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Teneligliptin Hydrobromide Hydrate Tablets

As of 13 November 2026, for Teneligliptin Hydrobromide Hydrate Tablets, 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 4 holders.

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

No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/13 06:42

Current coverage may be incomplete

Follow for free
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: 4 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 4 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanizedSuzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized国药准字H202644132026/05/19See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Xing Yue Drug Technology Co., Ltd. romanizedTianjin Han Rui Pharma Co., Ltd. romanized国药准字H202549022025/07/22See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Xing Yue Drug Technology Co., Ltd. romanizedTianjin Han Rui Pharma Co., Ltd. romanized国药准字H202549032025/07/22See sourceGeneric approved under the new chemical-drug registration classificationCDE
Sichuan Kelun Pharmaceutical Co., Ltd.Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H202335782023/05/19See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Nord Pharmaceutical Co., LtdZhejiang Nord Pharmaceutical Co., Ltd国药准字H202661992026/10/13See sourceGeneric approved under the new chemical-drug registration classificationCDE

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: 6 distinct approval numbers and 5 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized国药准字H20264413See sourceCategory BXA10BHT196A001010101679NHSA
Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized国药准字H20264413See sourceCategory BXA10BHT196A001010201679NHSA
Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized国药准字H20264413See sourceCategory BXA10BHT196A001010301679NHSA
Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized国药准字H20264413See sourceCategory BXA10BHT196A001010401679NHSA
Sichuan Kelun Pharmaceutical Co., Ltd.国药准字H20233578See sourceCategory BXA10BHT196A001010102180NHSA
Mitsubishi Tanabe Pharma Corporation国药准字HJ20210064See sourceCategory BXA10BHT196A001010179327NHSA
Zhejiang Xing Yue Drug Technology Co., Ltd. romanized国药准字H20254903See sourceCategory BXA10BHT196A001010183886NHSA
Zhejiang Xing Yue Drug Technology Co., Ltd. romanized国药准字H20254902See sourceCategory BXA10BHT196A001020183886NHSA
Zhejiang Xing Yue Drug Technology Co., Ltd. romanized国药准字H20254902See sourceCategory BXA10BHT196A001020283886NHSA
Zhejiang Xing Yue Drug Technology Co., Ltd. romanized国药准字H20254902See sourceCategory BXA10BHT196A001020383886NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001010183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001010283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001010383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001010483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001010583521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001010683521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001010783521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001010883521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001010983521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001011083521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001011183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001011283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001011383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001011483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001011583521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001011683521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001011783521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001011883521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001011983521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001012083521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001012183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001012283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001012383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001012483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001012583521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001012683521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001012783521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001012883521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001012983521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001013083521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001013183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001013283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001013383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001013483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001013583521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001013683521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001013783521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001013883521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001013983521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001014083521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001014183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001014283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001014383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20266199See sourceCategory BXA10BHT196A001014483521NHSA

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 9 distinct first applicants.

Generic 10

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanizedCYHS2600312Generic2026/01/30Not stated by sourceCDE
Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedCYHS2504230Generic2025/12/10Not stated by sourceCDE
Jiangsu Qian Ren Bio Technology Co., Ltd. romanizedCYHS2502313Generic2025/06/28Not stated by sourceCDE
Changzhou Qian Hong Sheng Hua Pharmaceutical Co., Ltd. romanizedCYHS2503847Generic2025/10/31Not stated by sourceCDE
Yuan Da Pharmaceuticals (Tianjin) Co., Ltd. romanizedCYHS2601342Generic2026/06/08Not stated by sourceCDE
Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanizedCYHS2600669Generic2026/03/17Not stated by sourceCDE
Jiangxi Shimei Pharmaceutical Co., LtdCYHS2504135Generic2025/12/02Not stated by sourceCDE
Jiangxi Shimei Pharmaceutical Co., LtdCYHS2504134Generic2025/12/02Not stated by sourceCDE
Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized; Zhejiang Hao Ge Pharma Co., Ltd. romanizedCYHS2503636Generic2025/10/12Not stated by sourceCDE
Guangzhou Hui Yuan Pharmaceuticals Technology Co., Ltd. romanized; Zhong Shan Ke Ke Kang Pharmaceutical Co., Ltd. romanizedCYHS2503575Generic2025/09/29Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanizedCYHS2600312Generic2026/01/30Not stated by sourceCDE
Yuan Da Pharmaceuticals (Tianjin) Co., Ltd. romanizedCYHS2601342Generic2026/06/08Not stated by sourceCDE
Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Jilin Tian Heng Ying Rui Pharmaceutical Co., Ltd. romanizedCYHS2600669Generic2026/03/17Not stated by sourceCDE
API registrations

Non-component matches: 4 companies with A status and 2 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
氢溴酸替格列汀 · No verified English nameJiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedY20250001275IExact ingredient2025/11/28CDE
氢溴酸替格列汀 · No verified English nameAMI LIFESCIENCES PVT. LTD.Y20250000428IExact ingredient2025/05/21CDE
氢溴酸替格列汀 · No verified English nameShandong Long Chen Pharma Co., Ltd. romanizedY20240000624AExact ingredient2026/03/06CDE
氢溴酸替格列汀 · No verified English nameZhejiang Xing Yue Drug Technology Co., Ltd. romanizedY20230000497AExact ingredient2026/05/20CDE
氢溴酸替格列汀 · No verified English nameMetrochem API Private LimitedY20220000579AExact ingredient2026/06/18CDE
氢溴酸替格列汀 · No verified English nameSichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanizedY20190000608AExact ingredient2026/06/16CDE

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. No matching records were found in the currently loaded source data; coverage dates are listed below.

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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