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Landiolol Hydrochloride for Injection

As of 13 November 2026, for Landiolol Hydrochloride for Injection, 19 applications are listed as under review at China's CDE; 17 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.

Companies, stages and changes, with each record available on this page.

Last 90 days: Accepted: 5 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

US Orange Book listing

The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.

Orange Book source export date: 2026/11/06. Version: 2026-11-06.

Showing 1 of 1 distinct brand names.

A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.

Verified official English dosage form: for Injection. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.

Same dosage form

No listings in this group among the displayed brand names.

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
RAPIBLYK AOP HEALTH US LLC NDA 217202 · Product no. 001 POWDER INTRAVENOUS HUMAN PRESCRIPTION DRUG 2024/11/22

Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.

Ingredient cross-list details ↗

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: 1 holders; 1 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
Nanjing Hai Chen Pharma Co., Ltd. romanizedNanjing Hai Chen Pharma Co., Ltd. romanized国药准字H202472632024/11/01150mgDrug that passed quality-and-efficacy consistency evaluationCDE
Nanjing Hai Chen Pharma Co., Ltd. romanizedNanjing Hai Chen Pharma Co., Ltd. romanized国药准字H202036692023/11/2950mgDrug that passed quality-and-efficacy consistency evaluationCDE

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: 2 distinct approval numbers and 1 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H2020366950mgCategory BXC07ABL385B001010201563NHSA
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H2020366950mgCategory BXC07ABL385B001010301563NHSA
Nanjing Hai Chen Pharma Co., Ltd. romanized国药准字H20247263150mgCategory BXC07ABL385B001020101563NHSA

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: 19 filings and 19 distinct first applicants.

Generic 18 · Supplement 1

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanizedCYHS2601435Generic2026/06/17Not stated by sourceCDE
Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanizedCYHS2602046Generic2026/08/18Not stated by sourceCDE
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanizedCYHS2602574Generic2026/10/19Not stated by sourceCDE
Hebei Yi Pin Pharmaceutical Co., Ltd. romanizedCYHS2602201Generic2026/09/03Not stated by sourceCDE
Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanizedCYHS2602049Generic2026/08/18Not stated by sourceCDE
Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCYHS2601949Generic2026/08/10Not stated by sourceCDE
Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS2601863Generic2026/08/03Not stated by sourceCDE
Zhongshan Wanhan Pharmaceuticals Co., Ltd.; Guangdong Sunho Pharmaceutical Co., Ltd.CYHS2601775Generic2026/07/24Not stated by sourceCDE
Kang Pu Pharma Co., Ltd. romanizedCYHS2601557Generic2026/07/01Not stated by sourceCDE
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS2601533Generic2026/06/30Not stated by sourceCDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS2601423Generic2026/06/16Not stated by sourceCDE
Chengdu Easton Biopharmaceuticals Co.,Ltd.CYHS2601421Generic2026/06/16Not stated by sourceCDE
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS2601362Generic2026/06/10Not stated by sourceCDE
Lang Tian Pharma (Hubei) Co., Ltd. romanizedCYHS2601314Generic2026/06/05Not stated by sourceCDE
Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanizedCYHS2601276Generic2026/06/04Not stated by sourceCDE
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS2601236Generic2026/06/01Not stated by sourceCDE
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanizedCYHS2601195Generic2026/05/26Not stated by sourceCDE
Hainan He Rui Pharmaceutical Co., Ltd. romanizedCYHS2502080Generic2025/06/12Not stated by sourceCDE
Nanjing Hai Chen Pharma Co., Ltd. romanizedCYHB2601936Supplement2026/10/22Not stated by sourceCDE
New generic filings in 2026

Loaded records: 17 filings and 17 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanizedCYHS2601435Generic2026/06/17Not stated by sourceCDE
Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanizedCYHS2602046Generic2026/08/18Not stated by sourceCDE
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanizedCYHS2602574Generic2026/10/19Not stated by sourceCDE
Hebei Yi Pin Pharmaceutical Co., Ltd. romanizedCYHS2602201Generic2026/09/03Not stated by sourceCDE
Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanizedCYHS2602049Generic2026/08/18Not stated by sourceCDE
Hainan Ling Kang Pharmaceutical Co., Ltd. romanizedCYHS2601949Generic2026/08/10Not stated by sourceCDE
Guangdong Long Fu Pharma Co., Ltd. romanizedCYHS2601863Generic2026/08/03Not stated by sourceCDE
Zhongshan Wanhan Pharmaceuticals Co., Ltd.; Guangdong Sunho Pharmaceutical Co., Ltd.CYHS2601775Generic2026/07/24Not stated by sourceCDE
Kang Pu Pharma Co., Ltd. romanizedCYHS2601557Generic2026/07/01Not stated by sourceCDE
Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanizedCYHS2601533Generic2026/06/30Not stated by sourceCDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS2601423Generic2026/06/16Not stated by sourceCDE
Chengdu Easton Biopharmaceuticals Co.,Ltd.CYHS2601421Generic2026/06/16Not stated by sourceCDE
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.CYHS2601362Generic2026/06/10Not stated by sourceCDE
Lang Tian Pharma (Hubei) Co., Ltd. romanizedCYHS2601314Generic2026/06/05Not stated by sourceCDE
Sichuan Ao Bang Gu De Pharma Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanizedCYHS2601276Generic2026/06/04Not stated by sourceCDE
Yi Chang Ren Fu Pharma Co., Ltd. romanizedCYHS2601236Generic2026/06/01Not stated by sourceCDE
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanizedCYHS2601195Generic2026/05/26Not stated by sourceCDE
API registrations

Non-component matches: 8 companies with A status and 10 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
盐酸兰地洛尔 · No verified English nameShandong Yi Kang Pharma Co., Ltd. romanizedY20260000838IExact ingredient2026/10/10CDE
盐酸兰地洛尔 · No verified English nameJiangsu Jiu Xu Pharma Co., Ltd. romanizedY20260000518IExact ingredient2026/09/14CDE
盐酸兰地洛尔 · No verified English nameHebei Yi Pin Pharmaceutical Co., Ltd. romanizedY20260000528IExact ingredient2026/06/30CDE
盐酸兰地洛尔 · No verified English nameZhejiang Guo Bang Pharma Co., Ltd. romanizedY20260000436IExact ingredient2026/06/04CDE
盐酸兰地洛尔 · No verified English nameHan Rui Pharma (Jing Men) Co., Ltd. romanizedY20250001297IExact ingredient2025/12/19CDE
盐酸兰地洛尔 · No verified English nameYi Chang Tian Rui Biopharmaceuticals Co., Ltd. romanizedY20250001011IExact ingredient2025/10/15CDE
盐酸兰地洛尔 · No verified English nameGuangdong Long Fu Pharma Co., Ltd. romanizedY20250000886IExact ingredient2025/08/25CDE
盐酸兰地洛尔 · No verified English nameKang Pu Pharma Co., Ltd. romanizedY20250000569AExact ingredient2026/10/21CDE
盐酸兰地洛尔 · No verified English nameMehta API Pvt. Ltd.Y20250000431IExact ingredient2025/07/11CDE
盐酸兰地洛尔 · No verified English nameHunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanizedY20250000441AExact ingredient2026/10/29CDE
盐酸兰地洛尔 · No verified English nameChengdu Ao Bang Pharma Co., Ltd. romanizedY20240000701AExact ingredient2026/02/25CDE
盐酸兰地洛尔 · No verified English nameZhong Rui (Nei Menggu) Pharma Co., Ltd. romanizedY20240000948IExact ingredient2025/08/06CDE
盐酸兰地洛尔 · No verified English nameZhongshan Wanhan Pharmaceuticals Co., Ltd.Y20240000889AExact ingredient2026/07/21CDE
盐酸兰地洛尔 · No verified English nameLan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedY20230001330AExact ingredient2025/07/22CDE
盐酸兰地洛尔 · No verified English nameSichuan Qing Mu Pharmaceutical Co., Ltd. romanizedY20230001029AExact ingredient2025/11/21CDE
盐酸兰地洛尔 · No verified English nameHainan He Rui Pharmaceutical Co., Ltd. romanizedY20230000570AExact ingredient2025/02/14CDE
盐酸兰地洛尔 · No verified English namePROCOS S.P.AY20220000150IExact ingredient2024/07/23CDE
盐酸兰地洛尔 · No verified English nameNanjing Hai Chen Pharma Co., Ltd. romanizedY20170001289AExact ingredient2025/05/21CDE

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.

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. 2026/10/22Accepted

    Nanjing Hai Chen Pharma Co., Ltd. romanized

    CYHB2601936

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

    View source ↗
  2. 2026/10/19Accepted

    Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized

    CYHS2602574

    Fact date: 2026/10/19 · Site observation date: 2026/10/22

    View source ↗
  3. 2026/09/03Accepted

    Hebei Yi Pin Pharmaceutical Co., Ltd. romanized

    CYHS2602201

    Fact date: 2026/09/03 · Site observation date: 2026/10/22

    View source ↗
  4. 2026/08/18Accepted

    Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized

    CYHS2602049

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

    View source ↗
  5. 2026/08/18Accepted

    Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized

    CYHS2602046

    Fact date: 2026/08/18 · 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.

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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