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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Archimica to the U.S. FDA. Original Data : FDA Website

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01 2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOESTER (SOL.) - VARESE,ITALY (1)

02 2-CHLORO-4.5-DIFLUOROPHENYL-B-KETOESTER - VARESE, ITALY (1)

03 ADENOSINE (1)

04 AMRINONE, USP (1)

05 ATENOLOL (1)

06 AZACITIDINE (1)

07 BENDAMUSTINE HYDROCHLORIDE HYDRATE (1)

08 BENZOCAINE USP-EP (1)

09 BROENAC SODIUM (1)

10 BULK CRUDE PROPOFOL (1)

11 BUSPIRONE HYDROCHLORIDE (1)

12 BUSULFAN (1)

13 CAPECITABINE (1)

14 CYTARABINE (1)

15 DESIPRAMINE HYDROCHLORIDE USP (1)

16 DIACEREIN (PROCESS I) (1)

17 DIACEREIN (PROCESS II) (1)

18 DISOPYRAMIDE PHOSPHATE (1)

19 DOXYLAMINE SUCCINATE USP (1)

20 ERYTHROMYCIN ETHYLSUCCINATE (1)

21 ERYTHROMYCIN STEARATE (1)

22 ETHYL-4-N(n-BUTYLAMINO) BENZOATE (1)

23 FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. (1)

24 FACILITY IN ORIGGIO (VARESE), ITALY (1)

25 FLUDARABINE PHOSPHATE (1)

26 GEMCITABINE HYDROCHLORIDE (1)

27 HYDRALAZINE HYDROCHLORIDE (1)

28 HYDRALAZINE HYDROCHLORIDE INJECTABLE GRADE (1)

29 HYDROXYUREA (1)

30 IMIPRAMINE HYDROCHLORIDE (1)

31 LITHIUM CARBONATE PHARMA GRADE (1)

32 NITRO-THIAZOLINEBULK (1)

33 OP 3300/15 (1)

34 OXCARBAZEPINE (1)

35 PIRENZEPINE BASE PURE (1)

36 PIRENZEPINE DIHYDROCHLORIDE (1)

37 RIBAVIRIN (1)

38 SANCYCLINE (1)

39 SUCRALFATE (1)

40 SULFAPYRIDINE (1)

41 TCC TRICLOCARBAN (3,4,4'-TRICHLORO CARBANILIDE) (1)

42 TERAZOSIN HYDROCHLORIDE (1)

43 TETRACYCLINE (1)

44 TETRACYCLINE HYDROCHLORIDE (1)

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01 ARCHIFAR LAB (4)

02 ARCHIMICA LTD (2)

03 ARCHIMICA SPA (25)

04 ARCHIMICA SRL (2)

05 EUTICALS SPA (10)

06 PRIME EUROPEAN THERAPEUTICALS SPA (EUTICALS SPA) (1)

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01 Italy (43)

02 U.S.A (1)

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01 Active (15)

02 Inactive (29)

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01 Complete (8)

02 Blank (36)

URL Supplier Web Content
EUTICALS SPA
Active
22232
Complete
2013-09-21
2013-09-17
2008-11-25
II
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ARCHIMICA SPA
Inactive
13193
N/A
1998-09-22
II
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ARCHIMICA SPA
Inactive
8834
N/A
1990-10-10
II
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EUTICALS SPA
Inactive
25265
N/A
2011-09-07
II
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EUTICALS SPA
Inactive
25394
N/A
2011-10-18
II
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ARCHIMICA SRL
Inactive
16638
N/A
2003-06-06
II
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ARCHIMICA SPA
Active
23704
Complete
2013-07-31
2013-07-18
2010-04-12
II
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ARCHIMICA SPA
Inactive
11596
N/A
1995-07-25
II
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ARCHIMICA SPA
Inactive
10414
N/A
1993-08-09
II
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EUTICALS SPA
Inactive
25393
N/A
2011-10-18
II
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