Rizatriptan

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ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 21 USDMF, 13 CEP/COS, 4 JDMF, 15 EU WC, 13 NDC API, 23 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

30 Drugs in Development

30 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

343 FDF Dossiers, 55 FDA Orange Book, 196 Europe, 41 Canada, 7 Australia, 17 South Africa, 27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, ORALLY DISINTEGRATING;ORAL - EQ 10MG BASE, TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 6 Rochem International Inc, 19 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 2 Kirsch Pharma, 4 ACG Worldwide, 3 Actylis, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 6 BASF, 1 Bioplus Life Sciences, 11 Corel Pharma Chem, 6 DFE Pharma, 9 Gangwal Chemicals, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 20 Kerry, 4 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 4 Pharmatrans-Sanaq, 6 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 Silverline Chemicals, 1 Symrise, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

71 Fillers, Diluents & Binders, 46 Disintegrants & Superdisintegrants, 42 Coating Systems & Additives, 34 Direct Compression, 28 Taste Masking, 26 Granulation, 24 Chewable & Orodispersible Aids, 22 Thickeners and Stabilizers, 17 Controlled & Modified Release, 17 Lubricants & Glidants, 16 Film Formers & Plasticizers, 12 Co-Processed Excipients, 11 Parenteral, 9 Empty Capsules, 5 Solubilizers, 5 Rheology Modifiers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Topical, 2 Coloring Agents, 1 Soft Gelatin

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USFDA APPLICATION NUMBER - 205394 / DOSAGE - FILM;ORAL - EQ 10MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RIZATRIPTAN BENZOATE(UNII: WR978S7QHH) (RIZATRIPTAN - UNII:51086HBW8G)	RIZATRIPTAN	5mg \| 10mg

Inactive Ingredients

Ingredient Name	RedHill Biopharma Ltd.
AMMONIUM GLYCYRRHIZATE(3VRD35U26C)
COPOVIDONE(D9C330MD8B)
HYDROXYPROPYL CELLULOSE (TYPE L)(UKE75GEA7F)
MENTHOL(L7T10EIP3A)
SUCRALOSE(96K6UQ3ZD4)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Setid Cd626f6c 3d8e 4a2d A7b3 9fcef12baa7f Applno 205394 Form Film Oral Dosage Eq 10mg Base - Drug Product Composition: Rizatriptan

Rizatriptan

Rizatriptan

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

37 API Suppliers

21 USDMF

13 CEP/COS

4 JDMF

15 EU WC

13 NDC API

23 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

30 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

343 FDF Dossiers

55 FDA Orange Book

196 Europe

41 Canada

7 Australia

17 South Africa

27 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, ORALLY DISINTEGRATING;ORAL - EQ 10MG BASE

TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Evonik

6 Rochem International Inc

19 SPI Pharma

7 DKSH

1 Pharm-RX Chemical

4 Boai NKY Pharmaceuticals Ltd

10 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

1 Pfanstiehl

2 Kirsch Pharma

4 ACG Worldwide

3 Actylis

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

1 Ashland

6 BASF

1 Bioplus Life Sciences

11 Corel Pharma Chem

6 DFE Pharma

9 Gangwal Chemicals

4 Ideal Cures

5 Ingredion Pharma Solutions

20 Kerry

4 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

3 Nitika Pharmaceutical Specialities

2 Novo Excipients

4 Pharmatrans-Sanaq

6 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

29 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

4 Silverline Chemicals

1 Symrise

3 The Dow Chemical Company

1 Ulanqab Kema New Material

TABLET;ORAL - EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, ORALLY DISINTEGRATING;ORAL - EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons