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List of Drug Master Files (DMF) of Excipients submissions by Roquette to the U.S. FDA. Original Data : FDA Website

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01 BETA CYCLODEXTRIN (1)

02 CROSCARMELLOSE SODIUM (CRESTCROSS) (1)

03 DIBASIC CALCIUM PHOSPHATE (CRESTADD) (1)

04 EXPLOTAB BRAND OF SODIUM STARCH GLYCOLATE (1)

05 GLYCOLYS@SODIUM STARCH GLYCOLATE NF (1)

06 GLYCOLYS® SODIUM STARCH GLYCOLATE USP/NF (1)

07 HYDROXY-PROPYL BETA-CYCLODEXTRIN (1)

08 LYCASIN BRAND HYDROGENATED GLUCOSE SYRUP(LYCASIN HGS (1)

09 LYCASIN BRAND OF HYDROGENATED GLUCOSE SYRUP (1)

10 MAGNESIUM STEARATE (LUBRICREST) (1)

11 MALTODEXTRIN FOR PERITONEAL DIALYSIS (1)

12 MANNITOL USP POWDER PEARLITOL ® (1)

13 MANNITOL, SPRAY DRIED (1)

14 MICROCEL MICROCRYSTALLINE CELLULOSE (1)

15 MICROCRYSTALLINE CELLULOSE (CELLUCREST) (1)

16 NEOSORB 70/20 SORBITOL SOLUTION (1)

17 PEA STARCH HYDROXYPROPYL (LYCOAT r NG) (1)

18 PEARLITOL FLASH (1)

19 POLYSORB 85/70/00 (SORBITOL SORBITAN SOLUTION) (1)

20 PREGELATINIZED HYDROXYPROPYL PEA STARCH (LYCOAT ® RS) (1)

21 PREGELATINIZED MAIZE STARCH (GELMAC) (1)

22 SODIUM STARCH GLYCOLATE (RAPIGEL) (1)

23 SOLUTAB CROSCARMELLOSE SODIUM (1)

24 TABULOSE SC, MICROCRYSTALLINE CELLULOSE AND CARBOXYMETHYLCELLULOSE SODIUM (1)

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01 CREST CELLULOSE PRIVATE LIMITED (4)

02 CREST CELLULOSE PRIVATE LTD (2)

03 ITACEL FARMOQUIMICA LTDA (4)

04 ROQUETTE AMERICA INC (1)

05 ROQUETTE CORPORATION (1)

06 ROQUETTE FRERES (11)

07 ROQUETTE NATIONAL CHIMIE OF LILLE (1)

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01 Brazil (1)

02 France (22)

03 U.S.A (1)

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01 Active (19)

02 Inactive (5)

URL Supplier Web Content
ROQUETTE FRERES
Active
IV
9155
1991-06-10
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CREST CELLULOSE PRIVATE...
Active
IV
32790
2018-04-27
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CREST CELLULOSE PRIVATE...
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IV
31776
2017-05-19
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ROQUETTE NATIONAL CHIMI...
Inactive
II
3495
1979-03-16
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ITACEL FARMOQUIMICA LTD...
Active
IV
7651
1988-08-22
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ROQUETTE FRERES
Active
IV
16854
2003-09-23
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ROQUETTE FRERES
Active
IV
9420
1991-11-22
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ROQUETTE FRERES
Inactive
IV
5656
1984-11-05
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ROQUETTE CORPORATION
Inactive
IV
6611
1986-10-02
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CREST CELLULOSE PRIVATE...
Active
IV
32441
2018-01-08
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