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“Clopidogrel Bisulfate”

127 results across 4 regulatory databases

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30
CEP Certificates
11
Japan DMF
69
KDMF Registrations
28
National Drug Code

CEP Certificates 30

EDQM COS list
View all 30 certificates
AP

APARNA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN

India
Product
Clopidogrel hydrogen sulfate
Valid
Certificate number
CEP 2023-461 - Rev 00
Substance number
2531
Substance
APARNA PHARMACEUTICALS PRIVATE LIMITED Hyderabad IN
Type
Chemical
Country
India
Issue date
2025-08-18
End date
-
CEP certificate

Japan Drug Master Files 11

JDMF
View all 11 files
DC

Daito Co., Ltd.

API
Product
Clopidogrel sulfate
MF registration number
226MF10034
Registration category
APIs
Initial registration
2014-02-05
Latest registration
2024-05-15
Registered address
326 Yokamachi, Toyama City, Toyama Prefecture
Japan DMF record
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KDMF Registrations 69

Korea MFDS
View all 69 registrations
AB

Ace Biopharm Co., Ltd.

china
Product
Clopidogrel hydrogen sulfate
Active
Registration Number
20210518-129-H-386-55
Initial Registration
2021-05-18
Last Modified
-
Withdrawal Date
-
Applicant
Ace Biopharm Co., Ltd.
Manufacturer
Zenji Pharmaceuticals (Suzhou) Ltd.
MFDS Classification
Appendix 1
Final Annual Reporting Year
-
Country
china
Manufacturing Facility
No.122, Xuqing Road, Xuguan, Town Suzhou, Jiangsu China
KDMF registration

National Drug Code 28

US FDA NDC
View all 28 listings
AC

Apotex Corp.

NDC
60505-3992
Nonproprietary Name
clopidogrel bisulfate
Dosage Form
TABLET, FILM COATED
Product Type
DRUG FOR FURTHER PROCESSING
Strength
75 mg/1
Substance
CLOPIDOGREL BISULFATE
Start Marketing Date
2012-05-17
End Marketing Date
0000-00-00
DEA Schedule
-
Certified Through
2026-12-31
NDC product
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Related databases
4 of 6 have records
CEP Certificates 30 Japan DMF 11 KDMF Registrations 69 National Drug Code 28
FDA Inspections No records
Eudra GMP No records
CEP status breakdown
30 total
Valid 22 · 73%
Withdrawn 6 · 20%
Suspended 1 · 3%
Expired 1 · 3%