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Pentoxifylline Modified Release Tablets

As of 13 November 2026, for Pentoxifylline Modified Release Tablets, 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 17 holders.

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

Last 90 days: Accepted: 1 application

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

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 1 of 1 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: Modified Release Tablets. 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

No listings in this group among the displayed brand names.

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
TRENTAL VALIDUS PHARMACEUTICALS LLC NDA 018631 · Product no. 001 TABLET, EXTENDED RELEASE ORAL HUMAN PRESCRIPTION DRUG 1984/08/30

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: 17 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 16 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Beijing Xing Hao Pharmaceuticals Co., Ltd. romanizedBeijing Xing Hao Pharmaceuticals Co., Ltd. romanized国药准字H202658352026/09/020.4gGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.国药准字H202656012026/08/040.4gGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanizedHangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized国药准字H202650212026/06/300.4gGeneric approved under the new chemical-drug registration classificationCDE
Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanizedGuangdong An Nuo Pharma Co., Ltd. romanized国药准字H202648862026/06/170.4gGeneric approved under the new chemical-drug registration classificationCDE
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanizedHunan Jiudian Pharmaceutical Co., Ltd国药准字H202648382026/06/170.4gGeneric approved under the new chemical-drug registration classificationCDE
HAINAN HUALON PHARMACEUTICAL CO.,LTDHAINAN HUALON PHARMACEUTICAL CO.,LTD国药准字H202635172026/03/030.4gGeneric approved under the new chemical-drug registration classificationCDE
Ben Xi Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanizedJilin Si Huan Pharmaceutical Co., Ltd. romanized国药准字H202635162026/03/030.4gGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Hui Ju Pharma Co., Ltd. romanizedHua Yi Tai Kang Pharma Co., Ltd. romanized国药准字H202634732026/02/250.4gGeneric approved under the new chemical-drug registration classificationCDE
Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanizedGuangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized国药准字H202560702025/11/250.4gGeneric approved under the new chemical-drug registration classificationCDE
Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanizedSuzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized国药准字H202558832025/11/040.4gGeneric approved under the new chemical-drug registration classificationCDE
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanizedLe Pu Pharmaceutical Technology Co., Ltd. romanized国药准字H202553772025/09/090.4gGeneric approved under the new chemical-drug registration classificationCDE
Guangdong Jun Kang Pharma Co., Ltd. romanizedTianjin Drug Research Institute Pharma Co., Ltd. romanized国药准字H202553472025/09/090.4gGeneric approved under the new chemical-drug registration classificationCDE
Jewim Pharmaceutical (Shandong) Co., Ltd.Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H202552552025/08/260.4gGeneric approved under the new chemical-drug registration classificationCDE
CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H202550082025/07/290.4gGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanizedZhejiang Sai Mo Pharmaceutical Co., Ltd. romanized国药准字H202548452025/07/150.4gNot stated by sourceCDE
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanizedJiangsu Yong An Pharmaceutical Co., Ltd. romanized国药准字H202535442025/03/040.4gGeneric approved under the new chemical-drug registration classificationCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202333102023/03/210.4gGeneric 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: 18 distinct approval numbers and 18 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized国药准字H202658350.4gCategory BXC04ADJ014A010010100198NHSA
Jiangsu Hui Ju Pharma Co., Ltd. romanized国药准字H202634730.4gCategory BXC04ADJ014A010010101411NHSA
Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized国药准字H202558830.4gCategory BXC04ADJ014A010010101679NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202333100.4gCategory BXC04ADJ014A010010102763NHSA
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H109702650.4gCategory BXC04ADJ014A010010102770NHSA
Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized国药准字H202550080.4gCategory BXC04ADJ014A010010102777NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H202552550.4gCategory BXC04ADJ014A010010104111NHSA
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.国药准字H202656010.4gCategory BXC04ADJ014A010010104685NHSA
HAINAN HUALON PHARMACEUTICAL CO.,LTD国药准字H202635170.4gCategory BXC04ADJ014A010010105781NHSA
Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized国药准字H202648860.4gCategory BXC04ADJ014A010010183014NHSA
Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized国药准字H202560170.4gCategory BXC04ADJ014A010010183114NHSA
Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized国药准字H202560700.4gCategory BXC04ADJ014A010010183238NHSA
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H202648380.4gCategory BXC04ADJ014A010010184019NHSA
Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized国药准字H202548450.4gCategory BXC04ADJ014A010010184160NHSA
Guangdong Jun Kang Pharma Co., Ltd. romanized国药准字H202553470.4gCategory BXC04ADJ014A010010184179NHSA
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized国药准字H202553770.4gCategory BXC04ADJ014A010010184207NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H202535440.4gCategory BXC04ADJ014A010010184221NHSA
Ben Xi Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanized国药准字H202635160.4gCategory BXC04ADJ014A010010184715NHSA
Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized国药准字H202658350.4gCategory BXC04ADJ014A010010200198NHSA
Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized国药准字H202558830.4gCategory BXC04ADJ014A010010201679NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202333100.4gCategory BXC04ADJ014A010010202763NHSA
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H109702650.4gCategory BXC04ADJ014A010010202770NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H202552550.4gCategory BXC04ADJ014A010010204111NHSA
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.国药准字H202656010.4gCategory BXC04ADJ014A010010204685NHSA
HAINAN HUALON PHARMACEUTICAL CO.,LTD国药准字H202635170.4gCategory BXC04ADJ014A010010205781NHSA
Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized国药准字H202648860.4gCategory BXC04ADJ014A010010283014NHSA
Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized国药准字H202560170.4gCategory BXC04ADJ014A010010283114NHSA
Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized国药准字H202560700.4gCategory BXC04ADJ014A010010283238NHSA
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H202648380.4gCategory BXC04ADJ014A010010284019NHSA
Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized国药准字H202548450.4gCategory BXC04ADJ014A010010284160NHSA
Guangdong Jun Kang Pharma Co., Ltd. romanized国药准字H202553470.4gCategory BXC04ADJ014A010010284179NHSA
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized国药准字H202553770.4gCategory BXC04ADJ014A010010284207NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H202535440.4gCategory BXC04ADJ014A010010284221NHSA
Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized国药准字H202558830.4gCategory BXC04ADJ014A010010301679NHSA
Shijiazhuang No.4 Pharmaceutical Co., Ltd.国药准字H202333100.4gCategory BXC04ADJ014A010010302763NHSA
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H109702650.4gCategory BXC04ADJ014A010010302770NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H202552550.4gCategory BXC04ADJ014A010010304111NHSA
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.国药准字H202656010.4gCategory BXC04ADJ014A010010304685NHSA
Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized国药准字H202648860.4gCategory BXC04ADJ014A010010383014NHSA
Hebei Yi Pin Biopharmaceuticals Co., Ltd. romanized国药准字H202560170.4gCategory BXC04ADJ014A010010383114NHSA
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H202648380.4gCategory BXC04ADJ014A010010384019NHSA
Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized国药准字H202548450.4gCategory BXC04ADJ014A010010384160NHSA
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized国药准字H202553770.4gCategory BXC04ADJ014A010010384207NHSA
Suzhou Zhong Hua Medicines Gong Ye Co., Ltd. romanized国药准字H202558830.4gCategory BXC04ADJ014A010010401679NHSA
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H109702650.4gCategory BXC04ADJ014A010010402770NHSA
Jewim Pharmaceutical (Shandong) Co., Ltd.国药准字H202552550.4gCategory BXC04ADJ014A010010404111NHSA
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H202648380.4gCategory BXC04ADJ014A010010484019NHSA
Hangzhou Fu Ou Pharmaceuticals Technology Co., Ltd. romanized国药准字H202548450.4gCategory BXC04ADJ014A010010484160NHSA
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized国药准字H202553770.4gCategory BXC04ADJ014A010010484207NHSA
CSPC OUYI PHARMACEUTICAL CO., LTD.国药准字H109702650.4gCategory BXC04ADJ014A010010502770NHSA
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H202648380.4gCategory BXC04ADJ014A010010584019NHSA
Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized国药准字H202553770.4gCategory BXC04ADJ014A010010584207NHSA
Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized国药准字H202648380.4gCategory BXC04ADJ014A010010684019NHSA

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 6 distinct first applicants.

Supplement 1 · Generic 5

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Hefei Guo Gao Pharma Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanizedCYHB2601752Supplement2026/09/17Not stated by sourceCDE
Jiangsu He Chen Pharma Co., Ltd. romanizedCYHS2500044Generic2025/01/04Not stated by sourceCDE
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanizedCYHS2600403Generic2026/02/07Not stated by sourceCDE
Heilongjiang Yi Da Hong Pharma Co., Ltd. romanizedCYHS2601283Generic2026/06/04Not stated by sourceCDE
Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanizedCYHS2600230Generic2026/01/20Not stated by sourceCDE
Huayi Pharmaceuticals (Anhui) Co., Ltd.CYHS2403035Generic2024/09/12Not 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
Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized; Jiangsu Yong An Pharmaceutical Co., Ltd. romanizedCYHS2600403Generic2026/02/07Not stated by sourceCDE
Heilongjiang Yi Da Hong Pharma Co., Ltd. romanizedCYHS2601283Generic2026/06/04Not stated by sourceCDE
Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanizedCYHS2600230Generic2026/01/20Not stated by sourceCDE
API registrations

Non-component matches: 15 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
己酮可可碱 · No verified English nameDan Dong Yi Chuang Pharma Co., Ltd. romanizedY20250000604IExact ingredient2025/07/16CDE
己酮可可碱 · No verified English nameHebei Yi Pin Pharmaceutical Co., Ltd. romanizedY20240000724IExact ingredient2024/07/24CDE
己酮可可碱 · No verified English nameJilin Hui Kang Pharmaceutical Co., Ltd. romanizedY20240000402AExact ingredient2025/12/10CDE
己酮可可碱 · No verified English nameChi Feng Wan Ze Pharma Co., Ltd. romanizedY20230001239AExact ingredient2025/11/03CDE
己酮可可碱 · No verified English nameJiu Quan Da De Li Pharmaceutical Co., Ltd. romanizedY20230000412AExact ingredient2025/04/07CDE
己酮可可碱 · No verified English nameNan Tong Chang You Pharma Technology Co., Ltd. romanizedY20230000230AExact ingredient2025/08/10CDE
己酮可可碱 · No verified English nameSUN PHARMACEUTICAL INDUSTRIES LTD.Y20220000937AExact ingredient2024/11/07CDE
己酮可可碱 · No verified English nameAnhui Heng Xing Pharmaceutical Co., Ltd. romanizedY20220000743AExact ingredient2024/08/10CDE
己酮可可碱 · No verified English nameShanghai Xu Dong Hai Pu Pharma Co., Ltd. romanizedY20220000799AExact ingredient2024/05/30CDE
己酮可可碱 · No verified English nameHikal LimitedY20210001229IExact ingredient2022/04/29CDE
己酮可可碱 · No verified English namePHARMACEUTICAL WORKS POLPHARMA S.A.Y20210000211AExact ingredient2024/07/09CDE
己酮可可碱 · No verified English nameChongqing Rui Po Lai Pharmaceutical Co., Ltd. romanizedY20210000669AExact ingredient2025/01/27CDE
己酮可可碱 · No verified English nameFLEMING LABORATORIES LTDY20210000649AExact ingredient2025/06/08CDE
己酮可可碱 · No verified English nameBAKUL PHARMA PRIVATE LIMITEDY20200001449AExact ingredient2025/12/25CDE
己酮可可碱 · No verified English nameHebei Guang Xiang Pharmaceutical Co., Ltd. romanizedY20200001394AExact ingredient2026/10/13CDE
己酮可可碱 · No verified English nameSOLARA ACTIVE PHARMA SCIENCES LIMITEDY20200001064AExact ingredient2023/05/16CDE
己酮可可碱 · No verified English nameShi Yao Innovation Pharmaceutical Co., Ltd. romanizedY20190005020AExact ingredient2025/06/12CDE
己酮可可碱 · No verified English nameSanofi India LimitedY20170001717IExact ingredient—CDE
己酮可可碱 · No verified English nameZAKLADY FARMACEUTYCZNE POLPHARMA S.A.Y20170000764AExact ingredient2026/07/24CDE

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. 2026/09/17Accepted

    Hefei Guo Gao Pharma Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized

    CYHB2601752

    Fact date: 2026/09/17 · Site observation date: 2026/10/21

    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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