Prestwick3_000958

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

66 API Suppliers, 22 USDMF, 21 CEP/COS, 12 JDMF, 3 EU WC, 14 KDMF, 18 NDC API, 34 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

210 FDF Dossiers, 34 FDA Orange Book, 115 Europe, 11 Canada, 5 Australia, 2 South Africa, 43 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 300MG, TABLET;ORAL - 250MG, TABLET;ORAL - 500MG

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 11 DKSH, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 4 Actylis, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 29 BASF, 2 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 29 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 26 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 37 Direct Compression, 32 Thickeners and Stabilizers, 32 Controlled & Modified Release, 26 Granulation, 25 Film Formers & Plasticizers, 21 Disintegrants & Superdisintegrants, 20 Topical, 20 Solubilizers, 18 Co-Processed Excipients, 18 Taste Masking, 16 Lubricants & Glidants, 12 Parenteral, 9 Chewable & Orodispersible Aids, 9 Empty Capsules, 6 Rheology Modifiers, 5 Emulsifying Agents, 5 API Stability Enhancers, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 40 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 107 Finished Drug Prices, 2 Annual Reports

MARKET PLACE

29 APIs, 12 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 1 USP, 8 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 19594 / DOSAGE - CAPSULE;ORAL - 300MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
URSODIOL(UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR)	URSODIOL	300mg

Inactive Ingredients

Ingredient Name	Major Pharmaceuticals	Golden State Medical Supply, Inc.	NCS HealthCare of KY, Inc dba Vangard Labs	Avera McKennan Hospital	AvKARE, Inc.	AvPAK	Cardinal Health 107, LLC	Mylan Institutional Inc.	Mylan Pharmaceuticals Inc.	A-S Medication Solutions	Preferred Pharmaceuticals Inc.	American Health Packaging	Cardinal Health
ALCOHOL(3K9958V90M)
ALUMINUM OXIDE(LMI26O6933)
BUTYL ALCOHOL(8PJ61P6TS3)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)
D&C RED NO. 28(767IP0Y5NH)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
MAGNESIUM STEARATE(70097M6I30)
METHYL ALCOHOL(Y4S76JWI15)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Prestwick3_000958