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

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01 10-DEACETYLBACCATIN III/R (1)

02 CABAZITAXEL (1)

03 CANNABIDIOL (1)

04 CASANTHRANOL (THIS D FORMERLY HELD BY INVERNI DELLA BEFFA, ITALY) (1)

05 COLCHICINE USP (1)

06 DESERPIDINE USP (1)

07 DOCETAXEL (1)

08 DOCETAXEL TRIHYDRATE (1)

09 FACILITY AND OPERATING PROCEDURES IN SETTALA (MI), ITALY (1)

10 IDN 5109 (1)

11 IDN 5404 (THIOCOLCHICINE DERIVATIVE) (1)

12 INGENOL MEBUTATE (1)

13 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SETTALA PLANT. (1)

14 N-DEBOC-DOCETAXEL (N-DEBENZOYL-10-DEACETYLPACLITAXEL INTERMEDIATE) (1)

15 PACLITAXEL (1)

16 PACLITAXEL P.I. (1)

17 PACLITAXEL, DRUG SUBSTANCE (1)

18 PACLITAXEL/S (1)

19 PACLITAXEL/S SEMISYNTHETIC PROCESS, USP/EP (1)

20 PACLITAXEL/SW (1)

21 RESERPINE USP (1)

22 RESINIFERATOXIN (1)

23 THIOTEPA (1)

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01 INDENA GRUPPO INVERNI DELLA BEFFA (3)

02 INDENA INDUSTRIA DERIVATI NATURALI (1)

03 INDENA SPA (18)

04 INDENA UK LTD (1)

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01 Italy (23)

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01 Active (14)

02 Inactive (9)

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01 Complete (8)

02 Blank (15)

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INDENA SPA
Active
10462
N/A
1993-08-25
II
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INDENA SPA
Active
34809
Complete
2021-09-16
2020-12-10
2020-04-17
II
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INDENA SPA
Active
35648
Complete
2022-01-03
2021-06-01
2021-02-16
II
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INDENA GRUPPO INVERNI...
Inactive
3085
N/A
1977-11-21
II
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INDENA SPA
Active
10088
Complete
2013-03-07
2013-02-25
1993-02-10
II
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INDENA GRUPPO INVERNI...
Inactive
4808
N/A
1983-02-18
II
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INDENA SPA
Active
23886
Complete
2018-09-03
2018-05-18
2010-08-30
II
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INDENA SPA
Active
33209
Complete
2019-04-12
2018-09-26
2018-09-28
II
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INDENA SPA
Inactive
22115
N/A
2008-10-29
II
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INDENA SPA
Inactive
28747
N/A
2014-12-22
II
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