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Oxybuprocaine Hydrochloride Eye Drops

As 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

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Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

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.

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue 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: 11 distinct approval numbers and 11 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized国药准字H202551200.4%(0.5ml:2mg)Category BXS01HAA203G010010100548NHSA
Shenyang Xing Qi Yan Yao Co., Ltd. romanized国药准字H202559800.4%(0.5ml:2mg)Category BXS01HAA203G010010101322NHSA
Qilu Pharmaceutical Co., Ltd.国药准字H202635100.4%(0.5ml∶2mg)Category BXS01HAA203G010010104021NHSA
Shandong Bo Shi Lun Fu Rui Da Pharmaceutical Co., Ltd. romanized国药准字H200565870.5ml:2.0mg(0.4%)Category BXS01HAA203G010010104072NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H202557520.4%(0.5ml:2mg)Category BXS01HAA203G010010104693NHSA
Shandong Chen Xin Fu Dou Pharma Co., Ltd. romanized国药准字H202640290.4%(0.5ml:2mg)Category BXS01HAA203G010010183191NHSA
Santen Pharmaceutical Co., Ltd.国药准字HJ202150020.4%(0.5ml:2mg)Category BXS01HAA203G010010183504NHSA
Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized国药准字H202495890.4%(0.5ml:2mg)Category BXS01HAA203G010010183562NHSA
Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized国药准字H202551060.4%(0.5ml:2mg)Category BXS01HAA203G010010184160NHSA
Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized国药准字H202643890.4%(0.5ml:2mg)Category BXS01HAA203G010010184659NHSA
Zhuhai Qian Lie Pharma Co., Ltd. romanized国药准字H202564490.4%(0.5ml:2mg)Category BXS01HAA203G010010185087NHSA
Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized国药准字H202551200.4%(0.5ml:2mg)Category BXS01HAA203G010010200548NHSA
Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized国药准字H202557520.4%(0.5ml:2mg)Category BXS01HAA203G010010204693NHSA
Santen Pharmaceutical Co., Ltd.国药准字HJ202150020.4%(0.5ml:2mg)Category BXS01HAA203G010010283504NHSA
Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized国药准字H202495890.4%(0.5ml:2mg)Category BXS01HAA203G010010283562NHSA
Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized国药准字H202551060.4%(0.5ml:2mg)Category BXS01HAA203G010010284160NHSA
Zhejiang Shi Fang Ji Pharmaceuticals Technology Co., Ltd. romanized国药准字H202551060.4%(0.5ml:2mg)Category BXS01HAA203G010010384160NHSA

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 10 distinct first applicants.

Generic 9 · Supplement 1

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hefei Li Min Pharmaceutical Co., Ltd. romanized; You Ni Te Er Nanjing Pharmaceutical Co., Ltd. romanizedCYHS2601765Generic2026/07/22Not stated by sourceCDE
Nanjing Di Chang Pharmaceuticals Technology Co., Ltd. romanized; You Ni Te Er Nanjing Pharmaceutical Co., Ltd. romanizedCYHS2503863Generic2025/11/05Not stated by sourceCDE
Suzhou Le Zhu Pharmaceutical Co., Ltd. romanizedCYHS2601626Generic2026/07/08Not stated by sourceCDE
Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized; Name not romanizedCYHS2602389Generic2026/09/23Not stated by sourceCDE
Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanizedCYHS2602165Generic2026/08/31Not stated by sourceCDE
Shijiazhuang Gree Pharmaceutical Co., LtdCYHS2602039Generic2026/08/18Not stated by sourceCDE
Hunan Mai Ou Medical Technology Co., Ltd. romanizedCYHS2601198Generic2026/05/27Not stated by sourceCDE
Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanizedCYHS2600945Generic2026/04/24Not stated by sourceCDE
Chengdu Pusch Pharmaceutical Co., Ltd.CYHS2600844Generic2026/04/10Not stated by sourceCDE
Santen Pharmaceutical Co. Ltd.; Santen Pharmaceutical Co. Ltd. Noto PlantJYHB2500540Supplement2025/10/17Not stated by sourceCDE
New generic filings in 2026

Loaded records: 9 filings and 8 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hefei Li Min Pharmaceutical Co., Ltd. romanized; You Ni Te Er Nanjing Pharmaceutical Co., Ltd. romanizedCYHS2601765Generic2026/07/22Not stated by sourceCDE
Suzhou Le Zhu Pharmaceutical Co., Ltd. romanizedCYHS2601626Generic2026/07/08Not stated by sourceCDE
Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized; Name not romanizedCYHS2602389Generic2026/09/23Not stated by sourceCDE
Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanizedCYHS2602165Generic2026/08/31Not stated by sourceCDE
Shijiazhuang Gree Pharmaceutical Co., LtdCYHS2602039Generic2026/08/18Not stated by sourceCDE
Hunan Mai Ou Medical Technology Co., Ltd. romanizedCYHS2601198Generic2026/05/27Not stated by sourceCDE
Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanizedCYHS2600945Generic2026/04/24Not stated by sourceCDE
Chengdu Pusch Pharmaceutical Co., Ltd.CYHS2600844Generic2026/04/10Not stated by sourceCDE
Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanizedCYHS2600455Generic2026/02/12Not stated by sourceCDE
API registrations

Non-component matches: 3 companies with A status and 0 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸奥布卡因 · No verified English nameShandong Chen Long Pharma Co., Ltd. romanizedY20240001192AExact ingredient2026/06/17CDE
盐酸奥布卡因 · No verified English nameShenyang Lv Zhou Pharmaceutical Co., Ltd. romanizedY20190007976AExact ingredient2025/02/28CDE
盐酸奥布卡因 · No verified English nameShandong Hai You Fu Rui Da Pharmaceutical Co., Ltd. romanizedY20170002256AExact ingredient2026/03/18CDE

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.

  1. 2026/09/23Accepted

    Beijing Hui En Lan De Pharmaceutical Co., Ltd. romanized; Name not romanized

    CYHS2602389

    Fact date: 2026/09/23 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/08/31Accepted

    Shanghai A Er Fu Si Pharmaceuticals Technology Co., Ltd. romanized

    CYHS2602165

    Fact date: 2026/08/31 · Site observation date: 2026/10/22

    View source ↗
  3. 2026/08/18Accepted

    Shijiazhuang Gree Pharmaceutical Co., Ltd

    CYHS2602039

    Fact date: 2026/08/18 · Site observation date: 2026/10/22

    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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