NHSA |
| 北京亚宝生物药业有限公司 | 国药准字H20264396 | 10mg | Category B (乙) | XC10AXY097A001010109542 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20213585 | 10mg | Category B (乙) | XC10AXY097A001010109568 | NHSA |
| MSD International GmbH (Singapore Branch) | H20160181 | 10mg | Category B (乙) | XC10AXY097A001010178893 | NHSA |
| Hetero Labs Limited | 国药准字HJ20260034 | 10mg | Category B (乙) | XC10AXY097A001010179426 | NHSA |
| 山东丹红制药有限公司 | 国药准字H20243762 | 10mg | Category B (乙) | XC10AXY097A001010180472 | NHSA |
| 北京百奥药业有限责任公司 | 国药准字H20249171 | 10mg | Category B (乙) | XC10AXY097A001010183058 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20253162 | 10mg | Category B (乙) | XC10AXY097A001010183198 | NHSA |
| 翎耀生物科技(上海)有限公司 | 国药准字H20256139 | 10mg | Category B (乙) | XC10AXY097A001010183356 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001010183521 | NHSA |
| Sandoz Inc. | 国药准字HJ20210050 | 10mg | Category B (乙) | XC10AXY097A001010183662 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249818 | 10mg | Category B (乙) | XC10AXY097A001010184548 | NHSA |
| 华润赛科药业有限责任公司 | 国药准字H20264237 | 10mg | Category B (乙) | XC10AXY097A001010200111 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20213584 | 10mg | Category B (乙) | XC10AXY097A001010200177 | NHSA |
| 常州制药厂有限公司 | 国药准字H20244067 | 10mg | Category B (乙) | XC10AXY097A001010201397 | NHSA |
| 四川美大康华康药业有限公司 | 国药准字H20213760 | 10mg | Category B (乙) | XC10AXY097A001010201504 | NHSA |
| 山东新鲁医药科技有限公司 | 国药准字H20233164 | 10mg | Category B (乙) | XC10AXY097A001010201564 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249737 | 10mg | Category B (乙) | XC10AXY097A001010204188 | NHSA |
| MSD Pharma(Singapore) Pte. Ltd. | 国药准字J20171023 | 10mg | Category B (乙) | XC10AXY097A001010204495 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001010204920 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20249498 | 10mg | Category B (乙) | XC10AXY097A001010206632 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20213585 | 10mg | Category B (乙) | XC10AXY097A001010209568 | NHSA |
| MSD International GmbH (Singapore Branch) | H20160181 | 10mg | Category B (乙) | XC10AXY097A001010278893 | NHSA |
| Hetero Labs Limited | 国药准字HJ20260034 | 10mg | Category B (乙) | XC10AXY097A001010279426 | NHSA |
| 北京百奥药业有限责任公司 | 国药准字H20249171 | 10mg | Category B (乙) | XC10AXY097A001010283058 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20253162 | 10mg | Category B (乙) | XC10AXY097A001010283198 | NHSA |
| 翎耀生物科技(上海)有限公司 | 国药准字H20256139 | 10mg | Category B (乙) | XC10AXY097A001010283356 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001010283521 | NHSA |
| Sandoz Inc. | 国药准字HJ20210050 | 10mg | Category B (乙) | XC10AXY097A001010283662 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249818 | 10mg | Category B (乙) | XC10AXY097A001010284548 | NHSA |
| 华润赛科药业有限责任公司 | 国药准字H20264237 | 10mg | Category B (乙) | XC10AXY097A001010300111 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20213584 | 10mg | Category B (乙) | XC10AXY097A001010300177 | NHSA |
| 常州制药厂有限公司 | 国药准字H20244067 | 10mg | Category B (乙) | XC10AXY097A001010301397 | NHSA |
| 四川美大康华康药业有限公司 | 国药准字H20213760 | 10mg | Category B (乙) | XC10AXY097A001010301504 | NHSA |
| 山东新鲁医药科技有限公司 | 国药准字H20233164 | 10mg | Category B (乙) | XC10AXY097A001010301564 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249737 | 10mg | Category B (乙) | XC10AXY097A001010304188 | NHSA |
| MSD Pharma(Singapore) Pte. Ltd. | 国药准字J20171023 | 10mg | Category B (乙) | XC10AXY097A001010304495 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001010304920 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20249498 | 10mg | Category B (乙) | XC10AXY097A001010306632 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20213585 | 10mg | Category B (乙) | XC10AXY097A001010309568 | NHSA |
| ORGANON SINGAPORE PTE. LTD. | 国药准字HJ20160181 | 10mg | Category B (乙) | XC10AXY097A001010378893 | NHSA |
| 北京百奥药业有限责任公司 | 国药准字H20249171 | 10mg | Category B (乙) | XC10AXY097A001010383058 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20253162 | 10mg | Category B (乙) | XC10AXY097A001010383198 | NHSA |
| 翎耀生物科技(上海)有限公司 | 国药准字H20256139 | 10mg | Category B (乙) | XC10AXY097A001010383356 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001010383521 | NHSA |
| Sandoz Inc. | 国药准字HJ20210050 | 10mg | Category B (乙) | XC10AXY097A001010383662 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249818 | 10mg | Category B (乙) | XC10AXY097A001010384548 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20213584 | 10mg | Category B (乙) | XC10AXY097A001010400177 | NHSA |
| 常州制药厂有限公司 | 国药准字H20244067 | 10mg | Category B (乙) | XC10AXY097A001010401397 | NHSA |
| 四川美大康华康药业有限公司 | 国药准字H20213760 | 10mg | Category B (乙) | XC10AXY097A001010401504 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249737 | 10mg | Category B (乙) | XC10AXY097A001010404188 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001010404920 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20249498 | 10mg | Category B (乙) | XC10AXY097A001010406632 | NHSA |
| 重庆圣华曦药业股份有限公司 | 国药准字H20213585 | 10mg | Category B (乙) | XC10AXY097A001010409568 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20253162 | 10mg | Category B (乙) | XC10AXY097A001010483198 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001010483521 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249818 | 10mg | Category B (乙) | XC10AXY097A001010484548 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20213584 | 10mg | Category B (乙) | XC10AXY097A001010500177 | NHSA |
| 常州制药厂有限公司 | 国药准字H20244067 | 10mg | Category B (乙) | XC10AXY097A001010501397 | NHSA |
| 四川美大康华康药业有限公司 | 国药准字H20213760 | 10mg | Category B (乙) | XC10AXY097A001010501504 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249737 | 10mg | Category B (乙) | XC10AXY097A001010504188 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001010504920 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20249498 | 10mg | Category B (乙) | XC10AXY097A001010506632 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001010583521 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249818 | 10mg | Category B (乙) | XC10AXY097A001010584548 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249737 | 10mg | Category B (乙) | XC10AXY097A001010604188 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001010604920 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20249498 | 10mg | Category B (乙) | XC10AXY097A001010606632 | NHSA |
| ORGANON SINGAPORE PTE. LTD. | 国药准字HJ20160181 | 10mg | Category B (乙) | XC10AXY097A001010678893 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001010683521 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249818 | 10mg | Category B (乙) | XC10AXY097A001010684548 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249737 | 10mg | Category B (乙) | XC10AXY097A001010704188 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001010704920 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20249498 | 10mg | Category B (乙) | XC10AXY097A001010706632 | NHSA |
| ORGANON SINGAPORE PTE. LTD. | 国药准字HJ20160181 | 10mg | Category B (乙) | XC10AXY097A001010778893 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001010783521 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249818 | 10mg | Category B (乙) | XC10AXY097A001010784548 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249737 | 10mg | Category B (乙) | XC10AXY097A001010804188 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001010804920 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20249498 | 10mg | Category B (乙) | XC10AXY097A001010806632 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001010883521 | NHSA |
| 云南龙津康佑生物医药有限公司 | 国药准字H20249818 | 10mg | Category B (乙) | XC10AXY097A001010884548 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20249737 | 10mg | Category B (乙) | XC10AXY097A001010904188 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001010904920 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20249498 | 10mg | Category B (乙) | XC10AXY097A001010906632 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001010983521 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001011004920 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001011083521 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001011104920 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001011183521 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001011204920 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001011283521 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001011304920 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001011383521 | NHSA |
| 湖南方盛制药股份有限公司 | 国药准字H20203468 | 10mg | Category B (乙) | XC10AXY097A001011404920 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001011483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001011583521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001011683521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001011783521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001011883521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001011983521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001012083521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001012183521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001012283521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001012383521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001012483521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001012583521 | NHSA |
| 浙江诺得药业有限公司 | 国药准字H20243253 | 10mg | Category B (乙) | XC10AXY097A001012683521 | 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: 4 filings and 4 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海鲸药业股份有限公司 | CYHS2601395 | Generic | 2026/06/12 | Not stated by source | CDE |
| 浙江江北药业有限公司 | CYHS2602544 | Generic | 2026/10/14 | Not stated by source | CDE |
| 海南赛立克药业有限公司 | CYHS2504117 | Generic | 2025/12/02 | Not stated by source | CDE |
| 国药集团致君（深圳）制药有限公司;国药集团致君（深圳）坪山制药有限公司 | CYHS2602594 | Generic | 2026/10/22 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京海鲸药业股份有限公司 | CYHS2601395 | Generic | 2026/06/12 | Not stated by source | CDE |
| 浙江江北药业有限公司 | CYHS2602544 | Generic | 2026/10/14 | Not stated by source | CDE |
| 国药集团致君（深圳）制药有限公司;国药集团致君（深圳）坪山制药有限公司 | CYHS2602594 | Generic | 2026/10/22 | Not stated by source | CDE |
API registrations
Non-component matches: 20 companies with A status and 6 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 |
|---|---|---|---|---|---|---|
| 依折麦布 | 江苏诺泰澳赛诺生物制药股份有限公司 | Y20260000100 | I | Exact ingredient | 2026/02/11 | CDE |
| 依折麦布 | 浙江天宇药业股份有限公司 | Y20250000915 | I | Exact ingredient | 2025/10/30 | CDE |
| 依折麦布 | 云鹏医药集团有限公司 | Y20250000047 | A | Exact ingredient | 2026/07/20 | CDE |
| 依折麦布 | 天方药业有限公司 | Y20240001567 | A | Exact ingredient | 2026/07/14 | CDE |
| 依折麦布 | Saptagir Laboratories Pvt. Ltd. | Y20240000581 | I | Exact ingredient | 2026/04/03 | CDE |
| 依折麦布 | 浙江京圣药业有限公司 | Y20230001252 | A | Exact ingredient | 2025/07/11 | CDE |
| 依折麦布 | 江苏德源药业股份有限公司 | Y20230000515 | A | Exact ingredient | 2024/09/02 | CDE |
| 依折麦布 | Apitoria Pharma Private Limited | Y20230000079 | A | Exact ingredient | 2025/01/06 | CDE |
| 依折麦布 | Hetero Labs Limited | Y20220000766 | A | Exact ingredient | 2026/03/19 | CDE |
| 依折麦布 | 亚宝药业集团股份有限公司 | Y20220000666 | A | Exact ingredient | 2026/02/10 | CDE |
| 依折麦布 | 南通常佑药业科技有限公司 | Y20210000966 | A | Exact ingredient | 2023/08/29 | CDE |
| 依折麦布 | Hanmi Fine Chemical Co., Ltd. | Y20200001433 | A | Exact ingredient | 2024/10/24 | CDE |
| 依折麦布 | 山东新时代药业有限公司 | Y20210000182 | A | Exact ingredient | 2022/11/02 | CDE |
| 依折麦布 | 南京优科制药有限公司 | Y20210000199 | A | Exact ingredient | 2023/02/21 | CDE |
| 依折麦布 | LUPIN LIMITED | Y20210000140 | A | Exact ingredient | 2025/05/17 | CDE |
| 依折麦布 | 山东铂源药业股份有限公司 | Y20200001270 | A | Exact ingredient | 2024/02/27 | CDE |
| 依折麦布 | Synthimed Labs Private Limited | Y20200001218 | A | Exact ingredient | 2026/07/17 | CDE |
| 依折麦布 | Neuland Laboratories Ltd | Y20200000801 | I | Exact ingredient | 2020/12/22 | CDE |
| 依折麦布 | 无锡福祈制药有限公司 | Y20200000290 | A | Exact ingredient | 2022/10/27 | CDE |
| 依折麦布 | 浙江天宇药业股份有限公司 | Y20190000721 | A | Exact ingredient | 2026/01/06 | CDE |
| 依折麦布 | 重庆圣华曦药业股份有限公司 | Y20190000874 | A | Exact ingredient | 2026/04/30 | CDE |
| 依折麦布 | TEVA API INDIA PRIVATE LIMITED | Y20190000329 | A | Exact ingredient | 2026/07/15 | CDE |
| 依折麦布 | Aurobindo Pharma Limited | Y20180001595 | I | Exact ingredient | 2019/03/20 | CDE |
| 依折麦布 | 湖南方盛制药股份有限公司 | Y20190000024 | A | Exact ingredient | 2025/09/16 | CDE |
| 依折麦布 | MSN Laboratories Private Limited颐德药业（上海）有限公司 | Y20180001083 | A | Exact ingredient | 2025/07/30 | CDE |
| 依折麦布 | 山东朗诺制药有限公司 | Y20180001036 | I | Exact ingredient | 2018/08/30 | 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.
-
2026/10/22Accepted
国药集团致君（深圳）制药有限公司;国药集团致君（深圳）坪山制药有限公司
CYHS2602594
Fact date: 2026/10/22 · Site observation date: 2026/10/23
View source ↗ -
2026/10/14Accepted
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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