DRUG MASTER FILE SUBMISSION STATUS TO THE HEALTH AUTHORITIES
-
PRODUCT
USDMF
EDMF
CEP
CDMF
Australia
JAPAN
Korea
ROW*
Aripiprazole
1
0
0
0
1
0
0
0
Anastrozole
0
29
0
1
0
0
0
1
ATC-AT1 (Drug substance intermediates)
1
0
0
1
0
0
0
0
Atorvastatin Calcium
1
16
0
0
0
1
0
2
Acamprosate Calcium
1
0
1
0
0
0
0
1
Clarithromycin
1
13
1
1
0
1
1
3
Clarithromycin Granules (42%)
0
2
0
0
0
0
1
0
Clarithromycin (Cyclohexane route)
1
25
1
1
0
0
0
0
Clopidogrel besylate
0
28
0
0
1
0
0
0
Clopidogrel bisulphate
0
0
0
0
0
0
0
2
Clarithromycin Citrate
1
21
0
0
0
0
0
2
Donepezil Hydrochloride
1
21
0
1
1
0
0
0
Fexofenadine Hydrochloride
0
27
1
0
0
0
0
1
Ezetimibe
0
0
0
0
0
0
1
0
Letrozole
1
8
1
1
1
0
0
0
Nateglinide
1
0
0
0
0
0
0
0
Naratriptan Hydrochloride
1
0
0
0
0
0
0
0
Pioglitazone Hydrochloride
1
0
0
1
1
1
0
1
Quetiapine fumarate
1
16
0
1
0
0
0
1
Ropinirole Hydrochloride
1
28
0
1
0
0
0
0
Risedronate Sodium
1
0
0
1
0
1
1
0
Venlafaxine Hydrochloride
1
0
0
1
0
1
1
0
Total number
16
234
5
10
5
4
4
14
* ROW : Taiwan 02, Russian 06; Singapore 06
