Monthly
US$200
Billed every month
Fexofenadine Hydrochloride Tablets(盐酸非索非那定片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 4 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 holders4View records ↓
Under-review filings10View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers16View records ↓
API companies with A status17View records ↓
Chemical-drug catalogue
Loaded records: 4 holders; 4 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 |
|---|---|---|---|---|---|---|
| 浙江万晟药业有限公司 | 浙江万晟药业有限公司 | 国药准字H20060149 | 2024/01/11 | 60mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 浙江万晟药业有限公司 | 浙江万晟药业有限公司 | 国药准字H20060150 | 2024/01/11 | 30mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 四川省旭晖制药有限公司 | 四川省旭晖制药有限公司 | 国药准字H20070124 | 2023/09/20 | 60mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 成都盛迪医药有限公司 | 成都盛迪医药有限公司 | 国药准字H20153221 | 2021/11/29 | 60mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 西安万隆制药股份有限公司 | 西安万隆制药股份有限公司 | 国药准字H20080710 | 2021/01/15 | 60mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | 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: 16 distinct approval numbers and 11 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京福元医药股份有限公司 | 国药准字H20130040 | 60mg | Not stated by source | XR06AXF024A001010100177 | NHSA |
| 太极集团重庆涪陵制药厂有限公司 | 国药准字H20060330 | 60mg | Not stated by source | XR06AXF024A001010100973 | NHSA |
| 重庆科瑞制药(集团)有限公司 | 国药准字H20080437 | 120mg | Not stated by source | XR06AXF024A001010101016 | NHSA |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170079 | 120mg | Not stated by source | XR06AXF024A001010101533 | NHSA |
| 西安万隆制药股份有限公司 | 国药准字H20080710 | 60mg | Not stated by source | XR06AXF024A001010102525 | NHSA |
| 四川省旭晖制药有限公司 | 国药准字H20070124 | 60mg | Not stated by source | XR06AXF024A001010104065 | NHSA |
| 浙江三生蔓迪药业有限公司 | 国药准字H20060150 | 30mg | Not stated by source | XR06AXF024A001010104726 | NHSA |
| 云南裕丰药业有限公司 | 国药准字H20080123 | 30mg | Not stated by source | XR06AXF024A001010105710 | NHSA |
| OPELLA HEALTHCARE FRANCE SAS | 国药准字HJ20210012 | 180mg | Not stated by source | XR06AXF024A001010178821 | NHSA |
| 成都盛迪医药有限公司 | 国药准字H20153221 | 60mg | Not stated by source | XR06AXF024A001010180435 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20130040 | 60mg | Not stated by source | XR06AXF024A001010200177 | NHSA |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170079 | 120mg | Not stated by source | XR06AXF024A001010201533 | NHSA |
| 西安万隆制药股份有限公司 | 国药准字H20080710 | 60mg | Not stated by source | XR06AXF024A001010202525 | NHSA |
| 黑龙江乌苏里江制药有限公司哈尔滨分公司 | 国药准字H20090333 | 60mg | Not stated by source | XR06AXF024A001010203795 | NHSA |
| 四川省旭晖制药有限公司 | 国药准字H20070124 | 60mg | Not stated by source | XR06AXF024A001010204065 | NHSA |
| 浙江三生蔓迪药业有限公司 | 国药准字H20060150 | 30mg | Not stated by source | XR06AXF024A001010204726 | NHSA |
| 云南裕丰药业有限公司 | 国药准字H20080123 | 30mg | Not stated by source | XR06AXF024A001010205710 | NHSA |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170077 | 60mg | Not stated by source | XR06AXF024A001010278770 | NHSA |
| OPELLA HEALTHCARE FRANCE SAS | 国药准字HJ20210012 | 180mg | Not stated by source | XR06AXF024A001010278821 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20130040 | 60mg | Not stated by source | XR06AXF024A001010300177 | NHSA |
| 西安万隆制药股份有限公司 | 国药准字H20080710 | 60mg | Not stated by source | XR06AXF024A001010302525 | NHSA |
| 黑龙江乌苏里江制药有限公司哈尔滨分公司 | 国药准字H20090333 | 60mg | Not stated by source | XR06AXF024A001010303795 | NHSA |
| 四川省旭晖制药有限公司 | 国药准字H20070124 | 60mg | Not stated by source | XR06AXF024A001010304065 | NHSA |
| 浙江三生蔓迪药业有限公司 | 国药准字H20060150 | 30mg | Not stated by source | XR06AXF024A001010304726 | NHSA |
| 云南裕丰药业有限公司 | 国药准字H20080123 | 30mg | Not stated by source | XR06AXF024A001010305710 | NHSA |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170077 | 60mg | Not stated by source | XR06AXF024A001010378770 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20130040 | 60mg | Not stated by source | XR06AXF024A001010400177 | NHSA |
| 黑龙江乌苏里江制药有限公司哈尔滨分公司 | 国药准字H20090333 | 60mg | Not stated by source | XR06AXF024A001010403795 | NHSA |
| 四川省旭晖制药有限公司 | 国药准字H20070124 | 60mg | Not stated by source | XR06AXF024A001010404065 | NHSA |
| 浙江三生蔓迪药业有限公司 | 国药准字H20060150 | 30mg | Not stated by source | XR06AXF024A001010404726 | NHSA |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170077 | 60mg | Not stated by source | XR06AXF024A001010478770 | NHSA |
| 黑龙江乌苏里江制药有限公司哈尔滨分公司 | 国药准字H20090333 | 60mg | Not stated by source | XR06AXF024A001010503795 | NHSA |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170077 | 60mg | Not stated by source | XR06AXF024A001010578770 | NHSA |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170077 | 60mg | Not stated by source | XR06AXF024A001010778770 | NHSA |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170077 | 60mg | Not stated by source | XR06AXF024A001010878770 | NHSA |
| Sun Pharmaceutical Industries Ltd. | 国药准字J20170035 | 60mg | Not stated by source | XR06AXF024A001020101533 | NHSA |
| 浙江三生蔓迪药业有限公司 | 国药准字H20060149 | 60mg | Not stated by source | XR06AXF024A001020104726 | NHSA |
| Sun Pharmaceutical Industries Ltd. | H20170079 | 120mg | Not stated by source | XR06AXF024A001020178770 | NHSA |
| 浙江三生蔓迪药业有限公司 | 国药准字H20060149 | 60mg | Not stated by source | XR06AXF024A001020204726 | NHSA |
| Sun Pharmaceutical Industries Ltd. | H20170079 | 120mg | Not stated by source | XR06AXF024A001020278770 | NHSA |
| 浙江三生蔓迪药业有限公司 | 国药准字H20060149 | 60mg | Not stated by source | XR06AXF024A001020304726 | NHSA |
| Sun Pharmaceutical Industries Ltd. | 国药准字HJ20170080 | 120mg | Not stated by source | XR06AXF024A001020378770 | NHSA |
| 浙江三生蔓迪药业有限公司 | 国药准字H20060149 | 60mg | Not stated by source | XR06AXF024A001020404726 | 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: 10 filings and 4 distinct first applicants.
Import re-registration 2 · Generic 8
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES LIMITED | JYHZ2600273 | Import re-registration | 2026/10/21 | Not stated by source | CDE |
| SUN PHARMACEUTICAL INDUSTRIES LIMITED | JYHZ2600272 | Import re-registration | 2026/10/21 | Not stated by source | CDE |
| 合肥合源药业有限公司 | CYHS2602222 | Generic | 2026/09/07 | Not stated by source | CDE |
| 合肥合源药业有限公司 | CYHS2602220 | Generic | 2026/09/07 | Not stated by source | CDE |
| 北京四环科宝制药股份有限公司;安徽四环科宝制药有限公司 | CYHS2601983 | Generic | 2026/08/12 | Not stated by source | CDE |
| 北京四环科宝制药股份有限公司;安徽四环科宝制药有限公司 | CYHS2601982 | Generic | 2026/08/12 | Not stated by source | CDE |
| 植恩生物技术股份有限公司 | CYHS2503071 | Generic | 2025/08/21 | Not stated by source | CDE |
| 植恩生物技术股份有限公司 | CYHS2503070 | Generic | 2025/08/21 | Not stated by source | CDE |
| 植恩生物技术股份有限公司 | CYHS2503069 | Generic | 2025/08/21 | Not stated by source | CDE |
| 植恩生物技术股份有限公司 | CYHS2503068 | Generic | 2025/08/21 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 合肥合源药业有限公司 | CYHS2602222 | Generic | 2026/09/07 | Not stated by source | CDE |
| 合肥合源药业有限公司 | CYHS2602220 | Generic | 2026/09/07 | Not stated by source | CDE |
| 北京四环科宝制药股份有限公司;安徽四环科宝制药有限公司 | CYHS2601983 | Generic | 2026/08/12 | Not stated by source | CDE |
| 北京四环科宝制药股份有限公司;安徽四环科宝制药有限公司 | CYHS2601982 | Generic | 2026/08/12 | Not stated by source | CDE |
API registrations
Non-component matches: 17 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 盐酸非索非那定 | M/s. Morepen Laboratories Ltd | Y20240001525 | I | Exact ingredient | 2025/03/05 | CDE |
| 盐酸非索非那定 | Chemeca Drugs Private Limited | Y20230000849 | A | Exact ingredient | 2026/10/15 | CDE |
| 盐酸非索非那定 | Vasudha Pharma Chem Ltd. | Y20220001219 | A | Exact ingredient | 2025/08/06 | CDE |
| 盐酸非索非那定 | 西安万隆制药股份有限公司 | Y20220000912 | A | Exact ingredient | 2024/06/07 | CDE |
| 盐酸非索非那定 | Ind-Swift Laboratories Limited | Y20190009263 | A | Exact ingredient | 2023/08/10 | CDE |
| 盐酸非索非那定 | Synthimed Labs Private Limited | Y20190009262 | A | Exact ingredient | 2026/08/11 | CDE |
| 盐酸非索非那定 | 浙江乐普药业股份有限公司 | Y20190007452 | A | Exact ingredient | 2024/02/28 | CDE |
| 盐酸非索非那定 | 浙江华海药业股份有限公司 | Y20190007370 | A | Exact ingredient | 2023/07/18 | CDE |
| 盐酸非索非那定 | 海南沙汀宁制药有限公司 | Y20190007145 | A | Exact ingredient | — | CDE |
| 盐酸非索非那定 | 北京福元医药股份有限公司 | Y20190007111 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸非索非那定 | 万特制药（海南）有限公司 | Y20190006884 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸非索非那定 | 四川省旭晖制药有限公司 | Y20190006660 | A | Exact ingredient | — | CDE |
| 盐酸非索非那定 | 重庆植恩药业有限公司 | Y20190006653 | A | Exact ingredient | — | CDE |
| 盐酸非索非那定 | 池州东升药业有限公司 | Y20190006585 | A | Exact ingredient | 2026/04/20 | CDE |
| 盐酸非索非那定 | 江苏天士力帝益药业有限公司 | Y20190006077 | A | Exact ingredient | 2025/08/22 | CDE |
| 盐酸非索非那定 | 江苏恒瑞医药股份有限公司 | Y20190004696 | A | Exact ingredient | 2025/08/01 | CDE |
| 盐酸非索非那定 | 太极集团重庆涪陵制药厂有限公司 | Y20190004565 | A | Exact ingredient | 2025/02/06 | CDE |
| 盐酸非索非那定 | Virupaksha Organics Ltd | Y20170000127 | A | Exact ingredient | 2026/08/07 | 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
SUN PHARMACEUTICAL INDUSTRIES LIMITED
JYHZ2600273
Fact date: 2026/10/21 · Site observation date: 2026/10/22
View source ↗ -
2026/10/21Accepted
SUN PHARMACEUTICAL INDUSTRIES LIMITED
JYHZ2600272
Fact date: 2026/10/21 · Site observation date: 2026/10/22
View source ↗ -
2026/09/07Accepted
-
2026/09/07Accepted
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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