Monthly
US$200
Billed every month
盐酸特比萘芬喷雾剂
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 application
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 filings7View records ↓
This year’s generic filers4View records ↓
NHSA approval numbers19View records ↓
API companies with A status22View 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: 19 distinct approval numbers and 19 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Hanmi Pharm. Co., Ltd. | 国药准字J20150008 | 1%(g:g) | Not stated by source | XD01AET021L002010100041 | NHSA |
| 广东彼迪药业有限公司 | 国药准字H20020139 | 10ml:0.10g;15ml:0.15g | Not stated by source | XD01AET021L002010100269 | NHSA |
| 华润三九医药股份有限公司 | 国药准字H20243146 | 每瓶为30ml,1克喷雾剂含10毫克盐酸特比萘芬 | Not stated by source | XD01AET021L002010100474 | NHSA |
| 江苏晨牌邦德药业有限公司 | 国药准字H20093612 | 15ml:0.15g | Not stated by source | XD01AET021L002010101427 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H20173127 | 1%(15毫升:0.15克) | Not stated by source | XD01AET021L002010101564 | NHSA |
| 华东医药(西安)博华制药有限公司 | 国药准字H20265014 | 1%(g:g;每瓶30ml) | Not stated by source | XD01AET021L002010102469 | NHSA |
| 保定天浩制药有限公司 | 国药准字H20265769 | 1%(g:g;每瓶30ml) | Not stated by source | XD01AET021L002010102551 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20000335 | 15ml: 0.15g | Not stated by source | XD01AET021L002010104021 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20113280 | 1% | Not stated by source | XD01AET021L002010104111 | NHSA |
| 浙江苏可安药业有限公司 | 国药准字H20163114 | 1% | Not stated by source | XD01AET021L002010104681 | NHSA |
| 厦门美商医药有限公司 | 国药准字H20103594 | 1% | Not stated by source | XD01AET021L002010107566 | NHSA |
| 福元药业有限公司 | 国药准字H20213015 | 1%(g:g,每瓶15ml) | Not stated by source | XD01AET021L002010180651 | NHSA |
| GlaxoSmithKline Consumer Healthcare (UK) Trading Limited | 国药准字HJ20170204 | 1克喷雾剂含10毫克盐酸特比萘芬 | Not stated by source | XD01AET021L002010181755 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20255082 | 1%(g:g;每瓶30ml) | Not stated by source | XD01AET021L002010184211 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20255874 | 1%(g:g;每瓶30ml) | Not stated by source | XD01AET021L002010184221 | NHSA |
| 山西振东安欣生物制药有限公司 | 国药准字H20243145 | 每瓶为30毫升,每克喷雾剂含10毫克盐酸特比萘芬 | Not stated by source | XD01AET021L002010184227 | NHSA |
| 浙江寰领医药科技有限公司 | 国药准字H20255519 | 1%(g:g;每瓶30ml) | Not stated by source | XD01AET021L002010184239 | NHSA |
| 苏州高迈药业有限公司 | 国药准字H20265631 | 1%(g:g;每瓶30ml) | Not stated by source | XD01AET021L002010184410 | NHSA |
| 湖南及正医药科技有限公司 | 国药准字H20244782 | 1%(g:g;每瓶30ml) | Not stated by source | XD01AET021L002010184994 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20000335 | 15ml: 0.15g | Not stated by source | XD01AET021L002010204021 | NHSA |
| 浙江百代医药科技有限公司 | 国药准字H20255082 | 1%(g:g;每瓶30ml) | Not stated by source | XD01AET021L002010284211 | NHSA |
| 浙江寰领医药科技有限公司 | 国药准字H20255519 | 1%(g:g;每瓶30ml) | Not stated by source | XD01AET021L002010284239 | NHSA |
| 广东彼迪药业有限公司 | 国药准字H20020139 | 10ml:0.10g;15ml:0.15g | Not stated by source | XD01AET021L002020100269 | NHSA |
| 江苏晨牌邦德药业有限公司 | 国药准字H20093612 | 15ml:0.15g | Not stated by source | XD01AET021L002020101427 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H20173127 | 1%(15毫升:0.15克) | Not stated by source | XD01AET021L002020101564 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20000335 | 15ml: 0.15g | Not stated by source | XD01AET021L002020104021 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20113280 | 1% | Not stated by source | XD01AET021L002020104111 | NHSA |
| 浙江苏可安药业有限公司 | 国药准字H20163114 | 1% | Not stated by source | XD01AET021L002020104681 | NHSA |
| 厦门美商医药有限公司 | 国药准字H20103594 | 1% | Not stated by source | XD01AET021L002020107566 | NHSA |
| 福元药业有限公司 | 国药准字H20213015 | 1%(g:g,每瓶15ml) | Not stated by source | XD01AET021L002020180651 | NHSA |
| GlaxoSmithKline Consumer Healthcare (UK) Trading Limited | 国药准字HJ20170204 | 1克喷雾剂含10毫克盐酸特比萘芬 | Not stated by source | XD01AET021L002020181755 | NHSA |
| 湖南及正医药科技有限公司 | 国药准字H20244782 | 1%(g:g;每瓶30ml) | Not stated by source | XD01AET021L002020184994 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H20173127 | 1%(15毫升:0.15克) | Not stated by source | XD01AET021L002020201564 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20113280 | 1% | Not stated by source | XD01AET021L002020204111 | NHSA |
| 广东彼迪药业有限公司 | 国药准字H20020139 | 10ml:0.10g;15ml:0.15g | Not stated by source | XD01AET021L002030100269 | NHSA |
| 江苏晨牌邦德药业有限公司 | 国药准字H20093612 | 15ml:0.15g | Not stated by source | XD01AET021L002030101427 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H20173127 | 1%(15毫升:0.15克) | Not stated by source | XD01AET021L002030101564 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20000335 | 15ml: 0.15g | Not stated by source | XD01AET021L002030104021 | NHSA |
| 浙江苏可安药业有限公司 | 国药准字H20163114 | 1% | Not stated by source | XD01AET021L002030104681 | NHSA |
| 厦门美商医药有限公司 | 国药准字H20103594 | 1% | Not stated by source | XD01AET021L002030107566 | NHSA |
| 福元药业有限公司 | 国药准字H20213015 | 1%(g:g,每瓶15ml) | Not stated by source | XD01AET021L002030180651 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20000335 | 15ml: 0.15g | Not stated by source | XD01AET021L002030204021 | NHSA |
| 广东彼迪药业有限公司 | 国药准字H20020139 | 10ml:0.10g;15ml:0.15g | Not stated by source | XD01AET021L002040100269 | NHSA |
| 江苏晨牌邦德药业有限公司 | 国药准字H20093612 | 15ml:0.15g | Not stated by source | XD01AET021L002040101427 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H20173127 | 1%(15毫升:0.15克) | Not stated by source | XD01AET021L002040101564 | NHSA |
| 浙江苏可安药业有限公司 | 国药准字H20163114 | 1% | Not stated by source | XD01AET021L002040104681 | NHSA |
| 厦门美商医药有限公司 | 国药准字H20103594 | 1% | Not stated by source | XD01AET021L002040107566 | NHSA |
| 福元药业有限公司 | 国药准字H20213015 | 1%(g:g,每瓶15ml) | Not stated by source | XD01AET021L002040180651 | NHSA |
| 江苏晨牌邦德药业有限公司 | 国药准字H20093612 | 15ml:0.15g | Not stated by source | XD01AET021L002050101427 | NHSA |
| 江苏知原药业股份有限公司 | 国药准字H20173127 | 1%(15毫升:0.15克) | Not stated by source | XD01AET021L002050101564 | NHSA |
| 浙江苏可安药业有限公司 | 国药准字H20163114 | 1% | Not stated by source | XD01AET021L002050104681 | NHSA |
| 福元药业有限公司 | 国药准字H20213015 | 1%(g:g,每瓶15ml) | Not stated by source | XD01AET021L002050180651 | NHSA |
| 江苏晨牌邦德药业有限公司 | 国药准字H20093612 | 15ml:0.15g | Not stated by source | XD01AET021L002060101427 | 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: 7 filings and 6 distinct first applicants.
Generic 6 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 湖北康正药业有限公司 | CYHS2600990 | Generic | 2026/04/28 | Not stated by source | CDE |
| 湖北华傲制药有限公司;浙江赛默制药有限公司 | CYHS2600803 | Generic | 2026/04/09 | Not stated by source | CDE |
| 厦门美商医药有限公司 | CYHB2600549 | Supplement | 2026/03/20 | Not stated by source | CDE |
| 武汉诺安药业有限公司 | CYHS2600576 | Generic | 2026/02/28 | Not stated by source | CDE |
| 济南中海医药科技有限公司;山东京卫制药有限公司 | CYHS2600335 | Generic | 2026/02/02 | Not stated by source | CDE |
| 济南中海医药科技有限公司;山东京卫制药有限公司 | CYHS2600334 | Generic | 2026/02/02 | Not stated by source | CDE |
| 浙江核力欣健药业有限公司;浙江赛默制药有限公司 | CYHS2502681 | Generic | 2025/07/24 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 5 filings and 4 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 湖北康正药业有限公司 | CYHS2600990 | Generic | 2026/04/28 | Not stated by source | CDE |
| 湖北华傲制药有限公司;浙江赛默制药有限公司 | CYHS2600803 | Generic | 2026/04/09 | Not stated by source | CDE |
| 武汉诺安药业有限公司 | CYHS2600576 | Generic | 2026/02/28 | Not stated by source | CDE |
| 济南中海医药科技有限公司;山东京卫制药有限公司 | CYHS2600335 | Generic | 2026/02/02 | Not stated by source | CDE |
| 济南中海医药科技有限公司;山东京卫制药有限公司 | CYHS2600334 | Generic | 2026/02/02 | Not stated by source | CDE |
API registrations
Non-component matches: 22 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| 盐酸特比萘芬 | 乐泰药业（兰西）有限公司 | Y20240000979 | A | Exact ingredient | 2026/02/13 | CDE |
| 盐酸特比萘芬 | 山东铂源药业股份有限公司 | Y20240000787 | A | Exact ingredient | 2026/06/27 | CDE |
| 盐酸特比萘芬 | M/s. Synergene Active Ingredients Pvt. Ltd. | Y20220000277 | A | Exact ingredient | 2024/08/08 | CDE |
| 盐酸特比萘芬 | Novartis Pharma AG | Y20190009965 | A | Exact ingredient | — | CDE |
| 盐酸特比萘芬 | 浙江东亚药业股份有限公司 | Y20190008903 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸特比萘芬 | 济南明鑫制药股份有限公司 | Y20190008818 | A | Exact ingredient | 2025/07/04 | CDE |
| 盐酸特比萘芬 | 山东安弘制药有限公司 | Y20190007038 | A | Exact ingredient | 2025/07/31 | CDE |
| 盐酸特比萘芬 | 重庆胜凯制药有限公司 | Y20190006898 | A | Exact ingredient | 2025/04/22 | CDE |
| 盐酸特比萘芬 | 海南凯健制药有限公司 | Y20190006812 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸特比萘芬 | 扬子江药业集团江苏海慈生物药业有限公司 | Y20190006791 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸特比萘芬 | 万特制药（海南）有限公司 | Y20190006686 | A | Exact ingredient | 2023/11/08 | CDE |
| 盐酸特比萘芬 | 悦康药业集团安徽天然制药有限公司 | Y20190006484 | A | Exact ingredient | 2026/04/08 | CDE |
| 盐酸特比萘芬 | 四川仁安药业有限责任公司 | Y20190006454 | A | Exact ingredient | — | CDE |
| 盐酸特比萘芬 | 重庆巨琪诺美制药有限公司 | Y20190006433 | A | Exact ingredient | 2025/12/16 | CDE |
| 盐酸特比萘芬 | 西南药业股份有限公司 | Y20190006304 | A | Exact ingredient | 2025/02/07 | CDE |
| 盐酸特比萘芬 | 山东铂源药业股份有限公司 | Y20190006036 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸特比萘芬 | 修正药业集团柳河制药有限公司 | Y20190005998 | A | Exact ingredient | 2025/04/02 | CDE |
| 盐酸特比萘芬 | 成都奥邦药业有限公司 | Y20190005893 | A | Exact ingredient | 2025/09/16 | CDE |
| 盐酸特比萘芬 | 浙江海正药业股份有限公司 | Y20190004323 | A | Exact ingredient | 2024/08/15 | CDE |
| 盐酸特比萘芬 | 烟台万润药业有限公司 | Y20190002484 | A | Exact ingredient | 2025/01/09 | CDE |
| 盐酸特比萘芬 | 海南通用同盟药业有限公司 | Y20190002375 | A | Exact ingredient | — | CDE |
| 盐酸特比萘芬 | 唐山金元生物制药有限公司 | Y20190001449 | A | Exact ingredient | — | CDE |
| 盐酸特比萘芬 | 广东立国制药有限公司 | Y20190001275 | A | Exact ingredient | 2023/08/16 | CDE |
| 盐酸特比萘芬 | Novartis Pharma AG | Y20170002019 | A | Exact ingredient | 2023/07/10 | 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.
-
2026/10/20Marketing application approved
四川美大康华康药业有限公司
CYHS2501633 · 国药准字H20266342
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 59 ↗
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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