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

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01 Beta-Cyclodextrin (1)

02 Beta-Cyclodextrin API (1)

03 Carboxymethyl Cellulose Sodium (1)

04 Carboxymethyl Ether (2)

05 Corn Starch (1)

06 Croscarmellose Sodium (1)

07 Dextrose Monohydrate (1)

08 Dibasic Calcium Phosphate (1)

09 Hydroxypropyl Betacyclodextrin (1)

10 Hydroxypropyl Starch Ether (1)

11 Magnesium Stearate (1)

12 Maltodextrin (1)

13 Mannitol (3)

14 Microcrystalline Cellulose (3)

15 Pea Starch (1)

16 Sodium Carboxymethylcellulose (1)

17 Sodium Starch Glycolate (1)

18 Sorbitol (2)

19 Sorbitol API (3)

20 Blank (1)

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01 Active (19)

02 Inactive (5)

03 Blank (4)

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01 Valid (6)

02 Blank (22)

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01 222MF10150 (1)

02 222MF10152 (1)

03 Blank (26)

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01 Blank (28)

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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 1996-030 - Rev 04
Valid
Glucose monohydrate, for use in the...
2015-12-21
Japanese DMF

Found JDMF

222MF10150
LYCADEX PF at La Haute Loge LESTREM...
2010-05-17
Written Confirmation

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Application Number
R1-CEP 1996-030 - Rev 04
222MF10150
Status
Valid
 
Filing Details
Glucose monohydrate, for use in the...
LYCADEX PF at La Haute Loge LESTREM...
Issue/Submission Date
2015-12-21
2010-05-17
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USDMF

Found USDMF

14891
Active
MANNITOL, SPRAY DRIED
2000-05-16
CEP/COS

Found CEP/COS

R1-CEP 2000-039 - Rev 01
Valid
Mannitol
2019-09-12
Japanese DMF

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Written Confirmation

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Application Number
14891
R1-CEP 2000-039 - Rev 01
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
MANNITOL, SPRAY DRIED
Mannitol
Issue/Submission Date
2000-05-16
2019-09-12
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USDMF

Found USDMF

18143
Active
MANNITOL USP POWDER PEARLITOL ®
2005-03-08
CEP/COS

Found CEP/COS

R1-CEP 2000-040 - Rev 02
Valid
Mannitol, Spray dried
2019-09-12
Japanese DMF

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Written Confirmation

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Application Number
18143
R1-CEP 2000-040 - Rev 02
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
MANNITOL USP POWDER PEARLITOL ®
Mannitol, Spray dried
Issue/Submission Date
2005-03-08
2019-09-12
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USDMF

Found USDMF

6244
Active
POLYSORB 85/70/00 (SORBITOL SORBITA...
1986-04-03
CEP/COS

Found CEP/COS

R1-CEP 2001-113 - Rev 02
Valid
Sorbitol
2019-12-05
Japanese DMF

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Written Confirmation

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Application Number
6244
R1-CEP 2001-113 - Rev 02
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
POLYSORB 85/70/00 (SORBITOL SORBITA...
Sorbitol
Issue/Submission Date
1986-04-03
2019-12-05
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USDMF

Found USDMF

16854
Active
GLYCOLYS® SODIUM STARCH GLYCOLATE ...
2003-09-23
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
16854
Status
Active
Fees Paid
N/A
 
Filing Details
GLYCOLYS® SODIUM STARCH GLYCOLATE ...
Issue/Submission Date
2003-09-23
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USDMF

Found USDMF

23919
Active
PEA STARCH HYDROXYPROPYL (LYCOAT r ...
2010-06-25
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
23919
Status
Active
Fees Paid
N/A
 
Filing Details
PEA STARCH HYDROXYPROPYL (LYCOAT r ...
Issue/Submission Date
2010-06-25
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USDMF

Found USDMF

23720
Active
PEARLITOL FLASH
2010-04-16
CEP/COS

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Japanese DMF

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