Valproic Acid

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ACTIVE PHARMA INGREDIENTS

68 API Suppliers, 36 USDMF, 10 CEP/COS, 3 JDMF, 8 EU WC, 9 KDMF, 15 NDC API, 35 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

264 FDF Dossiers, 109 FDA Orange Book, 57 Europe, 17 Canada, 30 Australia, 17 South Africa, 34 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CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID, TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID, TABLET,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, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 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, 11 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, 3 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

109 Fillers, Diluents & Binders, 84 Coating Systems & Additives, 53 Direct Compression, 51 Controlled & Modified Release, 44 Disintegrants & Superdisintegrants, 42 Thickeners and Stabilizers, 40 Solubilizers, 35 Granulation, 33 Taste Masking, 28 Film Formers & Plasticizers, 26 Topical, 23 Parenteral, 23 Lubricants & Glidants, 20 Co-Processed Excipients, 18 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 10 API Stability Enhancers, 10 Rheology Modifiers, 9 Empty Capsules, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

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1 DATA COMPILATION #PharmaFlow, 60 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

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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: Valproic Acid

Valproic Acid

Valproic Acid

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ACTIVE PHARMA INGREDIENTS

68 API Suppliers

36 USDMF

10 CEP/COS

3 JDMF

8 EU WC

9 KDMF

15 NDC API

35 Listed Suppliers

$ API Reference Price

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

FINISHED DOSAGE FORMULATIONS

264 FDF Dossiers

109 FDA Orange Book

57 Europe

17 Canada

30 Australia

17 South Africa

34 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

2 Jai Radhe Sales

1 Pharm-RX Chemical

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

11 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

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