Tauroursodeoxycholic Acid Capsules

As of 13 November 2026, for Tauroursodeoxycholic Acid Capsules, 2 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 1 holder.

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

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
Coverage: Source dates and limits ↓

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.

Catalogue holders1View records ↓ Under-review filings2View records ↓ This year’s generic filers2View records ↓ NHSA approval numbers2View records ↓ API companies with A status1View records ↓

Chemical-drug catalogue

Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 0 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holder	Manufacturer	Approval number	Approved	Strength / specification	Catalogue category (source text)	View source
Bruschettini S.r.l.	DOPPEL FARMACEUTICI S.R.L.	H20150398	2006/07/25	250mg	Imported originator drug	CDE

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: 2 distinct approval numbers and 1 companies.

Company / applicant	Approval number	Strength / specification	NHSA class	NHSA drug code	View source
Bruschettini S.r.l.	H20150398	250mg	Not stated by source	XA05AAN068E001010178315	NHSA
Bruschettini S.r.l.	国药准字HJ20150398	250mg	Not stated by source	XA05AAN068E001020178315	NHSA

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: 2 filings and 2 distinct first applicants.

Generic 2

Current under-review applications
Company / applicant	Acceptance number	Application type	Accepted	Strength / specification	View source
Hubei Zhi Hua Pharmaceuticals Technology Co., Ltd. romanized; Hubei Duo Rui Pharma Co., Ltd. romanized	CYHS2602567	Generic	2026/10/19	Not stated by source	CDE
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized	CYHS2602167	Generic	2026/08/31	Not stated by source	CDE

New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicant	Acceptance number	Application type	Accepted	Strength / specification	View source
Hubei Zhi Hua Pharmaceuticals Technology Co., Ltd. romanized; Hubei Duo Rui Pharma Co., Ltd. romanized	CYHS2602567	Generic	2026/10/19	Not stated by source	CDE
Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized	CYHS2602167	Generic	2026/08/31	Not stated by source	CDE

API registrations

Non-component matches: 1 companies with A status and 1 I-status records. Component matches are listed separately and excluded from these counts.

Name	Company / applicant	Registration number	Status	Name match	Source update date	View source
牛磺熊去氧胆酸 · No verified English name	Zhong Shan Bai Ling Bio Technology Co., Ltd. romanized	Y20230000982	A	Exact ingredient	2025/10/14	CDE
牛磺熊去氧胆酸 · No verified English name	Sichuan Ming Xin Pharma Co., Ltd. romanized	Y20170001359	I	Exact 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.

2026/10/19Accepted

Hubei Zhi Hua Pharmaceuticals Technology Co., Ltd. romanized; Hubei Duo Rui Pharma Co., Ltd. romanized
CYHS2602567

Fact date: 2026/10/19 · Site observation date: 2026/10/22
View source ↗
2026/08/31Accepted

Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
CYHS2602167

Fact date: 2026/08/31 · 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

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.

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.

About the Chinese official sources

These pages organize dated records from Chinese official sources. English drug labels use verified official primary names; original Chinese source names remain available in CSV exports.

CDE — The Center for Drug Evaluation lists application acceptances and applications currently under review.
CDE catalogue — The chemical-drug catalogue lists approvals, marketing authorisation holders and the original inclusion categories.
NHSA — The National Healthcare Security Administration maintains medicine codes, companies and approval numbers; its database is not an application decision register.
NMPA — The National Medical Products Administration publishes delivery notices for approval documents and notifications. Loaded notices do not cover all historical approvals.
CDE API registry — The active pharmaceutical ingredient registry lists registrations and their A/I association-review status.
Drug Clinical Trial Registry — Public registration numbers, applicants, first-publication dates and original classifications/phases. States are dated site observations; revisions are not continuously tracked.

Official English name source: NMPA reference-product directory, Shaanxi MPA republication · 24-103

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