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Company directoryChina company filings

Mylan Laboratories Limited

Check drug filings and source records for this company-name string.

Listed by the company name as recorded in the source, without merging affiliated entities.

Page reference 65aa0b2388

Complete CDE snapshot
2026/11/11 06:42
Matching scope
Loaded public-source records only

These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/11 06:42.

Drug filings

16 acceptance records as first applicant, grouped into 12 source drug names. Source data as of 2026/11/11 06:42.

Acceptance records are de-duplicated by acceptance number. Drug names are normalized only for width and whitespace; dosage forms and combinations remain separate. Application types are retained from the source. Expand a drug to inspect each record. Published drugs link to their drug pages; other names do not create new public drug pages.

No verified English name 1 records · Latest accepted 2026/02/25

Not stated by source · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JTH2600042Not stated by source2026/02/25Mylan Laboratories Limited; MYLAN IRELAND LTD; Shanghai Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanizedCDE ↗
No verified English name 1 records · Latest accepted 2023/11/10

Not stated by source · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JTH2300260Not stated by source2023/11/10Mylan Laboratories Limited; Mylan Ireland Limited; Shenyang Hong Qi Pharmaceutical Co., Ltd. romanizedCDE ↗
Mycophenolate Mofetil Capsules 1 records · Latest accepted 2023/09/20

Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHS2300118Import2023/09/20Mylan Laboratories Limited; Viatris Pharmaceuticals Co. Ltd.CDE ↗
Mirtazapine Tablets 2 records · Latest accepted 2023/09/20

Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHS2300120Import2023/09/20Mylan Laboratories Limited; Viatris Pharmaceuticals Co. Ltd.CDE ↗
JYHS2300119Import2023/09/20Mylan Laboratories Limited; Viatris Pharmaceuticals Co. Ltd.CDE ↗
Mycophenolate Sodium Enteric-coated Tablets 1 records · Latest accepted 2023/09/06

Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHS2300115Import2023/09/06Mylan Laboratories Limited; Viatris Pharmaceuticals Co. Ltd.CDE ↗
Levothyroxine Sodium Tablets 2 records · Latest accepted 2023/06/21

Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHS2300078Import2023/06/21Mylan Laboratories Limited; Viatris Pharmaceuticals Co. Ltd.CDE ↗
JYHS2300077Import2023/06/21Mylan Laboratories Limited; Viatris Pharmaceuticals Co. Ltd.CDE ↗
Hydroxychloroquine Sulfate Tablets 1 records · Latest accepted 2023/02/24

Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHS2300032Import2023/02/24Mylan Laboratories LimitedCDE ↗
Desloratadine Tablets 1 records · Latest accepted 2023/02/14

Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHS2300021Import2023/02/14Mylan Laboratories LimitedCDE ↗
Pantoprazole Enteric-Coated Tablets 2 records · Latest accepted 2023/01/12

Import · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHS2300003Import2023/01/12Mylan Laboratories Limited; Viatris Pharmaceuticals Co. Ltd.CDE ↗
JYHS2300002Import2023/01/12Mylan Laboratories Limited; Viatris Pharmaceuticals Co. Ltd.CDE ↗
Lanthanum Carbonate Chewable Tablets 1 records · Latest accepted 2021/12/28

Import · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JYHS2101062Import2021/12/28Mylan Laboratories LimitedCDE ↗
No verified English name 2 records · Latest accepted 2021/12/22

Not stated by source · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JTH2100726Not stated by source2021/12/22Mylan Laboratories Limited; Shenzhen Shi Fan Gu Pharma Co., Ltd. romanizedCDE ↗
JTH2100652Not stated by source2021/09/17Mylan Laboratories Limited; Hebei Long Hai Pharma Co., Ltd. romanizedCDE ↗
No verified English name 1 records · Latest accepted 2021/02/02

Not stated by source · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
JTH2100036Not stated by source2021/02/02Mylan Laboratories Limited; Da Lian Ke Xiang Technology Kai Fa Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

0 events from 2026/08/14 to 2026/11/11. CDE data as of 2026/11/11 06:42; NMPA data as of 2026/11/10 18:31.

This source was last successfully updated at 2026/11/10 18:31; current coverage may be incomplete.

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately. 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.

  1. No matching records were found in the currently loaded source data; coverage dates are listed below.

Under review

0 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/11 06:42.

Under review
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

Catalogue holder records

7 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/11 06:38. Manufacturer-only records are excluded.

DrugMarketing authorization holderManufacturerApproval numberApprovedCatalogue category (source text)View source
Mycophenolate Mofetil CapsulesMylan Laboratories LimitedMylan Laboratories Limited国药准字HJ202500982025/08/19Generic approved under the new chemical-drug registration classificationCDE ↗
Mirtazapine TabletsMylan Laboratories LimitedMylan Laboratories Limited国药准字HJ202500442025/04/15Generic approved under the new chemical-drug registration classificationCDE ↗
Mycophenolate Sodium Enteric-coated TabletsMylan Laboratories LimitedMylan Laboratories Limited国药准字HJ202500282025/03/11Not stated by sourceCDE ↗
Desloratadine TabletsMylan Laboratories LimitedMylan Laboratories Limited国药准字HJ202500112025/01/14Generic approved under the new chemical-drug registration classificationCDE ↗
Pantoprazole Enteric-Coated TabletsMylan Laboratories LimitedMylan Laboratories Limited国药准字HJ202400992024/09/19Generic approved under the new chemical-drug registration classificationCDE ↗
Pantoprazole Enteric-Coated TabletsMylan Laboratories LimitedMylan Laboratories Limited国药准字HJ202401002024/09/19Generic approved under the new chemical-drug registration classificationCDE ↗
Lanthanum Carbonate Chewable TabletsMylan Laboratories LimitedMylan Laboratories Limited国药准字HJ202301162023/10/18Generic approved under the new chemical-drug registration classificationCDE ↗

Only active catalogue records matching the source holder name are listed. A manufacturer role does not count as a holder record. The catalogue covers only part of the chemical-drug market; source categories do not establish complete market coverage or qualifications.

API registrations

5 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/11 06:40.

NameCompany / applicantRegistration numberStatusSource update dateView source
No verified English nameMylan Laboratories LimitedY20220000753I2023/01/11CDE ↗
No verified English nameMylan Laboratories LimitedY20190021221A2022/10/14CDE ↗
No verified English nameMylan Laboratories LimitedY20190000954I2020/01/10CDE ↗
No verified English nameMylan Laboratories LimitedY20190000955I2020/01/10CDE ↗
No verified English nameMylan Laboratories LimitedY20190000952I2020/01/03CDE ↗

Only loaded active API registrations not listed as cancelled are shown. A/I are source registration statuses. Records are listed by registration number and do not establish capacity or supply. The register does not identify the associated formulation.

Co-applicant records

24 acceptance records name this company after the first applicant. They are listed separately and are not included in first-applicant drug or filing counts. Source data as of 2026/11/11 06:42.

Co-applicant records
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
No verified English name JXHS2300120Import2023/12/12Mylan Ireland Limited; Mylan Laboratories Limited; Shenyang Hongqi Pharmaceutical Co. Ltd.CDE ↗
No verified English name JTH2300258Not stated by source2023/11/09Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2300160Not stated by source2023/07/04Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2300123Not stated by source2023/05/12Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2300027Not stated by source2023/02/02Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2300010Not stated by source2023/01/11Mylan Laboratories Limited (Unit 1); Mylan Laboratories Limited; Qi Lu Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2200188Not stated by source2022/09/14Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2200137Not stated by source2022/07/19Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2200075Not stated by source2022/04/15Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Bosentan Tablets JYHS2200026Import2022/03/15Mylan S.p.A.; Mylan Laboratories Limited; Tianjin Happy Life Technology Co. Ltd.CDE ↗
Bosentan Tablets JYHS2200025Import2022/03/15Mylan S.p.A.; Mylan Laboratories Limited; Tianjin Happy Life Technology Co. Ltd.CDE ↗
No verified English name JTH2200030Not stated by source2022/02/18Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2200013Not stated by source2022/01/25Mylan Laboratories Limited (Unit-7); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2200004Not stated by source2022/01/07Mylan Laboratories Limited(Unit-7); Mylan Laboratories Limited; Chongqing Yao You Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2100694Not stated by source2021/11/23Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
Darunavir Tablets JYHS2101044Import2021/09/26Mylan S.A.S.; Mylan Laboratories LimitedCDE ↗
No verified English name JTH2100651Not stated by source2021/09/17Aurore Pharmaceutical Private Limited; Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2100648Not stated by source2021/09/13Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hainan Sai Li Ke Pharma Co., Ltd. romanizedCDE ↗
No verified English name JTH2100615Not stated by source2021/08/11Aurore Pharmaceutical Private Limited; Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2100587Not stated by source2021/08/03Mylan Laboratories Limited (Unit-8); Mylan Laboratories Limited; Hainan Sai Li Ke Pharma Co., Ltd. romanizedCDE ↗
No verified English name JTH2100576Not stated by source2021/07/20Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2100531Not stated by source2021/05/18Mylan Laboratories Limited (Unit-1); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2100530Not stated by source2021/05/18Mylan Laboratories Limited (Unit-7); Mylan Laboratories Limited; Hui Rui Pharmaceutical Co., Ltd. romanizedCDE ↗
No verified English name JTH2100028Not stated by source2021/02/05Mylan Laboratories Limited (Unit-11); Mylan Laboratories Limited; Xin Ling Pharmaceuticals Technology (Shenzhen) Co., Ltd. romanizedCDE ↗

How current is each source?

CDE acceptances and review
Last successful update: 2026/11/11 06:42
Chemical-drug catalogue
Last successful update: 2026/11/11 06:38
Full API register
Last successful update: 2026/11/11 06:40
NMPA drug delivery notices
Last successful update: 2026/11/10 18:31 · Current coverage may be incomplete

First index-page publication dates: — to —; 0 pages pending. Covers loaded notices only, not a complete historical approval database.

Listed by the company name as recorded in the source, without merging affiliated entities.

This page summarizes loaded records only, without new source queries or collection. Parent companies, subsidiaries, former names and aliases are not merged. Counts from different sources must not be added together. No loaded record does not establish the absence of a filing or registration. Check original records where coverage is incomplete, an update has failed, or a source lies outside the loaded scope.

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.

Drug names use verified official English names only. Missing names are shown as No verified English name, linking to a Chinese page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized. Original statutory reference numbers are the sole visible Chinese exception.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Chinese free text is not displayed; use the source links or source-name columns in CSV exports.