Rabeprazole Sodium

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ACTIVE PHARMA INGREDIENTS

102 API Suppliers, 30 USDMF, 15 CEP/COS, 18 JDMF, 20 EU WC, 15 KDMF, 10 NDC API, 53 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

30 Drugs in Development

30 Drugs in Development

INTERMEDIATES

23 Intermediate Suppliers

23 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

376 FDF Dossiers, 15 FDA Orange Book, 148 Europe, 10 Canada, 73 Australia, 11 South Africa, 119 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - 10MG, CAPSULE, DELAYED RELEASE;ORAL - 5MG, TABLET, DELAYED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 20MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 2 Rochem International Inc, 19 SPI Pharma, 9 DKSH, 5 Boai NKY Pharmaceuticals Ltd, 7 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 4 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 1 Avesta Pharma, 37 BASF, 1 CD Formulation, 1 Clariant, 14 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 3 Finar, 13 Gangwal Chemicals, 10 Ideal Cures, 3 Ingredion Pharma Solutions, 23 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

70 Coating Systems & Additives, 67 Fillers, Diluents & Binders, 43 Disintegrants & Superdisintegrants, 38 Controlled & Modified Release, 36 Granulation, 35 Direct Compression, 34 Solubilizers, 31 Thickeners and Stabilizers, 26 Lubricants & Glidants, 21 Parenteral, 21 Taste Masking, 21 Topical, 20 Chewable & Orodispersible Aids, 20 Film Formers & Plasticizers, 14 Emulsifying Agents, 11 Co-Processed Excipients, 9 Rheology Modifiers, 6 Surfactant & Foaming Agents, 6 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

13 News #PharmaBuzz

13 News #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 71 Regulatory FDF Prices, 13 Annual Reports

MARKET PLACE

53 APIs, 10 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

4 Health Canada Patents

4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 2 JP, 23 Others

ANALYTICAL

1 BioAnalytical Methods, 2 Analytical Methods

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USFDA APPLICATION NUMBER - 20973 / DOSAGE - TABLET, DELAYED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RABEPRAZOLE SODIUM(UNII: 3L36P16U4R) (RABEPRAZOLE - UNII:32828355LL)	RABEPRAZOLE SODIUM	20mg

Inactive Ingredients

Ingredient Name	Bryant Ranch Prepack	Cardinal Health	Lake Erie Medical & Surgical Supplies DBA Quality Care Products LLC	Lake Erie Medical DBA Quality Care Produtcs LLC
CARNAUBA WAX(R12CBM0EIZ)
CROSPOVIDONE(2S7830E561)
CROSPOVIDONE(68401960MK)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
PROPYLENE GLYCOL(6DC9Q167V3)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Rabeprazole Sodium