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Ambroxol Hydrochloride Solution For Inhalation

As of 13 November 2026, for Ambroxol Hydrochloride Solution For Inhalation, 10 applications are listed as under review at China's CDE; 3 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: 4 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 8 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Hanmi Pharm. Co., Ltd.国药准字HJ201910182ml:15mgCategory BXR05CBA198L019010100041NHSA
Yin Gu Pharmaceutical Co., Ltd. romanized国药准字H202230502ml:15mgCategory BXR05CBA198L019010100123NHSA
Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized国药准字H202232802ml:15mgCategory BXR05CBA198L019010102829NHSA
Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized国药准字H202036682ml:15mgCategory BXR05CBA198L019010106286NHSA
Beijing Han Mei Medicines Co., Ltd. romanized国药准字H202661441ml:7.5mgCategory BXR05CBA198L019010183184NHSA
Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized国药准字H202544242ml:15mgCategory BXR05CBA198L019010183547NHSA
Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized国药准字H202542102ml:15mgCategory BXR05CBA198L019010183719NHSA
Shandong Hui Cheng Pharmaceutical Co., Ltd. romanized国药准字H202534653ml:22.5mgCategory BXR05CBA198L019010183905NHSA
Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized国药准字H202232802ml:15mgCategory BXR05CBA198L019010202829NHSA
Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized国药准字H202036682ml:15mgCategory BXR05CBA198L019010206286NHSA
Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized国药准字H202544242ml:15mgCategory BXR05CBA198L019010283547NHSA
Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized国药准字H202542102ml:15mgCategory BXR05CBA198L019010283719NHSA
Shandong Hui Cheng Pharmaceutical Co., Ltd. romanized国药准字H202534653ml:22.5mgCategory BXR05CBA198L019010283905NHSA
Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized国药准字H202036682ml:15mgCategory BXR05CBA198L019010306286NHSA
Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized国药准字H202544242ml:15mgCategory BXR05CBA198L019010383547NHSA
Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized国药准字H202036682ml:15mgCategory BXR05CBA198L019010406286NHSA
Hanmi Pharm. Co., Ltd.国药准字HJ201910182ml:15mgCategory BXR05CBA198L019020100041NHSA
Yin Gu Pharmaceutical Co., Ltd. romanized国药准字H202230502ml:15mgCategory BXR05CBA198L019020100123NHSA
Hanmi Pharm.Co.,Ltd.国药准字HJ201900412ml:15mgCategory BXR05CBA198L019020179031NHSA
Beijing Han Mei Medicines Co., Ltd. romanized国药准字H202661452ml:15mgCategory BXR05CBA198L019020183184NHSA
Shandong Hui Cheng Pharmaceutical Co., Ltd. romanized国药准字H202534662ml:15mgCategory BXR05CBA198L019020183905NHSA
Hanmi Pharm.Co.,Ltd.国药准字HJ201900412ml:15mgCategory BXR05CBA198L019020279031NHSA
Hanmi Pharm.Co.,Ltd.国药准字HJ201900412ml:15mgCategory BXR05CBA198L019020379031NHSA

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 6 distinct first applicants.

Generic 5 · Supplement 5

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Hua Gai Pharmaceutical Co., Ltd. romanizedCYHS2601788Generic2026/07/27Not stated by sourceCDE
Sichuan Pu Rui Te Pharma Co., Ltd. romanizedCYHS2601901Generic2026/08/05Not stated by sourceCDE
Sichuan Pu Rui Te Pharma Co., Ltd. romanizedCYHS2601900Generic2026/08/05Not stated by sourceCDE
Sichuan Pu Rui Te Pharma Co., Ltd. romanizedCYHS2601899Generic2026/08/05Not stated by sourceCDE
Sichuan Zhi Qiang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Chengdu Ping Yuan Pharma Co., Ltd. romanizedCYHS2601774Generic2026/07/23Not stated by sourceCDE
Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanizedCYHB2600550Supplement2026/03/20Not stated by sourceCDE
Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanizedCYHB2601968Supplement2026/10/27Not stated by sourceCDE
Shanxi Yang He Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu Heng Pharmaceutical Co., Ltd. romanizedCYHB2601967Supplement2026/10/27Not stated by sourceCDE
Shandong Hui Cheng Pharmaceutical Co., Ltd. romanized; Rui Yang Pharmaceutical Co., Ltd. romanizedCYHB2601974Supplement2026/10/28Not stated by sourceCDE
Shandong Hui Cheng Pharmaceutical Co., Ltd. romanized; Rui Yang Pharmaceutical Co., Ltd. romanizedCYHB2601973Supplement2026/10/28Not stated by sourceCDE
New generic filings in 2026

Loaded records: 8 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Hua Gai Pharmaceutical Co., Ltd. romanizedCYHS2601788Generic2026/07/27Not stated by sourceCDE
Sichuan Pu Rui Te Pharma Co., Ltd. romanizedCYHS2601901Generic2026/08/05Not stated by sourceCDE
Sichuan Pu Rui Te Pharma Co., Ltd. romanizedCYHS2601900Generic2026/08/05Not stated by sourceCDE
Sichuan Pu Rui Te Pharma Co., Ltd. romanizedCYHS2601899Generic2026/08/05Not stated by sourceCDE
Sichuan Zhi Qiang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Chengdu Ping Yuan Pharma Co., Ltd. romanizedCYHS2601774Generic2026/07/23Not stated by sourceCDE
Sichuan Pu Rui Te Pharma Co., Ltd. romanizedCYHL2600048Generic2026/04/13Not stated by sourceCDE
Sichuan Pu Rui Te Pharma Co., Ltd. romanizedCYHL2600047Generic2026/04/13Not stated by sourceCDE
Sichuan Pu Rui Te Pharma Co., Ltd. romanizedCYHL2600046Generic2026/04/13Not stated by sourceCDE
API registrations

Non-component matches: 0 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
No matching records were found in the currently loaded source data; coverage dates are listed below.

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. 2026/10/28Accepted

    Shandong Hui Cheng Pharmaceutical Co., Ltd. romanized; Rui Yang Pharmaceutical Co., Ltd. romanized

    CYHB2601974

    Fact date: 2026/10/28 · Site observation date: 2026/10/29

    View source ↗
  2. 2026/10/28Accepted

    Shandong Hui Cheng Pharmaceutical Co., Ltd. romanized; Rui Yang Pharmaceutical Co., Ltd. romanized

    CYHB2601973

    Fact date: 2026/10/28 · Site observation date: 2026/10/29

    View source ↗
  3. 2026/10/27Accepted
  4. 2026/10/27Accepted

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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