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Sign in to subscribeAs of 13 November 2026, for Oxybuprocaine Hydrochloride Eye Drops, 10 applications are listed as under review at China's CDE; 8 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 3 applications
Current coverage may be incomplete
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.
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.
Loaded records: 11 distinct approval numbers and 11 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20255120 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010100548 | NHSA |
| Shenyang Xing Qi Yan Yao Co., Ltd. romanized | 国药准字H20255980 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010101322 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20263510 | 0.4%(0.5ml∶2mg) | Category B | XS01HAA203G010010104021 | NHSA |
| Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized | 国药准字H20056587 | 0.5ml:2.0mg(0.4%) | Category B | XS01HAA203G010010104072 | NHSA |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20255752 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010104693 | NHSA |
| Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized | 国药准字H20264029 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010183191 | NHSA |
| Santen Pharmaceutical Co., Ltd. | 国药准字HJ20215002 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010183504 | NHSA |
| Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | 国药准字H20249589 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010183562 | NHSA |
| Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255106 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010184160 | NHSA |
| Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264389 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010184659 | NHSA |
| Zhuhai Qian Lie Pharma Co., Ltd. romanized | 国药准字H20256449 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010185087 | NHSA |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20255120 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010200548 | NHSA |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20255752 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010204693 | NHSA |
| Santen Pharmaceutical Co., Ltd. | 国药准字HJ20215002 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010283504 | NHSA |
| Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized | 国药准字H20249589 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010283562 | NHSA |
| Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255106 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010284160 | NHSA |
| Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255106 | 0.4%(0.5ml:2mg) | Category B | XS01HAA203G010010384160 | 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.
Loaded records: 10 filings and 10 distinct first applicants.
Generic 9 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hefei Li Min Pharmaceutical Co., Ltd. romanized; You Ni Te Er Nanjing Pharmaceutical Co., Ltd. romanized | CYHS2601765 | Generic | 2026/07/22 | Not stated by source | CDE |
| Nanjing Di Chang Pharmaceuticals Technology Co., Ltd. romanized; You Ni Te Er Nanjing Pharmaceutical Co., Ltd. romanized | CYHS2503863 | Generic | 2025/11/05 | Not stated by source | CDE |
| Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized | CYHS2601626 | Generic | 2026/07/08 | Not stated by source | CDE |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized; Name not romanized | CYHS2602389 | Generic | 2026/09/23 | Not stated by source | CDE |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | CYHS2602165 | Generic | 2026/08/31 | Not stated by source | CDE |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | CYHS2602039 | Generic | 2026/08/18 | Not stated by source | CDE |
| Hunan Mai Ou Medical Technology Co., Ltd. romanized | CYHS2601198 | Generic | 2026/05/27 | Not stated by source | CDE |
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | CYHS2600945 | Generic | 2026/04/24 | Not stated by source | CDE |
| Chengdu Pusch Pharmaceutical Co., Ltd. | CYHS2600844 | Generic | 2026/04/10 | Not stated by source | CDE |
| Santen Pharmaceutical Co. Ltd.; Santen Pharmaceutical Co. Ltd. Noto Plant | JYHB2500540 | Supplement | 2025/10/17 | Not stated by source | CDE |
Loaded records: 9 filings and 8 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hefei Li Min Pharmaceutical Co., Ltd. romanized; You Ni Te Er Nanjing Pharmaceutical Co., Ltd. romanized | CYHS2601765 | Generic | 2026/07/22 | Not stated by source | CDE |
| Suzhou Le Zhu Pharmaceutical Co., Ltd. romanized | CYHS2601626 | Generic | 2026/07/08 | Not stated by source | CDE |
| Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized; Name not romanized | CYHS2602389 | Generic | 2026/09/23 | Not stated by source | CDE |
| Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized | CYHS2602165 | Generic | 2026/08/31 | Not stated by source | CDE |
| Shijiazhuang Gree Pharmaceutical Co., Ltd | CYHS2602039 | Generic | 2026/08/18 | Not stated by source | CDE |
| Hunan Mai Ou Medical Technology Co., Ltd. romanized | CYHS2601198 | Generic | 2026/05/27 | Not stated by source | CDE |
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | CYHS2600945 | Generic | 2026/04/24 | Not stated by source | CDE |
| Chengdu Pusch Pharmaceutical Co., Ltd. | CYHS2600844 | Generic | 2026/04/10 | Not stated by source | CDE |
| Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized | CYHS2600455 | Generic | 2026/02/12 | Not stated by source | CDE |
Non-component matches: 3 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 |
|---|---|---|---|---|---|---|
| 盐酸奥布卡因 · No verified English name | Shandong Chen Long Pharma Co., Ltd. romanized | Y20240001192 | A | Exact ingredient | 2026/06/17 | CDE |
| 盐酸奥布卡因 · No verified English name | Shenyang Lv Zhou Pharmaceutical Co., Ltd. romanized | Y20190007976 | A | Exact ingredient | 2025/02/28 | CDE |
| 盐酸奥布卡因 · No verified English name | Shandong Hai You Fu Rui Da Pharmaceutical Co., Ltd. romanized | Y20170002256 | A | Exact ingredient | 2026/03/18 | 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.
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.
CYHS2602389
Fact date: 2026/09/23 · Site observation date: 2026/10/22
View source ↗CYHS2602165
Fact date: 2026/08/31 · Site observation date: 2026/10/22
View source ↗CYHS2602039
Fact date: 2026/08/18 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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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