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“Cefalexin”

26 results across 4 regulatory databases

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9
CEP Certificates
4
Japan DMF
9
KDMF Registrations
8
National Drug Code

CEP Certificates 9

EDQM COS list
View all 9 certificates
UR

Unimark Remedies Limited

India
Product
Cefalexin monohydrate
Withdrawn by Holder
Certificate number
R1-CEP 2004-064 - Rev 00
Substance number
708
Substance
UNIMARK REMEDIES LIMITED Mumbai IN
Type
Chemical
Country
India
Issue date
2011-01-24
End date
2026-07-03
CEP certificate Open certificate details

Japan Drug Master Files 4

JDMF
View all 4 files
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ACS DOBFAR S. p. A.

API
Product
Cephalexin
MF registration number
218MF10523
Registration category
APIs
Initial registration
2006-05-18
Latest registration
2018-04-17
Registered address
Viale Addetta, 4/12, 20067 Tribiano (Milan) Italy
Japan DMF record
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KDMF Registrations 9

Korea MFDS
View all 9 registrations
AL

Aging Life Science Co., Ltd.

Spain
Product
Cephalexin hydrate
Active
Registration Number
20140221-151-I-363-04
Initial Registration
2014-02-21
Last Modified
2016-04-19
Withdrawal Date
-
Applicant
Aging Life Science Co., Ltd.
Manufacturer
Centrient Pharmaceuticals Spain S.A.
MFDS Classification
Appendix 1
Final Annual Reporting Year
2025
Country
Spain
Manufacturing Facility
C/Ripolles, n2 Poligono Industrial URVASA Santa Perpetua de Mogoda 08130 BARCELONA SPAIN (POBox 425, 2600 AK Delft, The Netherlands)
KDMF registration

National Drug Code 8

US FDA NDC
View all 8 listings
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ACS Dobfar S.p.A

NDC
52946-0906
Nonproprietary Name
Cephalexin Monohydrate
Dosage Form
POWDER
Product Type
BULK INGREDIENT
Strength
1 kg/kg
Substance
CEPHALEXIN
Start Marketing Date
2009-12-09
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 9 Japan DMF 4 KDMF Registrations 9 National Drug Code 8
FDA Inspections No records
Eudra GMP No records
CEP status breakdown
9 total
Valid 4 · 44%
Withdrawn 4 · 44%
Expired 1 · 11%