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Sign in to subscribeMethylprednisolone Tablets
As of 13 November 2026, for Methylprednisolone Tablets, 3 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 10 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 holders10View records ↓
Under-review filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers11View records ↓
API companies with A status11View records ↓
Chemical-drug catalogue
Loaded records: 10 holders; 2 in the quality-and-efficacy consistency-evaluation category, and 7 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 |
|---|---|---|---|---|---|---|
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | Jiangsu Peng Yao Pharma Co., Ltd. romanized | 国药准字H20264358 | 2026/05/19 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized | Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized | 国药准字H20254178 | 2025/05/13 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20253585 | 2025/03/11 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H20249247 | 2024/11/05 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20247189 | 2024/08/15 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 2024/06/11 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Han Hui Pharmaceutical Co., Ltd. romanized | Han Hui Pharmaceutical Co., Ltd. romanized | 国药准字H20237161 | 2023/11/23 | 4mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20213809 | 2021/10/26 | 16mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20213671 | 2021/08/25 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Tianjin Tian Yao Pharma Co., Ltd. romanized | 国药准字H20020224 | 2020/03/03 | 4mg | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Pfizer Italia s.r.l | Pfizer Italia Srl | H20150245 | 1999/03/08 | 4mg | 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: 11 distinct approval numbers and 10 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20264358 | 4mg | Category A | XH02ABJ061A001010100698 | NHSA |
| Jin Yao Pharma Co., Ltd. romanized | 国药准字H20020224 | 4mg | Category A | XH02ABJ061A001010100943 | NHSA |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H20249247 | 4mg | Category A | XH02ABJ061A001010103182 | NHSA |
| Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20253585 | 4mg | Category A | XH02ABJ061A001010103205 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001010104127 | NHSA |
| Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized | 国药准字H20213671 | 4mg | Category A | XH02ABJ061A001010104131 | NHSA |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20213809 | 16mg | Category A | XH02ABJ061A001010104735 | NHSA |
| Han Hui Pharmaceutical Co., Ltd. romanized | 国药准字H20237161 | 4mg | Category A | XH02ABJ061A001010109853 | NHSA |
| Pfizer Italia s.r.l | 国药准字HJ20150245 | 4mg | Category A | XH02ABJ061A001010178720 | NHSA |
| Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized | 国药准字H20254178 | 4mg | Category A | XH02ABJ061A001010183319 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20264358 | 4mg | Category A | XH02ABJ061A001010200698 | NHSA |
| Jin Yao Pharma Co., Ltd. romanized | 国药准字H20020224 | 4mg | Category A | XH02ABJ061A001010200943 | NHSA |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H20249247 | 4mg | Category A | XH02ABJ061A001010203182 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001010204127 | NHSA |
| Wuhan Jiu Long Ren Fu Pharma Co., Ltd. romanized | 国药准字H20254178 | 4mg | Category A | XH02ABJ061A001010283319 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20264358 | 4mg | Category A | XH02ABJ061A001010300698 | NHSA |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H20249247 | 4mg | Category A | XH02ABJ061A001010303182 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001010304127 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20264358 | 4mg | Category A | XH02ABJ061A001010400698 | NHSA |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H20249247 | 4mg | Category A | XH02ABJ061A001010403182 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001010404127 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20264358 | 4mg | Category A | XH02ABJ061A001010500698 | NHSA |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H20249247 | 4mg | Category A | XH02ABJ061A001010503182 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001010504127 | NHSA |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | 国药准字H20264358 | 4mg | Category A | XH02ABJ061A001010600698 | NHSA |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H20249247 | 4mg | Category A | XH02ABJ061A001010603182 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001010604127 | NHSA |
| Pu Yang Shi Hui Yuan Pharma Co., Ltd. romanized | 国药准字H20249247 | 4mg | Category A | XH02ABJ061A001010703182 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001010704127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001010804127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001010904127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001011004127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001011104127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001011204127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001011304127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001011404127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001011504127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001011604127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001011704127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001011804127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001011904127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001012004127 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243986 | 4mg | Category A | XH02ABJ061A001012104127 | NHSA |
| Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | 国药准字H20247189 | 4mg | Category A | XH02ABJ061A001020104735 | 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: 3 filings and 3 distinct first applicants.
Supplement 1 · Generic 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Pfizer Italia s.r.l; Pfizer Italia Srl | JYHB2600492 | Supplement | 2026/08/27 | Not stated by source | CDE |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2601743 | Generic | 2026/07/21 | Not stated by source | CDE |
| Tianjin Xin Yi Jin Jin Pharma Co., Ltd. romanized | CYHS2602621 | Generic | 2026/10/26 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2601743 | Generic | 2026/07/21 | Not stated by source | CDE |
| Tianjin Xin Yi Jin Jin Pharma Co., Ltd. romanized | CYHS2602621 | Generic | 2026/10/26 | Not stated by source | CDE |
API registrations
Non-component matches: 11 companies with A status and 7 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 |
|---|---|---|---|---|---|---|
| 甲泼尼龙 · No verified English name | Tianjin Xin Yi Jin Jin Pharma Co., Ltd. romanized | Y20260000804 | I | Exact ingredient | 2026/10/19 | CDE |
| 甲泼尼龙 · No verified English name | Jiangxi Yu Neng Pharmaceutical Co., Ltd. romanized | Y20260000126 | I | Exact ingredient | 2026/02/14 | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | Shandong Si Rui Pharma Co., Ltd. romanized | Y20250001065 | I | Salt-normalized ingredient | 2025/12/26 | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | Henan Li Hua Pharmaceutical Co., Ltd. romanized | Y20230000732 | A | Salt-normalized ingredient | 2026/03/13 | CDE |
| 甲泼尼龙 · No verified English name | Shandong Si Rui Pharma Co., Ltd. romanized | Y20240000084 | A | Exact ingredient | 2025/11/03 | CDE |
| 甲泼尼龙 · No verified English name | EUROAPI France | Y20230000994 | A | Exact ingredient | 2025/09/09 | CDE |
| 甲泼尼龙 · No verified English name | MAHARSHI PHARMA CHEM PRIVATE LIMITED | Y20230000498 | I | Exact ingredient | 2023/10/27 | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | BIOFER S.P.A. | Y20220000842 | A | Salt-normalized ingredient | 2025/04/04 | CDE |
| 甲泼尼龙 · No verified English name | Henan Li Hua Pharmaceutical Co., Ltd. romanized | Y20220000702 | A | Exact ingredient | 2026/07/09 | CDE |
| 甲泼尼龙 · No verified English name | Yue Yang Huan Yu Pharma Co., Ltd. romanized | Y20220000279 | I | Exact ingredient | 2022/05/09 | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanized | Y20210000507 | A | Salt-normalized ingredient | 2025/02/12 | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | Pfizer Inc. | Y20210000237 | A | Salt-normalized ingredient | 2024/01/17 | CDE |
| 甲泼尼龙 · No verified English name | Pfizer Inc. | Y20210000200 | A | Exact ingredient | 2024/01/17 | CDE |
| 甲泼尼龙 · No verified English name | Jin Yao Pharma Co., Ltd. romanized | Y20190009636 | A | Exact ingredient | 2024/09/30 | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | Newchem S.p.A. | Y20190009288 | A | Salt-normalized ingredient | 2025/06/09 | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20190008953 | A | Salt-normalized ingredient | 2024/01/25 | CDE |
| 甲泼尼龙 · No verified English name | Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized | Y20190008952 | A | Exact ingredient | 2024/04/30 | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized | Y20190007224 | A | Salt-normalized ingredient | — | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | Jin Yao Pharma Co., Ltd. romanized | Y20190004740 | A | Salt-normalized ingredient | 2025/08/16 | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20190001305 | A | Salt-normalized ingredient | 2025/04/22 | CDE |
| 甲泼尼龙 · No verified English name | Tianjin Tian Yao Pharma Co., Ltd. romanized | Y20190000234 | I | Exact ingredient | 2019/04/01 | CDE |
| 琥珀酸甲泼尼龙 · No verified English name | Jiangsu Wei Qi Da Pharma Co., Ltd. romanized | Y20180000958 | I | Salt-normalized ingredient | 2018/08/01 | CDE |
| 甲泼尼龙 · No verified English name | Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanized | Y20170001217 | A | Exact ingredient | 2026/06/12 | 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.
-
2026/10/26Accepted
Tianjin Xin Yi Jin Jin Pharma Co., Ltd. romanized
CYHS2602621
Fact date: 2026/10/26 · Site observation date: 2026/10/27
View source ↗ -
2026/08/27Accepted
Pfizer Italia s.r.l; Pfizer Italia Srl
JYHB2600492
Fact date: 2026/08/27 · 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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