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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Indena

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01 10-Deacetylbaccatin- III (1)

02 Bilberry (1)

03 Boldine (1)

04 Cabazitaxel (1)

05 Cannabidiol (1)

06 Cascara (1)

07 Colchicine (2)

08 Deserpidine (1)

09 Docetaxel (3)

10 Enoxolone (1)

11 Galantamine Hydrobromide (1)

12 Ginkgo Biloba Extract (1)

13 Ingenol Mebutate (1)

14 Paclitaxel (6)

15 Perforate St John wort (1)

16 Reserpine (1)

17 Resiniferatoxin (1)

18 Silybum Marianum L. (1)

19 Thiocolchicoside (5)

20 Thiotepa (1)

21 saw palmetto (2)

22 Blank (3)

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01 Active (14)

02 Inactive (9)

03 Blank (14)

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01 Valid (19)

02 Withdrawn by Holder (1)

03 Blank (17)

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01 218MF10226 (1)

02 218MF10269 (1)

03 221MF10053 (1)

04 226MF10210 (1)

05 301MF10103 (1)

06 Blank (32)

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01 Blank (37)

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USDMF

Found USDMF

10088
Active
COLCHICINE USP
1993-02-10
CEP/COS

Found CEP/COS

R1-CEP 2004-182 - Rev 03
Valid
Colchicine
2021-11-08
Japanese DMF

Found JDMF

218MF10226
Colchicine at Viale Ortles 12 Milan...
2006-02-16
Written Confirmation

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Application Number
10088
218MF10226
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
COLCHICINE USP
Colchicine
Colchicine at Viale Ortles 12 Milan...
Issue/Submission Date
1993-02-10
2021-11-08
2006-02-16
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USDMF

Found USDMF

23884
Active
N-DEBOC-DOCETAXEL (N-DEBENZOYL-10-D...
2010-06-08
CEP/COS

Found CEP/COS

R0-CEP 2018-094 - Rev 01
Valid
Docetaxel trihydrate
2020-08-25
Japanese DMF

Found JDMF

301MF10103
Docetaxel at Viale Ortles 12 Milan ...
2019-12-10
Written Confirmation

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Application Number
23884
301MF10103
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
N-DEBOC-DOCETAXEL (N-DEBENZOYL-10-D...
Docetaxel trihydrate
Docetaxel at Viale Ortles 12 Milan ...
Issue/Submission Date
2010-06-08
2020-08-25
2019-12-10
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USDMF

Found USDMF

16242
Active
PACLITAXEL P.I.
2002-11-13
CEP/COS

Found CEP/COS

R1-CEP 2008-102 - Rev 03
Valid
Paclitaxel, produced by semi-synthe...
2022-10-19
Japanese DMF

Found JDMF

221MF10053
Paclitaxel / S at Viale Ortles 12 M...
2009-03-16
Written Confirmation

Close WC

Application Number
16242
221MF10053
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
PACLITAXEL P.I.
Paclitaxel, produced by semi-synthe...
Paclitaxel / S at Viale Ortles 12 M...
Issue/Submission Date
2002-11-13
2022-10-19
2009-03-16
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USDMF

Caution USDMF

12757
Inactive
PACLITAXEL, DRUG SUBSTANCE
1997-11-20
CEP/COS

Found CEP/COS

R1-CEP 2006-320 - Rev 02
Valid
Paclitaxel, Isolated from natural s...
2020-11-19
Japanese DMF

Found JDMF

218MF10269
Paclitaxel / PI at Viale Ortles 12 ...
2006-05-22
Written Confirmation

Close WC

Application Number
12757
218MF10269
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
PACLITAXEL, DRUG SUBSTANCE
Paclitaxel, Isolated from natural s...
Paclitaxel / PI at Viale Ortles 12 ...
Issue/Submission Date
1997-11-20
2020-11-19
2006-05-22
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USDMF

Caution USDMF

12876
Inactive
PACLITAXEL
1998-02-23
CEP/COS

Found CEP/COS

R0-CEP 2019-346 - Rev 05
Valid
Paclitaxel, Produced by a semi-synt...
2023-07-11
Japanese DMF

Found JDMF

226MF10210
Paclitaxel / S at Viale Ortles 12 M...
2014-10-27
Written Confirmation

Close WC

Application Number
12876
226MF10210
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
PACLITAXEL
Paclitaxel, Produced by a semi-synt...
Paclitaxel / S at Viale Ortles 12 M...
Issue/Submission Date
1998-02-23
2023-07-11
2014-10-27
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USDMF

Found USDMF

23886
Active
DOCETAXEL
2010-08-30
CEP/COS

Found CEP/COS

R1-CEP 2012-216 - Rev 01
Valid
Docetaxel
2020-08-25
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
23886
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DOCETAXEL
Docetaxel
Issue/Submission Date
2010-08-30
2020-08-25
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USDMF

Caution USDMF

22115
Inactive
IDN 5404 (THIOCOLCHICINE DERIVATIVE...
2008-10-29
CEP/COS

Found CEP/COS

R0-CEP 2021-118 - Rev 00
Valid
Colchicine, Micronised
2021-08-13
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
22115
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
IDN 5404 (THIOCOLCHICINE DERIVATIVE...
Colchicine, Micronised
Issue/Submission Date
2008-10-29
2021-08-13
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USDMF

Found USDMF

20977
Active
PACLITAXEL/S
2007-10-22
CEP/COS

Caution CEP/COS

R1-CEP 2006-319 - Rev 00
Withdrawn by Holder
Paclitaxel, isolated from natural s...
2013-03-26
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
20977
Status
Active
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
PACLITAXEL/S
Paclitaxel, isolated from natural s...
Issue/Submission Date
2007-10-22
2013-03-26
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USDMF

Found USDMF

10462
Active
10-DEACETYLBACCATIN III/R
1993-08-25
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

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Application Number
10462
Status
Active
Fees Paid
N/A
 
Filing Details
10-DEACETYLBACCATIN III/R
Issue/Submission Date
1993-08-25
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2009-158 - Rev 01
Valid
Fresh bilberry fruit dry extract, r...
2020-11-19
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Fresh bilberry fruit dry extract, r...
Issue/Submission Date
2020-11-19
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