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As of 13 November 2026, for Flomoxef Sodium for Injection, 9 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 6 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 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.
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.
Catalogue holders6View records ↓
Under-review filings9View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers5View records ↓
API companies with A status6View records ↓
Chemical-drug catalogue
Loaded records: 6 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 6 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 |
|---|---|---|---|---|---|---|
| Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | 国药准字H20266215 | 2026/10/13 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | 国药准字H20266216 | 2026/10/13 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hai Tao Xin Yao Research and Development (Jiangsu) Co., Ltd. romanized | Zhejiang Hui Di Sen Pharma Co., Ltd. romanized | 国药准字H20266124 | 2026/09/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | Zhejiang Hui Di Sen Pharma Co., Ltd. romanized | 国药准字H20265525 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Hui Di Sen Pharma Co., Ltd. romanized | Zhejiang Hui Di Sen Pharma Co., Ltd. romanized | 国药准字H20255124 | 2025/08/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Po Nuo (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized | Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized | 国药准字H20253864 | 2025/04/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized | Zhejiang Hui Di Sen Pharma Co., Ltd. romanized | 国药准字H20265507 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | 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: 5 distinct approval numbers and 5 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20265525 | See source | Not stated by source | XJ01DCF099B001010102297 | NHSA |
| Zhejiang Hui Di Sen Pharma Co., Ltd. romanized | 国药准字H20255124 | See source | Not stated by source | XJ01DCF099B001010104651 | NHSA |
| Shionogi & Co., Ltd. | 国药准字HJ20150081 | See source | Not stated by source | XJ01DCF099B001010179170 | NHSA |
| Po Nuo (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized | 国药准字H20253864 | See source | Not stated by source | XJ01DCF099B001010184606 | NHSA |
| Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized | 国药准字H20265507 | See source | Not stated by source | XJ01DCF099B001010184971 | NHSA |
| Zhejiang Hui Di Sen Pharma Co., Ltd. romanized | 国药准字H20255124 | See source | Not stated by source | XJ01DCF099B001010204651 | NHSA |
| Po Nuo (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized | 国药准字H20253864 | See source | Not stated by source | XJ01DCF099B001010284606 | NHSA |
| Shionogi & Co., Ltd. | 国药准字HJ20150081 | See source | Not stated by source | XJ01DCF099B001020179170 | 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: 9 filings and 6 distinct first applicants.
Generic 9
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Yunnan Xian Shi Pharma Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CYHS2602520 | Generic | 2026/10/13 | Not stated by source | CDE |
| Yunnan Xian Shi Pharma Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CYHS2602519 | Generic | 2026/10/13 | Not stated by source | CDE |
| Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CYHS2502068 | Generic | 2025/06/11 | Not stated by source | CDE |
| Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CYHS2502067 | Generic | 2025/06/11 | Not stated by source | CDE |
| Suzhou Erye Pharmaceutical Co., Ltd; Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized | CYHS2503437 | Generic | 2025/09/17 | Not stated by source | CDE |
| Suzhou Erye Pharmaceutical Co., Ltd; Chongqing Ji Si Rui Pharmaceutical Co., Ltd. romanized | CYHS2503436 | Generic | 2025/09/17 | Not stated by source | CDE |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2601017 | Generic | 2026/04/30 | Not stated by source | CDE |
| Hainan Brilliant Pharmaceutical Co., Ltd. | CYHS2504120 | Generic | 2025/12/02 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2502635 | Generic | 2025/07/22 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Yunnan Xian Shi Pharma Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CYHS2602520 | Generic | 2026/10/13 | Not stated by source | CDE |
| Yunnan Xian Shi Pharma Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized | CYHS2602519 | Generic | 2026/10/13 | Not stated by source | CDE |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2601017 | Generic | 2026/04/30 | Not stated by source | CDE |
API registrations
Non-component matches: 6 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 |
|---|---|---|---|---|---|---|
| 氟氧头孢钠 · No verified English name | Fu An Pharma Group Chongqing Bo Sheng Pharmaceutical Co., Ltd. romanized | Y20250000246 | A | Exact ingredient | 2026/10/21 | CDE |
| 氟氧头孢钠 · No verified English name | Qi Lu An Ti Pharmaceutical Co., Ltd. romanized | Y20240000902 | A | Exact ingredient | 2026/01/15 | CDE |
| 氟氧头孢钠 · No verified English name | Fujian Sheng Fu Kang Pharma Co., Ltd. romanized | Y20240000661 | A | Exact ingredient | 2026/01/16 | CDE |
| 氟氧头孢钠 · No verified English name | Shanxi Qian Xiu Pharmaceutical Co., Ltd. romanized | Y20230001322 | A | Exact ingredient | 2025/06/24 | CDE |
| 氟氧头孢钠 · No verified English name | Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized | Y20220000909 | I | Exact ingredient | 2022/11/08 | CDE |
| 氟氧头孢钠 · No verified English name | Jeil Pharmaceutical Co., Ltd | Y20220000517 | A | Exact ingredient | 2025/08/09 | CDE |
| 氟氧头孢钠 · No verified English name | Zhejiang Xin He Cheng Co., Ltd. romanized | Y20170001108 | A | Exact ingredient | 2023/03/24 | 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/11/03Marketing application approved
Fujian Sheng Fu Kang Pharma Co., Ltd. romanized
CYHS2501518 · 国药准字H20266464
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
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 55 ↗ -
2026/10/13Accepted
Yunnan Xian Shi Pharma Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized
CYHS2602520
Fact date: 2026/10/13 · Site observation date: 2026/10/21
View source ↗ -
2026/10/13Accepted
Yunnan Xian Shi Pharma Co., Ltd. romanized; Shandong Lu Kang San Ye Pharmaceutical Co., Ltd. romanized
CYHS2602519
Fact date: 2026/10/13 · Site observation date: 2026/10/21
View source ↗
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
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: 2026/11/13 06:41
- 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: 2026/11/12 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.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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