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Public drug landscapesDrug landscape

Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II)

As of 13 November 2026, for Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II), 5 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 25 holders.

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

Last 90 days: No longer listed under review: 2 applicationsSupplement delivery: 2 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: 25 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 24 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanizedXin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized国药准字H202644182026/05/19See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanizedHubei Wu Shi Pharma Co., Ltd. romanized国药准字H202639852026/04/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanizedShijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized国药准字H202640032026/04/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Gan Li Pharma Shandong Co., Ltd. romanizedGan Li Pharma Shandong Co., Ltd. romanized国药准字H202637652026/03/31See sourceGeneric approved under the new chemical-drug registration classificationCDE
Beijing SL Pharmaceutical Co., Ltd.Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized国药准字H202636922026/03/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hunan Wei Te Pharmaceutical Co., Ltd. romanizedHunan Wei Te Pharmaceutical Co., Ltd. romanized国药准字H202557972025/10/28See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Yong Tai Pharma Co., Ltd. romanizedZhejiang Yong Tai Pharma Co., Ltd. romanized国药准字H202531992025/01/14See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Kang Yuan Pharma Co., Ltd. romanizedJiangsu Kang Yuan Pharma Co., Ltd. romanized国药准字H202530742025/01/08See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanizedZhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized国药准字H202495362024/12/01See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Nord Pharmaceutical Co., LtdZhejiang Nord Pharmaceutical Co., Ltd国药准字H202448992024/09/19See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jilin Chang Bai Shan Pharma Group Co., Ltd. romanizedJilin Chang Bai Shan Pharma Group Co., Ltd. romanized国药准字H202447802024/09/03See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202441592024/06/25See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hui Sheng Biopharmaceutical Co., Ltd. romanizedTianjin Han Rui Pharma Co., Ltd. romanized国药准字H202438022024/05/21See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Deyuan Pharmaceutical Co.,Ltd.Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H202437102024/05/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H202437122024/05/15See sourceGeneric approved under the new chemical-drug registration classificationCDE
Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanizedCISEN PHARMACEUTICAL CO., LTD.国药准字H202435682024/04/24See sourceGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanizedShandong Lang Nuo Pharmaceutical Co., Ltd. romanized国药准字H202434002024/03/29See sourceGeneric approved under the new chemical-drug registration classificationCDE
Qilu Pharmaceutical (Hainan) Co., LtdQilu Pharmaceutical (Hainan) Co., Ltd国药准字H202338042023/06/27See sourceGeneric approved under the new chemical-drug registration classificationCDE
Shenzhen Han Yu Pharma Co., Ltd. romanizedShenzhen Han Yu Pharma Co., Ltd. romanized国药准字H202330252023/01/10See sourceGeneric approved under the new chemical-drug registration classificationCDE
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H202238732022/11/22See sourceGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanizedHangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized国药准字H202271372022/10/21See sourceGeneric approved under the new chemical-drug registration classificationCDE
Tong Hua Dong Bao Pharma Co., Ltd. romanizedTong Hua Dong Bao Pharma Co., Ltd. romanized国药准字H202137902021/10/19See sourceGeneric approved under the new chemical-drug registration classificationCDE
Guangdong Dong Yang Guang Pharma Co., Ltd. romanizedGuangdong Dong Yang Guang Pharma Co., Ltd. romanized国药准字H202034402020/08/17See sourceGeneric approved under the new chemical-drug registration classificationCDE
MSD Pharma (Singapore) Pte.LtdPatheon Puerto Rico, Inc. (Manati)H201407752012/07/23See sourceImported originator drugCDE
Beijing Yuan Yan Pharmaceuticals Technology Co., Ltd. romanizedQingdao Huang Hai Pharmaceutical Co., Ltd. romanized国药准字H202659902026/09/15See 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: 25 distinct approval numbers and 25 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing SL Pharmaceutical Co., Ltd.国药准字H20263692See sourceCategory BXA10BDX223A001010100148NHSA
Jiangsu Kang Yuan Pharma Co., Ltd. romanized国药准字H20253074See sourceCategory BXA10BDX223A001010101463NHSA
MSD Merck Sharp & Dohme AG国药准字HJ20140775See sourceCategory BXA10BDX223A001010104495NHSA
Hui Sheng Biopharmaceutical Co., Ltd. romanized国药准字H20243802See sourceCategory BXA10BDX223A001010182963NHSA
MSD Merck Sharp & Dohme AG国药准字HJ20140775See sourceCategory BXA10BDX223A001010204495NHSA
Hui Sheng Biopharmaceutical Co., Ltd. romanized国药准字H20243802See sourceCategory BXA10BDX223A001010282963NHSA
Hui Sheng Biopharmaceutical Co., Ltd. romanized国药准字H20243802See sourceCategory BXA10BDX223A001010382963NHSA
Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized国药准字H20264003See sourceCategory BXA10BDX223A001010102753NHSA
Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized国药准字H20263985See sourceCategory BXA10BDX223A001010184568NHSA
Gan Li Pharma Shandong Co., Ltd. romanized国药准字H20263765See sourceCategory BXA10BDX223A001010185033NHSA
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized国药准字H20264418See sourceCategory BXA10BDX223A001010185553NHSA
Gan Li Pharma Shandong Co., Ltd. romanized国药准字H20263765See sourceCategory BXA10BDX223A001010285033NHSA
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized国药准字H20264418See sourceCategory BXA10BDX223A001020185553NHSA
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized国药准字H20264418See sourceCategory BXA10BDX223A001030185553NHSA
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized国药准字H20264418See sourceCategory BXA10BDX223A001040185553NHSA
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized国药准字H20264418See sourceCategory BXA10BDX223A001050185553NHSA
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized国药准字H20264418See sourceCategory BXA10BDX223A001060185553NHSA
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized国药准字H20264418See sourceCategory BXA10BDX223A001070185553NHSA
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized国药准字H20264418See sourceCategory BXA10BDX223A001080185553NHSA
Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized国药准字H20264418See sourceCategory BXA10BDX223A001090185553NHSA
Jilin Chang Bai Shan Pharma Group Co., Ltd. romanized国药准字H20244780See sourceCategory BXA10BDX223A001010103364NHSA
Tong Hua Dong Bao Pharma Co., Ltd. romanized国药准字H20213790See sourceCategory BXA10BDX223A001010103546NHSA
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized国药准字H20227137See sourceCategory BXA10BDX223A001010104520NHSA
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H20243712See sourceCategory BXA10BDX223A001010104565NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20223873See sourceCategory BXA10BDX223A001010104647NHSA
Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized国药准字H20249536See sourceCategory BXA10BDX223A001010104749NHSA
Nanchang Li Jian Pharma Co., Ltd. romanized国药准字H20255970See sourceCategory BXA10BDX223A001010105405NHSA
Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H20233804See sourceCategory BXA10BDX223A001010105847NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H20243710See sourceCategory BXA10BDX223A001010106632NHSA
Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized国药准字H20203440See sourceCategory BXA10BDX223A001010106988NHSA
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H20233025See sourceCategory BXA10BDX223A001010179260NHSA
MSD Pharma(Singapore) Pte. LtdH20140775See sourceCategory BXA10BDX223A001010179533NHSA
Zhejiang Yong Tai Pharma Co., Ltd. romanized国药准字H20253199See sourceCategory BXA10BDX223A001010181012NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001010183521NHSA
Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized国药准字H20243400See sourceCategory BXA10BDX223A001010184212NHSA
Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized国药准字H20244159See sourceCategory BXA10BDX223A001010184227NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001010184415NHSA
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized国药准字H20227137See sourceCategory BXA10BDX223A001010204520NHSA
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.国药准字H20243712See sourceCategory BXA10BDX223A001010204565NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20223873See sourceCategory BXA10BDX223A001010204647NHSA
Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized国药准字H20233804See sourceCategory BXA10BDX223A001010205847NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H20243710See sourceCategory BXA10BDX223A001010206632NHSA
Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized国药准字H20203440See sourceCategory BXA10BDX223A001010206988NHSA
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H20233025See sourceCategory BXA10BDX223A001010279260NHSA
MSD Pharma(Singapore) Pte. LtdH20140775See sourceCategory BXA10BDX223A001010279533NHSA
Zhejiang Yong Tai Pharma Co., Ltd. romanized国药准字H20253199See sourceCategory BXA10BDX223A001010281012NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001010283521NHSA
Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized国药准字H20243400See sourceCategory BXA10BDX223A001010284212NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001010284415NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20223873See sourceCategory BXA10BDX223A001010304647NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H20243710See sourceCategory BXA10BDX223A001010306632NHSA
Shenzhen Han Yu Pharma Co., Ltd. romanized国药准字H20233025See sourceCategory BXA10BDX223A001010379260NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001010383521NHSA
Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized国药准字H20243400See sourceCategory BXA10BDX223A001010384212NHSA
Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized国药准字H20244159See sourceCategory BXA10BDX223A001010384227NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001010384415NHSA
ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.国药准字H20223873See sourceCategory BXA10BDX223A001010404647NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H20243710See sourceCategory BXA10BDX223A001010406632NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001010483521NHSA
Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized国药准字H20244159See sourceCategory BXA10BDX223A001010484227NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001010484415NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H20243710See sourceCategory BXA10BDX223A001010506632NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001010583521NHSA
Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized国药准字H20244159See sourceCategory BXA10BDX223A001010584227NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001010584415NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H20243710See sourceCategory BXA10BDX223A001010606632NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001010683521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001010684415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001010783521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001010784415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001010883521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001010884415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001010983521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001010984415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001011083521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001011084415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001011183521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001011184415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001011283521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001011284415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001011383521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001011384415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001011483521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001011484415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001011583521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001011584415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001011683521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001011684415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001011783521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001011784415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001011883521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001011884415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001011983521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001011984415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001012083521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001012084415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001012183521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001012184415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001012283521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001012284415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001012383521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001012384415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001012483521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001012484415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001012583521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001012584415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001012683521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001012684415NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H20244899See sourceCategory BXA10BDX223A001012783521NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001012784415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001012884415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001012984415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001013084415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001013184415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001013284415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001013384415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001013484415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001013584415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001013684415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001013784415NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H20243568See sourceCategory BXA10BDX223A001013884415NHSA

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: 5 filings and 5 distinct first applicants.

Generic 5

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Duo Duo Pharma Co., Ltd. romanizedCYHS2503626Generic2025/10/11Not stated by sourceCDE
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedCYHS2201824Generic2022/10/25Not stated by sourceCDE
Shandong Pu Rui Man Pharma Co., Ltd. romanizedCYHS2601859Generic2026/08/03Not stated by sourceCDE
Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanizedCYHS2601246Generic2026/06/02Not stated by sourceCDE
Jiangxi Shimei Pharmaceutical Co., LtdCYHS2501932Generic2025/05/30Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Shandong Pu Rui Man Pharma Co., Ltd. romanizedCYHS2601859Generic2026/08/03Not stated by sourceCDE
Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanizedCYHS2601246Generic2026/06/02Not 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. 2026/10/23No longer listed under review

    MSD Merck Sharp & Dohme AG; MSD International GmbH (Singapore Branch)

    JYHB2600395

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

    Accepted: 2026/07/17

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  2. 2026/10/23No longer listed under review

    MSD Merck Sharp & Dohme AG; MSD International GmbH (Singapore Branch)

    JYHB2600394

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

    Accepted: 2026/07/17

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  3. 2026/10/21Supplement delivery

    Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized

    JYHB2600395

    Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 167 ↗
  4. 2026/10/21Supplement delivery

    Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized

    JYHB2600394

    Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03

    Supplemental application; excluded from new marketing approvals.

    View source · Table row 166 ↗

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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