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“Bepotastine Besilate”

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3
Japan DMF
13
KDMF Registrations
4
National Drug Code

Japan Drug Master Files 3

JDMF
View all 3 files
HF

HANMI FINE CHEMICAL CO. , LTD.

API
Product
Bepotastine besilate
MF registration number
229MF10032
Registration category
APIs
Initial registration
2017-02-08
Latest registration
2023-06-21
Registered address
57, Gyeongje-ro, Siheung-si, Gyeonggi-do, Korea
Japan DMF record

KDMF Registrations 13

Korea MFDS
View all 13 registrations
AB

Ace Biopharm Co., Ltd.

India
Product
Bepotastine besylate
Active
Registration Number
20190926-209-J-357
Initial Registration
2019-09-26
Last Modified
-
Withdrawal Date
-
Applicant
Ace Biopharm Co., Ltd.
Manufacturer
Bal Pharma Limited
MFDS Classification
Appendix 1
Final Annual Reporting Year
2021
Country
India
Manufacturing Facility
61-B, Bommasandra Industrial Area Bangalore-560 099, India
KDMF registration
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National Drug Code 4

US FDA NDC
View all 4 listings
IS

Icrom S.r.l.

NDC
40700-0040
Nonproprietary Name
Bepotastine Besilate
Dosage Form
POWDER
Product Type
BULK INGREDIENT
Strength
1 g/g
Substance
BEPOTASTINE BESILATE
Start Marketing Date
2011-11-01
End Marketing Date
0000-00-00
DEA Schedule
-
Certified Through
2026-12-31
NDC product
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Related databases
3 of 6 have records
CEP Certificates No records
Japan DMF 3 KDMF Registrations 13 National Drug Code 4
FDA Inspections No records
Eudra GMP No records