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Alfacalcidol Soft Capsules

As of 13 November 2026, for Alfacalcidol Soft Capsules, 9 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 12 holders.

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

Last 90 days: Accepted: 3 applications

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: 12 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 6 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Nanjing Hai Jing Pharma Co., Ltd. romanizedNanjing Hai Jing Pharma Co., Ltd. romanized国药准字H202645572026/05/270.5μgGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Hai Jing Pharma Co., Ltd. romanizedNanjing Hai Jing Pharma Co., Ltd. romanized国药准字H202645562026/05/271μgGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Hai Jing Pharma Co., Ltd. romanizedNanjing Hai Jing Pharma Co., Ltd. romanized国药准字H202645582026/05/270.25μgGeneric approved under the new chemical-drug registration classificationCDE
Nan Tong Hua Shan Pharma Co., Ltd. romanizedNan Tong Hua Shan Pharma Co., Ltd. romanized国药准字H200000652026/05/250.25μgDrug that passed quality-and-efficacy consistency evaluationCDE
Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanizedNan Tong Hua Shan Pharma Co., Ltd. romanized国药准字H202641572026/04/290.5μgGeneric approved under the new chemical-drug registration classificationCDE
Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanizedNan Tong Hua Shan Pharma Co., Ltd. romanized国药准字H202641562026/04/290.25μgGeneric approved under the new chemical-drug registration classificationCDE
Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanizedRen Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized国药准字H202641132026/04/210.25μgGeneric approved under the new chemical-drug registration classificationCDE
Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanizedRen Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized国药准字H202641142026/04/210.5μgGeneric approved under the new chemical-drug registration classificationCDE
Guangzhou Bai Yun Shan Xing Qun (Pharma) Co., Ltd. romanizedGuangzhou Bai Yun Shan Xing Qun (Pharma) Co., Ltd. romanized国药准字H200205012026/02/030.25μgDrug that passed quality-and-efficacy consistency evaluationCDE
Guangzhou Bai Yun Shan Xing Qun (Pharma) Co., Ltd. romanizedGuangzhou Bai Yun Shan Xing Qun (Pharma) Co., Ltd. romanized国药准字H200518612026/02/030.5μgDrug that passed quality-and-efficacy consistency evaluationCDE
Da Lian Mei Chuang Pharma Co., Ltd. romanizedDa Lian Mei Chuang Pharma Co., Ltd. romanized国药准字H202633512026/02/020.25μgGeneric approved under the new chemical-drug registration classificationCDE
Da Lian Mei Chuang Pharma Co., Ltd. romanizedDa Lian Mei Chuang Pharma Co., Ltd. romanized国药准字H202633502026/02/020.5μgGeneric approved under the new chemical-drug registration classificationCDE
Dong Hai Pharmaceutical (Hebei) Co., Ltd. romanizedDong Hai Pharmaceutical (Hebei) Co., Ltd. romanized国药准字H202632442026/01/270.25μgGeneric approved under the new chemical-drug registration classificationCDE
Beijing Wan Hui Shuang He Pharma Co., Ltd. romanizedHua Run Shuang He Pharma Co., Ltd. romanized国药准字H202556722025/10/140.25μgGeneric approved under the new chemical-drug registration classificationCDE
Kunming Bei Ke Nuo Dun Pharmaceutical Co., Ltd. romanizedKunming Bei Ke Nuo Dun Pharmaceutical Co., Ltd. romanized国药准字H200103202021/02/020.25μgDrug that passed quality-and-efficacy consistency evaluationCDE
Zheng Da Pharmaceutical (Qingdao) Co., Ltd. romanizedZheng Da Pharmaceutical (Qingdao) Co., Ltd. romanized国药准字H199911142021/01/220.25μgDrug that passed quality-and-efficacy consistency evaluationCDE
LEO Pharma A/SLEO Pharma A/SH201305131998/07/090.25μgImported originator drugCDE
Teva Pharmaceutical Industries Ltd.Teva Pharmaceutical Industries Ltd.H20171202;H201712031993/03/250.25μgImported originator drugCDE

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: 24 distinct approval numbers and 14 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Da Lian Mei Chuang Pharma Co., Ltd. romanized国药准字H202633500.5μgCategory BXA11CCA017E002010101121NHSA
Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized国药准字H202641130.25μgCategory BXA11CCA017E002010109981NHSA
Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized国药准字H202641560.25μgCategory BXA11CCA017E002010183641NHSA
An Rui Pharmaceutical (Hebei) Co., Ltd. romanized国药准字H202632440.25μgCategory BXA11CCA017E002010184599NHSA
Da Lian Mei Chuang Pharma Co., Ltd. romanized国药准字H202633500.5μgCategory BXA11CCA017E002010201121NHSA
Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized国药准字H202641560.25μgCategory BXA11CCA017E002010283641NHSA
An Rui Pharmaceutical (Hebei) Co., Ltd. romanized国药准字H202632440.25μgCategory BXA11CCA017E002010284599NHSA
Da Lian Mei Chuang Pharma Co., Ltd. romanized国药准字H202633500.5μgCategory BXA11CCA017E002010301121NHSA
Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized国药准字H202641560.25μgCategory BXA11CCA017E002010383641NHSA
An Rui Pharmaceutical (Hebei) Co., Ltd. romanized国药准字H202632440.25μgCategory BXA11CCA017E002010384599NHSA
An Rui Pharmaceutical (Hebei) Co., Ltd. romanized国药准字H202632440.25μgCategory BXA11CCA017E002010484599NHSA
Da Lian Mei Chuang Pharma Co., Ltd. romanized国药准字H202633510.25μgCategory BXA11CCA017E002020101121NHSA
Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized国药准字H202641140.5μgCategory BXA11CCA017E002020109981NHSA
Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized国药准字H202641570.5μgCategory BXA11CCA017E002020183641NHSA
Da Lian Mei Chuang Pharma Co., Ltd. romanized国药准字H202633510.25μgCategory BXA11CCA017E002020201121NHSA
Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized国药准字H202641570.5μgCategory BXA11CCA017E002020283641NHSA
Da Lian Mei Chuang Pharma Co., Ltd. romanized国药准字H202633510.25μgCategory BXA11CCA017E002020301121NHSA
Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized国药准字H202641570.5μgCategory BXA11CCA017E002020383641NHSA
Hua Run Shuang He Pharma Co., Ltd. romanized国药准字H200741090.25μgCategory BXA11CCA017E002010100143NHSA
Beijing Wan Hui Shuang He Pharma Co., Ltd. romanized国药准字H202556720.25μgCategory BXA11CCA017E002010100176NHSA
Guangzhou Bai Yun Shan Xing Qun (Pharma) Co., Ltd. romanized国药准字H200205010.25μgCategory BXA11CCA017E002010100423NHSA
Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized国药准字H200106180.25μgCategory BXA11CCA017E002010100805NHSA
Nan Tong Hua Shan Pharma Co., Ltd. romanized国药准字H200000650.25μgCategory BXA11CCA017E002010101620NHSA
Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized国药准字H199911140.25μgCategory BXA11CCA017E002010104036NHSA
Teva Pharmaceutical Industries Ltd.国药准字J201710900.25μgCategory BXA11CCA017E002010105580NHSA
Teva Pharmaceutical Industries Ltd.H201712020.25μgCategory BXA11CCA017E002010178914NHSA
CHEPLAPHARM Arzneimittel GmbH国药准字HJ201305130.25μgCategory BXA11CCA017E002010179051NHSA
Hua Run Shuang He Pharma Co., Ltd. romanized国药准字H200741090.25μgCategory BXA11CCA017E002010200143NHSA
Beijing Wan Hui Shuang He Pharma Co., Ltd. romanized国药准字H202556720.25μgCategory BXA11CCA017E002010200176NHSA
Guangzhou Bai Yun Shan Xing Qun (Pharma) Co., Ltd. romanized国药准字H200205010.25μgCategory BXA11CCA017E002010200423NHSA
Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized国药准字H200106180.25μgCategory BXA11CCA017E002010200805NHSA
Nan Tong Hua Shan Pharma Co., Ltd. romanized国药准字H200000650.25μgCategory BXA11CCA017E002010201620NHSA
Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized国药准字H199911140.25μgCategory BXA11CCA017E002010204036NHSA
Teva Pharmaceutical Industries Ltd.国药准字J201710900.25μgCategory BXA11CCA017E002010205580NHSA
Teva Pharmaceutical Industries Ltd.H201712020.25μgCategory BXA11CCA017E002010278914NHSA
Nan Tong Hua Shan Pharma Co., Ltd. romanized国药准字H200000650.25μgCategory BXA11CCA017E002010301620NHSA
Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized国药准字H199911140.25μgCategory BXA11CCA017E002010304036NHSA
Kunming Bei Ke Nuo Dun Pharmaceutical Co., Ltd. romanized国药准字H200103200.25μgCategory BXA11CCA017E002010305580NHSA
Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized国药准字H199911140.25μgCategory BXA11CCA017E002010404036NHSA
Kunming Bei Ke Nuo Dun Pharmaceutical Co., Ltd. romanized国药准字H200103200.25μgCategory BXA11CCA017E002010405580NHSA
Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized国药准字H199911140.25μgCategory BXA11CCA017E002010504036NHSA
Guangzhou Bai Yun Shan Xing Qun (Pharma) Co., Ltd. romanized国药准字H200518610.5μgCategory BXA11CCA017E002020100423NHSA
Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized国药准字H200106190.5μgCategory BXA11CCA017E002020100805NHSA
Nan Tong Hua Shan Pharma Co., Ltd. romanized国药准字H200000660.5μgCategory BXA11CCA017E002020101620NHSA
Teva Pharmaceutical Industries Ltd.国药准字J201710931μgCategory BXA11CCA017E002020105580NHSA
Teva Pharmaceutical Industries Ltd.H201712051μgCategory BXA11CCA017E002020178914NHSA
CHEPLAPHARM Arzneimittel GmbH国药准字HJ201305141μgCategory BXA11CCA017E002020179051NHSA
Guangzhou Bai Yun Shan Xing Qun (Pharma) Co., Ltd. romanized国药准字H200518610.5μgCategory BXA11CCA017E002020200423NHSA
Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanized国药准字H200106190.5μgCategory BXA11CCA017E002020200805NHSA
Da Lian Ao Sen Pharmaceutical Co., Ltd. romanized国药准字H200679030.25μgCategory BXA11CCA017E002020201137NHSA
Nan Tong Hua Shan Pharma Co., Ltd. romanized国药准字H200000660.5μgCategory BXA11CCA017E002020201620NHSA
Da Lian Ao Sen Pharmaceutical Co., Ltd. romanized国药准字H200679030.25μgCategory BXA11CCA017E002020301137NHSA
Nan Tong Hua Shan Pharma Co., Ltd. romanized国药准字H200000660.5μgCategory BXA11CCA017E002020301620NHSA
Da Lian Ao Sen Pharmaceutical Co., Ltd. romanized国药准字H200679030.25μgCategory BXA11CCA017E002020401137NHSA
Da Lian Ao Sen Pharmaceutical Co., Ltd. romanized国药准字H200679030.25μgCategory BXA11CCA017E002020501137NHSA
Da Lian Ao Sen Pharmaceutical Co., Ltd. romanized国药准字H200679030.25μgCategory BXA11CCA017E002020601137NHSA
Da Lian Ao Sen Pharmaceutical Co., Ltd. romanized国药准字H200679030.25μgCategory BXA11CCA017E002020701137NHSA
Da Lian Ao Sen Pharmaceutical Co., Ltd. romanized国药准字H200679030.25μgCategory BXA11CCA017E002020801137NHSA
Da Lian Ao Sen Pharmaceutical Co., Ltd. romanized国药准字H200679030.25μgCategory BXA11CCA017E002020901137NHSA
Da Lian Ao Sen Pharmaceutical Co., Ltd. romanized国药准字H200679030.25μgCategory BXA11CCA017E002021001137NHSA

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: 9 filings and 7 distinct first applicants.

Generic 6 · Supplement 3

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanizedCYHS2602098Generic2026/08/24Not stated by sourceCDE
Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanizedCYHS2602097Generic2026/08/24Not stated by sourceCDE
Da Lian Ao Sen Pharmaceutical Co., Ltd. romanizedCYHB2650174Supplement2026/08/20Not stated by sourceCDE
Qingdao Shuang Jing Pharma Co., Ltd. romanizedCYHS2601939Generic2026/08/10Not stated by sourceCDE
Shandong Jian Dao Pharmaceutical Co., Ltd. romanizedCYHS2600677Generic2026/03/19Not stated by sourceCDE
Shanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanizedCYHB2650008Supplement2026/01/08Not stated by sourceCDE
Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanizedCYHS2503283Generic2025/09/05Not stated by sourceCDE
Shijiazhuang Ke Ren Pharmaceuticals Technology Co., Ltd. romanizedCYHS2503282Generic2025/09/05Not stated by sourceCDE
Qingdao Guo Xin Pharmaceutical Co., Ltd. romanizedCYHB2501261Supplement2025/06/27Not stated by sourceCDE
New generic filings in 2026

Loaded records: 4 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanizedCYHS2602098Generic2026/08/24Not stated by sourceCDE
Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanizedCYHS2602097Generic2026/08/24Not stated by sourceCDE
Qingdao Shuang Jing Pharma Co., Ltd. romanizedCYHS2601939Generic2026/08/10Not stated by sourceCDE
Shandong Jian Dao Pharmaceutical Co., Ltd. romanizedCYHS2600677Generic2026/03/19Not stated by sourceCDE
API registrations

Non-component matches: 9 companies with A status and 4 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
阿法骨化醇 · No verified English nameHebei Chuang Jian Pharma Co., Ltd. romanizedY20240001503IExact ingredient2025/07/03CDE
阿法骨化醇 · No verified English nameFormosa Laboratories, Inc.Y20230000706AExact ingredient2026/05/20CDE
阿法骨化醇 · No verified English nameShanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanizedY20230000101AExact ingredient2024/09/24CDE
阿法骨化醇 · No verified English nameWuxi Fu Qi Pharmaceutical Co., Ltd. romanizedY20210000218IExact ingredient2021/04/13CDE
阿法骨化醇 · No verified English nameYaoPharma Co., Ltd.Y20190009700AExact ingredient—CDE
阿法骨化醇 · No verified English nameQingdao Guo Xin Pharmaceutical Co., Ltd. romanizedY20190009399AExact ingredient2025/01/15CDE
阿法骨化醇 · No verified English nameHua Run Shuang He Pharma Co., Ltd. romanizedY20190006915AExact ingredient2023/03/24CDE
阿法骨化醇 · No verified English nameZhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.Y20190002277AExact ingredient2024/12/07CDE
阿法骨化醇 · No verified English nameYaoPharma Co., Ltd.Y20180001705AExact ingredient2025/09/27CDE
阿法骨化醇 · No verified English nameZheng Da Pharmaceutical (Qingdao) Co., Ltd. romanizedY20180000360IExact ingredient2018/08/27CDE
阿法骨化醇 · No verified English nameNanjing Hai Rong Pharmaceutical Co., Ltd. romanizedY20180000715AExact ingredient2025/03/23CDE
阿法骨化醇 · No verified English nameShanghai Xin Yi Wan Xiang Pharma Co., Ltd. romanizedY20170001885IExact ingredient—CDE
阿法骨化醇 · No verified English nameTai Yao Chemical Co., Ltd. romanizedY20170000266AExact ingredient2022/09/05CDE
阿法骨化醇 · No verified English nameCARBOGEN AMCIS B.V.Y20170000231AExact ingredient2024/11/20CDE

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. 2026/08/24Accepted

    Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanized

    CYHS2602098

    Fact date: 2026/08/24 · Site observation date: 2026/10/22

    View source ↗
  2. 2026/08/24Accepted

    Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized; Da Lian Mei Chuang Pharma Co., Ltd. romanized

    CYHS2602097

    Fact date: 2026/08/24 · Site observation date: 2026/10/22

    View source ↗
  3. 2026/08/20Accepted

    Da Lian Ao Sen Pharmaceutical Co., Ltd. romanized

    CYHB2650174

    Fact date: 2026/08/20 · 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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