Monthly
US$200
Billed every month
Sign in to subscribeBilastine Tablets
As of 13 November 2026, for Bilastine Tablets, 7 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 3 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 applications
Current coverage may be incomplete
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 holders3View records ↓
Under-review filings7View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers4View records ↓
API companies with A status6View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20264078 | 2026/04/21 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253972 | 2025/04/22 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20249275 | 2024/11/05 | 20mg | Generic approved under the new chemical-drug registration classification | 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: 4 distinct approval numbers and 4 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20249275 | 20mg | Not stated by source | XR06AXB258A001010101447 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253972 | 20mg | Not stated by source | XR06AXB258A001010104188 | NHSA |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20264078 | 20mg | Not stated by source | XR06AXB258A001010104393 | NHSA |
| Menarini International Operations Luxembourg S.A. | 国药准字HJ20230083 | 20mg | Not stated by source | XR06AXB258A001010184809 | NHSA |
| Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20249275 | 20mg | Not stated by source | XR06AXB258A001010201447 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253972 | 20mg | Not stated by source | XR06AXB258A001010204188 | NHSA |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20264078 | 20mg | Not stated by source | XR06AXB258A001010204393 | NHSA |
| Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20249275 | 20mg | Not stated by source | XR06AXB258A001010301447 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253972 | 20mg | Not stated by source | XR06AXB258A001010304188 | NHSA |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20264078 | 20mg | Not stated by source | XR06AXB258A001010304393 | NHSA |
| Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20249275 | 20mg | Not stated by source | XR06AXB258A001010401447 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253972 | 20mg | Not stated by source | XR06AXB258A001010404188 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253972 | 20mg | Not stated by source | XR06AXB258A001010504188 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253972 | 20mg | Not stated by source | XR06AXB258A001010604188 | 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: 7 filings and 7 distinct first applicants.
Generic 7
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | CYHS2602417 | Generic | 2026/09/28 | Not stated by source | CDE |
| Jiangsu Yue Xing Pharma Co., Ltd. romanized | CYHS2601852 | Generic | 2026/07/31 | Not stated by source | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2601998 | Generic | 2026/08/13 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2600148 | Generic | 2026/01/13 | Not stated by source | CDE |
| Fang Tai Da Biopharmaceuticals Technology Co., Ltd. romanized; Zhengzhou Zhuo Feng Pharmaceutical Co., Ltd. romanized | CYHS2503364 | Generic | 2025/09/11 | Not stated by source | CDE |
| Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized | CYHS2402979 | Generic | 2024/09/10 | Not stated by source | CDE |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2602704 | Generic | 2026/11/05 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 5 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | CYHS2602417 | Generic | 2026/09/28 | Not stated by source | CDE |
| Jiangsu Yue Xing Pharma Co., Ltd. romanized | CYHS2601852 | Generic | 2026/07/31 | Not stated by source | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2601998 | Generic | 2026/08/13 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2600148 | Generic | 2026/01/13 | Not stated by source | CDE |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2602704 | Generic | 2026/11/05 | Not stated by source | CDE |
API registrations
Non-component matches: 6 companies with A status and 12 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 |
|---|---|---|---|---|---|---|
| 比拉斯汀 · No verified English name | Zhejiang Hua Hai Jian Cheng Pharma Co., Ltd. romanized | Y20260000773 | I | Exact ingredient | 2026/09/04 | CDE |
| 比拉斯汀 · No verified English name | Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20260000515 | I | Exact ingredient | 2026/08/11 | CDE |
| 比拉斯汀 · No verified English name | Symed Labs Limited | Y20260000014 | I | Exact ingredient | 2026/02/05 | CDE |
| 比拉斯汀 · No verified English name | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized | Y20250001447 | I | Exact ingredient | 2026/02/02 | CDE |
| 比拉斯汀 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20250001163 | I | Exact ingredient | 2026/01/26 | CDE |
| 比拉斯汀 · No verified English name | Wuhan Wu Yao Pharmaceutical Co., Ltd. romanized | Y20250001379 | I | Exact ingredient | 2026/01/09 | CDE |
| 比拉斯汀 · No verified English name | Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20250000864 | I | Exact ingredient | 2025/08/29 | CDE |
| 比拉斯汀 · No verified English name | Zhuhai Hai Rui De Pharmaceutical Co., Ltd. romanized | Y20250000486 | I | Exact ingredient | 2025/07/23 | CDE |
| 比拉斯汀 · No verified English name | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | Y20250000668 | I | Exact ingredient | 2025/07/07 | CDE |
| 比拉斯汀 · No verified English name | Liaoning Hai Yi Pharmaceutical Co., Ltd. romanized | Y20250000251 | A | Exact ingredient | 2026/08/31 | CDE |
| 比拉斯汀 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20240000903 | A | Exact ingredient | 2026/06/18 | CDE |
| 比拉斯汀 · No verified English name | Lee Pharma Limited | Y20240000457 | I | Exact ingredient | 2024/06/17 | CDE |
| 比拉斯汀 · No verified English name | VIRUPAKSHA ORGANICS LIMITED | Y20230000643 | A | Exact ingredient | 2026/03/31 | CDE |
| 比拉斯汀 · No verified English name | METROCHEM API PVT LTD | Y20230000233 | A | Exact ingredient | 2025/09/22 | CDE |
| 比拉斯汀 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20230000151 | A | Exact ingredient | 2026/10/10 | CDE |
| 比拉斯汀 · No verified English name | Lian Yun Gang Gui Ke Pharma Co., Ltd. romanized | Y20210000822 | A | Exact ingredient | 2026/07/21 | CDE |
| 比拉斯汀 · No verified English name | SYMED LABS LIMITED | Y20210000552 | I | Exact ingredient | 2025/10/14 | CDE |
| 比拉斯汀 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20260000778 | I | Exact ingredient | 2026/11/06 | 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.
-
2026/11/05Accepted
Hainan Sai Li Ke Pharma Co., Ltd. romanized
CYHS2602704
Fact date: 2026/11/05 · Site observation date: 2026/11/06
View source ↗ -
2026/09/28Accepted
Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
CYHS2602417
Fact date: 2026/09/28 · 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.
Free follow
Follow changes to Bilastine Tablets
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Sign in to subscribeYearly
US$1,920
Billed every year
US$160 per month
Sign in to subscribeNeed more than 10 followed products or more than 5 recipients? Contact us.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy