Phenytoin Sodium

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ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 12 USDMF, 2 CEP/COS, 4 EU WC, 9 NDC API, 13 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

71 FDF Dossiers, 38 FDA Orange Book, 2 Europe, 6 Canada, 2 South Africa, 23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 50MG/ML, CAPSULE;ORAL - 100MG EXTENDED, CAPSULE;ORAL - 30MG EXTENDED

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 11 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 16 BASF, 10 Corel Pharma Chem, 4 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 12 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 48 Coating Systems & Additives, 33 Direct Compression, 25 Controlled & Modified Release, 24 Thickeners and Stabilizers, 21 Granulation, 15 Taste Masking, 15 Lubricants & Glidants, 15 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 11 Solubilizers, 11 Parenteral, 10 Film Formers & Plasticizers, 9 Topical, 9 Empty Capsules, 8 Disintegrants & Superdisintegrants, 5 API Stability Enhancers, 5 Coloring Agents, 5 Emulsifying Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 1 Surfactant & Foaming Agents

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1 DATA COMPILATION #PharmaFlow, 13 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 8 Finished Drug Prices

MARKET PLACE

9 APIs, 3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 2 USP, 2 Others

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USFDA APPLICATION NUMBER - 84349 / DOSAGE - CAPSULE;ORAL - 30MG EXTENDED

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PHENYTOIN SODIUM(UNII: 4182431BJH) (PHENYTOIN - UNII:6158TKW0C5)	PHENYTOIN SODIUM	30mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions LLC	Cardinal Health	Lake Erie Medical DBA Quality Care Products LLC	REMEDYREPACK INC.	KAISER FOUNDATION HOSPITALS
D&C RED NO. 28(767IP0Y5NH)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C RED NO. 3(PN2ZH5LOQY)
FD&C YELLOW NO. 6(H77VEI93A8)
GELATIN(2G86QN327L)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Phenytoin Sodium