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DRUG MASTER FILE SUBMISSION STATUS TO THE HEALTH AUTHORITIES

PRODUCT

USDMF

EDMF

CEP

China

Australia

JAPAN

New Zealand

Korea

ROW*

Aripiprazole

1

0

0

0

1

0

1

1

2

Anastrozole

1

31

1

1

1

0

1

0

4

ATC-AT1 (Drug substance intermediates)

1

0

0

1

0

0

0

0

0

Atorvastatin Calcium

1

33

1

0

0

1

1

1

2

Acamprosate Calcium

1

0

1

0

0

0

0

0

1

Betamethasone Valerate

0

0

0

0

0

0

0

0

1

Betamethasone Dipropionate

0

0

0

0

0

0

0

0

1

Clarithromycin

1

13

1

1

0

1

0

1

3

Clarithromycin Pure

0

0

0

0

0

0

0

0

3

Clarithromycin Granules (42%)

0

2

0

0

0

0

0

1

0

Clarithromycin Granules (27.5%)

0

1

0

0

0

0

0

0

0

Clarithromycin (Cyclohexane route)

1

26

1

1

0

0

0

0

0

Clopidogrel Besylate

0

28

0

0

1

0

0

1

0

Clarithromycin Citrate

1

26

0

0

0

0

0

0

4

Cinacalcet Hydrochloride

1

3

0

1

0

0

0

1

2

Clopidogrel CSA

1

10

0

0

0

0

0

1

0

Clopidogrel Bisulphate

1

0

1

0

0

0

0

1

4

Colesevelam Hydrochloride

1

0

0

0

0

0

0

0

0

Donepezil Hydrochloride

1

23

0

1

1

1

1

1

1

Dutasteride

1

0

0

0

0

0

0

1

2

Fexofenadine Hydrochloride

1

27

1

0

0

1

1

0

5

Ezetimibe

0

25

0

0

0

0

0

1

3

Letrozole

1

8

1

1

1

1

1

0

2

Nateglinide

1

0

0

1

0

0

0

0

0

Naratriptan Hydrochloride

1

8

0

0

0

0

0

0

0

Pioglitazone Hydrochloride

1

20

0

1

1

1

0

1

2

Quetiapine Fumarate

1

30

1

1

1

1

0

1

3

Ropinirole Hydrochloride

1

31

0

1

0

1

1

0

1

Risedronate Sodium

1

0

1

1

0

1

0

1

1

Temozolomide

1

0

0

0

0

0

0

0

1

Total number

23

345

10

12

7

8

7

14

48


* ROW : Taiwan 12, Russian 07, Singapore 09, China 12

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