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

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01 2,3 DI-O-BENZYL 4,6-O-ETHYLIDENE-D-GLUCOPYRANOSIDE (DBEG) (1)

02 D-(-)-TAGATOSE (1)

03 GOS 95 (1)

04 LACTITOL MONOHYDRATE (1)

05 LACTULOSE 50% SYRUP (1)

06 LACTULOSE CRYSTALS (2)

07 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN PISTOIA, ITALY (1)

08 MANUFACTURING SITES, FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT R S M S.R.L. IN PISTOIA, ITALY (1)

09 PURIFIED LACTULOSE SYRUP (1)

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01 INALCO SAS DI GIOVANNI CIPOLLETTI AND C (2)

02 INALCO SPA (6)

03 INALCO SRL (2)

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01 Italy (10)

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01 Active (4)

02 Inactive (6)

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01 Blank (10)

URL Supplier Web Content
INALCO SAS DI GIOVANN...
Active
22715
N/A
2009-04-07
II
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INALCO SRL
Active
27765
N/A
2013-11-21
II
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INALCO SAS DI GIOVANN...
Active
5412
N/A
1984-02-07
II
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INALCO SPA
Inactive
9537
N/A
1992-01-30
II
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INALCO SPA
Inactive
11262
N/A
1994-12-25
II
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INALCO SPA
Inactive
7682
N/A
1988-09-20
II
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2,3 DI-O-BENZYL 4,6-O-ETHYLIDENE-D-...

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INALCO SPA
Inactive
12200
N/A
1996-10-30
II
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GOS 95

URL Supplier Web Content
INALCO SRL
Active
23206
N/A
2009-10-20
II
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MANUFACTURING SITE, FACILITIES, PER...

URL Supplier Web Content
INALCO SPA
Inactive
11261
N/A
1994-11-25
II
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MANUFACTURING SITES, FACILITIES, PE...

URL Supplier Web Content
INALCO SPA
Inactive
12199
N/A
1996-10-30
II
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