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Tacrolimus Sustained-release Capsules

As of 13 November 2026, for Tacrolimus Sustained-release Capsules, 6 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 9 holders.

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

Listed in the US FDA Orange Book as ASTAGRAF XL (NDA 204096, ASTELLAS PHARMA US INC).

Last 90 days: Accepted: 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

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 4 of 4 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: Sustained-release Capsules. 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

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
ASTAGRAF XL ASTELLAS PHARMA US INC NDA 204096 · Product no. 001, 002, 003 CAPSULE, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2013/07/19

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
PROGRAF ASTELLAS PHARMA US INC NDA 050708 · Product no. 001, 002 CAPSULE ORAL HUMAN PRESCRIPTION DRUG 1994/04/08
PROGRAF ASTELLAS PHARMA US INC NDA 050709 · Product no. 001 INJECTABLE INJECTION HUMAN PRESCRIPTION DRUG 1994/04/08
PROGRAF ASTELLAS PHARMA US INC NDA 050708 · Product no. 003 CAPSULE ORAL HUMAN PRESCRIPTION DRUG 1998/08/24
PROTOPIC LEO PHARMA AS NDA 050777 · Product no. 001, 002 OINTMENT TOPICAL HUMAN PRESCRIPTION DRUG 2000/12/08
ENVARSUS XR VELOXIS PHARMACEUTICALS INC NDA 206406 · Product no. 001, 002, 003 TABLET, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 2015/07/10
PROGRAF ASTELLAS PHARMA US INC NDA 210115 · Product no. 001, 002 FOR SUSPENSION ORAL HUMAN PRESCRIPTION DRUG 2018/05/24

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: 9 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 9 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanizedJilin Si Huan Pharmaceutical Co., Ltd. romanized国药准字H202640582026/04/210.5mgGeneric approved under the new chemical-drug registration classificationCDE
Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanizedJilin Si Huan Pharmaceutical Co., Ltd. romanized国药准字H202640572026/04/211mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu He Chen Pharma Co., Ltd. romanizedJiangsu He Chen Pharma Co., Ltd. romanized国药准字H202690582026/03/190.5mgGeneric approved under the new chemical-drug registration classificationCDE
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.国药准字H202556472025/09/300.5mgGeneric approved under the new chemical-drug registration classificationCDE
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.国药准字H202556462025/09/301mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu He Chen Pharma Co., Ltd. romanizedJiangsu He Chen Pharma Co., Ltd. romanized国药准字H202546802025/06/301mgGeneric approved under the new chemical-drug registration classificationCDE
Hainan He Rui Pharmaceutical Co., Ltd. romanizedHainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H202535572025/03/040.5mgGeneric approved under the new chemical-drug registration classificationCDE
Hainan He Rui Pharmaceutical Co., Ltd. romanizedHainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H202535562025/03/041mgGeneric approved under the new chemical-drug registration classificationCDE
CISEN PHARMACEUTICAL CO., LTD.Hua Yi Tai Kang Pharma Co., Ltd. romanized国药准字H202532422025/01/241mgGeneric approved under the new chemical-drug registration classificationCDE
CISEN PHARMACEUTICAL CO., LTD.Hua Yi Tai Kang Pharma Co., Ltd. romanized国药准字H202532412025/01/240.5mgGeneric approved under the new chemical-drug registration classificationCDE
Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202531652025/01/141mgGeneric approved under the new chemical-drug registration classificationCDE
Hunan Ke Lun Pharmaceutical Co., Ltd. romanizedHunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202531662025/01/140.5mgGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanizedHangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized国药准字H202441372024/06/251mgGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanizedHangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized国药准字H202441362024/06/250.5mgGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanizedHangzhou Zhong Mei Hua Dong Jiang Dong Pharmaceutical Co., Ltd. romanized国药准字H202432002024/02/235mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanizedChengdu Sheng Di Pharmaceuticals Co., Ltd. romanized国药准字H202234242022/06/280.5mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanizedChengdu Sheng Di Pharmaceuticals Co., Ltd. romanized国药准字H202234222022/06/285mgGeneric approved under the new chemical-drug registration classificationCDE
Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanizedChengdu Sheng Di Pharmaceuticals Co., Ltd. romanized国药准字H202234232022/06/281mgGeneric 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: 22 distinct approval numbers and 9 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Astellas Pharma Europe B.V.国药准字J201500550.5mgCategory BXL04ADT002E003010101076NHSA
Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized国药准字H202556461mgCategory BXL04ADT002E003010102777NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H202532410.5mgCategory BXL04ADT002E003010104127NHSA
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized国药准字H202441360.5mgCategory BXL04ADT002E003010104520NHSA
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202531651mgCategory BXL04ADT002E003010104948NHSA
Hainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H202535570.5mgCategory BXL04ADT002E003010105815NHSA
Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized国药准字H202234240.5mgCategory BXL04ADT002E003010180435NHSA
Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized国药准字H202640571mgCategory BXL04ADT002E003010182990NHSA
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized国药准字H202432005mgCategory BXL04ADT002E003010183516NHSA
Jiangsu He Chen Pharma Co., Ltd. romanized国药准字H202546801mgCategory BXL04ADT002E003010183879NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H202532410.5mgCategory BXL04ADT002E003010204127NHSA
Hainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H202535570.5mgCategory BXL04ADT002E003010205815NHSA
Astellas Pharma Europe B.V.国药准字HJ201500290.5mgCategory BXL04ADT002E003010279406NHSA
Astellas Pharma Europe B.V.国药准字J201500561mgCategory BXL04ADT002E003020101076NHSA
Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized国药准字H202556470.5mgCategory BXL04ADT002E003020102777NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H202532421mgCategory BXL04ADT002E003020104127NHSA
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized国药准字H202441371mgCategory BXL04ADT002E003020104520NHSA
Hunan Ke Lun Pharmaceutical Co., Ltd. romanized国药准字H202531660.5mgCategory BXL04ADT002E003020104948NHSA
Hainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H202535561mgCategory BXL04ADT002E003020105815NHSA
Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized国药准字H202234231mgCategory BXL04ADT002E003020180435NHSA
Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized国药准字H202640580.5mgCategory BXL04ADT002E003020182990NHSA
Jiangsu He Chen Pharma Co., Ltd. romanized国药准字H202690580.5mgCategory BXL04ADT002E003020183879NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H202532421mgCategory BXL04ADT002E003020204127NHSA
Hainan He Rui Pharmaceutical Co., Ltd. romanized国药准字H202535561mgCategory BXL04ADT002E003020205815NHSA
Astellas Pharma Europe B.V.国药准字HJ201500311mgCategory BXL04ADT002E003020279406NHSA
Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized国药准字H202234225mgCategory BXL04ADT002E003030180435NHSA

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: 6 filings and 3 distinct first applicants.

Generic 6

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanizedCYHS2602572Generic2026/10/19Not stated by sourceCDE
Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanizedCYHS2602571Generic2026/10/19Not stated by sourceCDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS2601292Generic2026/06/04Not stated by sourceCDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS2601291Generic2026/06/04Not stated by sourceCDE
Hefei Li Cheng Pharma Co., Ltd. romanizedCYHS2600740Generic2026/03/27Not stated by sourceCDE
Hefei Li Cheng Pharma Co., Ltd. romanizedCYHS2600739Generic2026/03/27Not stated by sourceCDE
New generic filings in 2026

Loaded records: 6 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanizedCYHS2602572Generic2026/10/19Not stated by sourceCDE
Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanizedCYHS2602571Generic2026/10/19Not stated by sourceCDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS2601292Generic2026/06/04Not stated by sourceCDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS2601291Generic2026/06/04Not stated by sourceCDE
Hefei Li Cheng Pharma Co., Ltd. romanizedCYHS2600740Generic2026/03/27Not stated by sourceCDE
Hefei Li Cheng Pharma Co., Ltd. romanizedCYHS2600739Generic2026/03/27Not stated by sourceCDE
API registrations

Non-component matches: 12 companies with A status and 8 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
他克莫司 · No verified English nameZhejiang Hai Xiang Pharma Co., Ltd. romanizedY20250000882IExact ingredient2025/09/02CDE
他克莫司 · No verified English nameBills Biotech Pvt. Ltd.Y20240000691IExact ingredient2024/10/10CDE
他克莫司 · No verified English nameSichuan Nuo Yi Sheng Pharma Co., Ltd. romanizedY20240000730AExact ingredient2025/12/17CDE
他克莫司 · No verified English nameName not romanizedY20240000073IExact ingredient2024/07/16CDE
他克莫司 · No verified English nameBiocon Biosphere LimitedY20240000135AExact ingredient2026/06/01CDE
他克莫司 · No verified English nameLu Nan Xin Shi Dai Bio Technology Co., Ltd. romanizedY20230001120AExact ingredient2026/05/20CDE
他克莫司 · No verified English nameBiocon LimitedY20220000745AExact ingredient2024/12/13CDE
他克莫司 · No verified English nameWuxi Fu Qi Pharmaceutical Co., Ltd. romanizedY20210000983AExact ingredient2024/04/13CDE
他克莫司 · No verified English nameCERES F&D IncorporatedY20210000344IExact ingredient2021/07/12CDE
他克莫司 · No verified English nameConcord Biotech LimitedY20210000143IExact ingredient2025/12/30CDE
他克莫司 · No verified English nameJiangsu Jiu Yang Biopharmaceutical Co., Ltd. romanizedY20210000274AExact ingredient2026/06/13CDE
他克莫司 · No verified English nameAstellas Pharma Inc.Y20190000843IExact ingredient2020/03/09CDE
他克莫司 · No verified English nameHangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanizedY20190009352AExact ingredient—CDE
他克莫司 · No verified English nameFujian Ke Rui Pharma Co., Ltd. romanizedY20190008905AExact ingredient2025/03/06CDE
他克莫司 · No verified English nameGuo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanizedY20190006989AExact ingredient2026/06/29CDE
他克莫司 · No verified English nameHua Bei Pharmaceutical Hua Sheng Co., Ltd. romanizedY20190006104AExact ingredient2025/08/08CDE
他克莫司 · No verified English nameHai Zheng Pharma (Hangzhou) Co., Ltd. romanizedY20190006081AExact ingredient2025/07/18CDE
他克莫司 · No verified English nameHangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanizedY20170001979AExact ingredient2023/03/24CDE
他克莫司 · No verified English nameTAPI Czech Industries s.r.o.Y20170000349AExact ingredient2025/05/08CDE
他克莫司 · No verified English nameShandong Xin Shi Dai Pharma Co., Ltd. romanizedY20170000052IExact ingredient—CDE
他克莫司 · No verified English nameBiocon LimitedY20170000011IExact ingredient—CDE

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. 2026/10/19Accepted

    Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized

    CYHS2602572

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

    View source ↗
  2. 2026/10/19Accepted

    Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized

    CYHS2602571

    Fact date: 2026/10/19 · 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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