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CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID, TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID, TABLET,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 - 19680 / DOSAGE - CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIVALPROEX SODIUM(UNII: 644VL95AO6) (VALPROIC ACID - UNII:614OI1Z5WI)	VALPROIC ACID	125mg

Inactive Ingredients

Ingredient Name	Mylan Institutional Inc.	Mylan Pharmaceuticals Inc.	American Health Packaging	Cardinal Health	McKesson Contract Packaging	NCS HealthCare of KY, Inc dba Vangard Labs	Sandoz Inc.
AMMONIA(5138Q19F1X)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COPOVIDONE K25-31(D9C330MD8B)
COPOVIDONE(D9C330MD8B)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C RED NO. 28(767IP0Y5NH)
DIBUTYL SEBACATE(4W5IH7FLNY)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MALTODEXTRIN(7CVR7L4A2D)
MANNITOL(3OWL53L36A)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
OLEIC ACID(2UMI9U37CP)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POTASSIUM HYDROXIDE(WZH3C48M4T)
PROPYLENE GLYCOL(6DC9Q167V3)
RAW SUGAR(8M707QY5GH)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM HYDROXIDE(55X04QC32I)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)

Drug Product Composition: Divalproex Sodium