Rabeprazole Sodium

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ACTIVE PHARMA INGREDIENTS

95 API Suppliers, 31 USDMF, 15 CEP/COS, 19 JDMF, 23 EU WC, 12 KDMF, 12 NDC API, 50 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

19 API Suppliers

19 API Suppliers

FINISHED DOSAGE FORMULATIONS

319 FDF Dossiers, 15 FDA Orange Book, 145 Europe, 12 Canada, 36 Australia, 11 South Africa, 100 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- 5MG, TABLET, DELAYED RELEASE;ORAL - 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 20MG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, 1 Evonik, 2 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 7 DKSH, 3 Jai Radhe Sales, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 37 BASF, 1 Clariant, 14 Corel Pharma Chem, 6 DFE Pharma, 3 Finar, 13 Gangwal Chemicals, 12 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 34 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 7 Pluviaendo, 5 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, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

80 Fillers, Diluents & Binders, 74 Coating Systems & Additives, 45 Controlled & Modified Release, 45 Direct Compression, 42 Disintegrants & Superdisintegrants, 34 Solubilizers, 33 Granulation, 31 Thickeners and Stabilizers, 26 Lubricants & Glidants, 22 Parenteral, 20 Film Formers & Plasticizers, 20 Taste Masking, 20 Topical, 18 Chewable & Orodispersible Aids, 16 Co-Processed Excipients, 12 Emulsifying Agents, 7 Rheology Modifiers, 7 API Stability Enhancers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 139 Finished Drug Prices, 12 Annual Reports

MARKET PLACE

47 APIs, 10 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 USP, 2 JP, 15 Others

ANALYTICAL

1 BioAnalytical Methods, 2 Analytical Methods

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USFDA APPLICATION NUMBER - 204736 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 10MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RABEPRAZOLE SODIUM(UNII: 3L36P16U4R) (RABEPRAZOLE - UNII:32828355LL)	RABEPRAZOLE SODIUM	10mg \| 5mg

Inactive Ingredients

Ingredient Name	Avadel Pharmaceuticals (USA), Inc.	Aytu Therapeutics, LLC
ALUMINUM OXIDE(LMI26O6933)
CARRAGEENAN(5C69YCD2YJ)
DIACETYLATED MONOGLYCERIDES(5Z17386USF)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C YELLOW NO. 6(H77VEI93A8)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)
MAGNESIUM OXIDE(3A3U0GI71G)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
POTASSIUM CHLORIDE(660YQ98I10)
SILICON DIOXIDE(ETJ7Z6XBU4)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Rabeprazole Sodium