Divalproex Sodium

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ACTIVE PHARMA INGREDIENTS

67 API Suppliers, 36 USDMF, 10 CEP/COS, 3 JDMF, 8 EU WC, 9 KDMF, 15 NDC API, 34 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

266 FDF Dossiers, 109 FDA Orange Book, 57 Europe, 17 Canada, 30 Australia, 17 South Africa, 36 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID, TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID, TABLET, DELAYED RELEASE;ORAL - EQ 500MG VALPROIC ACID, CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID, TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID, TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID

RELATED EXCIPIENT COMPANIES

3 Evonik, 3 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 14 DKSH, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 11 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 38 BASF, 2 Clariant, 18 Corel Pharma Chem, 6 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 16 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 34 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 5 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 27 Roquette, 14 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

108 Fillers, Diluents & Binders, 84 Coating Systems & Additives, 52 Direct Compression, 51 Controlled & Modified Release, 43 Disintegrants & Superdisintegrants, 42 Thickeners and Stabilizers, 39 Solubilizers, 35 Granulation, 33 Taste Masking, 28 Film Formers & Plasticizers, 26 Topical, 23 Parenteral, 23 Lubricants & Glidants, 21 Co-Processed Excipients, 18 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 10 Rheology Modifiers, 10 API Stability Enhancers, 9 Empty Capsules, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 60 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 91 Finished Drug Prices, 5 Annual Reports

MARKET PLACE

25 APIs, 16 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 3 USP, 4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21168 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIVALPROEX SODIUM(UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)	VALPROIC ACID	500mg

Inactive Ingredients

Ingredient Name	Cardinal Health	McKesson Contract Packaging	NCS HealthCare of KY, Inc dba Vangard Labs	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	Impax Generics	ATLANTIC BIOLOGICALS CORP.	AvPAK	Direct_Rx	Lupin Pharmaceuticals, Inc.	Major Pharmaceuticals	PD-Rx Pharmaceuticals, Inc.	Safecor Health, LLC	Wockhardt USA LLC.	Zydus Pharmaceuticals USA Inc	A-S Medication Solutions	Bryant Ranch Prepack	Preferred Pharmaceuticals, Inc.	REMEDYREPACK INC.	Avera McKennan Hospital	Par Pharmaceutical, Inc.	BluePoint Laboratories
AMMONIA(5138Q19F1X)
AMMONIUM LAURETH-5 SULFATE(43ZIH89I48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
BUTYL ALCOHOL(8PJ61P6TS3)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COPOVIDONE K25-31(D9C330MD8B)
COPOVIDONE(D9C330MD8B)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(O7TSZ97GEP)
DIBUTYL SEBACATE(4W5IH7FLNY)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(P2OM2Q86BI)
ETHYL ACRYLATE(71E6178C9T)
ETHYLCELLULOSE (10 MPA.S)(3DYK7UYZ62)
ETHYLCELLULOSE (7 MPA.S)(H3UP11403C)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GLYCERYL DIBEHENATE(R8WTH25YS2)
HYDROGENATED COTTONSEED OIL(Z82Y2C65EA)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(R33S7TK2EP)
hydroxyethyl cellulose (2000 CPS AT 1%)(S38J6RZN16)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)(S38J6RZN16)
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%)(ZYD53NBL45)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)(ZYD53NBL45)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYPROMELLOSE 2208 (100 MPA.S)(B1QE5P712K)
HYPROMELLOSE 2208 (100000 MPA.S)(VM7F0B23ZI)
Hypromellose 2208 (15000 Mpa.S)(Z78RG6M2N2)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
ISOPROPYL ALCOHOL(ND2M416302)
lactose monohydrate(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
OLEIC ACID(2UMI9U37CP)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 1000000(HZ58M6D839)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POTASSIUM SORBATE(1VPU26JZZ4)
POVIDONE K12(333AG72FWJ)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
silicon dioxide (ETJ7Z6XBU4)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Divalproex Sodium