Ursodeoxycholic Acid

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ACTIVE PHARMA INGREDIENTS

70 API Suppliers, 23 USDMF, 22 CEP/COS, 13 JDMF, 3 EU WC, 14 KDMF, 17 NDC API, 35 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

215 FDF Dossiers, 34 FDA Orange Book, 115 Europe, 11 Canada, 5 Australia, 2 South Africa, 48 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, 5 Faran Shimi Pharmaceutical, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 4 Actylis, 1 Alcedo Pharmachem, 6 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 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 36 Direct Compression, 32 Thickeners and Stabilizers, 32 Controlled & Modified Release, 26 Granulation, 25 Film Formers & Plasticizers, 20 Disintegrants & Superdisintegrants, 20 Topical, 19 Solubilizers, 18 Co-Processed Excipients, 18 Taste Masking, 16 Lubricants & Glidants, 12 Parenteral, 9 Empty Capsules, 9 Chewable & Orodispersible Aids, 6 Rheology Modifiers, 5 API Stability Enhancers, 5 Coloring Agents, 5 Emulsifying Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

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2 DATA COMPILATION #PharmaFlow, 41 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 - 20675 / DOSAGE - TABLET;ORAL - 250MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ursodiol(UNII: 724L30Y2QR) (ursodiol - UNII:724L30Y2QR)	ursodiol	250mg \| 500mg

Inactive Ingredients

Ingredient Name	Cardinal Health	Actavis Pharma, Inc.	American Health Packaging	Avera McKennan Hospital	BluePoint Laboratories	Impax Generics	Lake Erie Medical DBA Quality Care Products LLC	Strides Pharma Science Limited
CARNAUBA WAX(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
cetyl alcohol(936JST6JCN)
COPOVIDONE K25-31(D9C330MD8B)
dibutyl sebacate(4W5IH7FLNY)
ETHYLCELLULOSES(7Z8S9VYZ4B)
hydrogen peroxide(BBX060AN9V)
HYPROMELLOSE 2910 (15000 MPA.S)(288VBX44JC)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MEDIUM-CHAIN TRIGLYCERIDES(C9H2L21V7U)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POVIDONE K29/32(390RMW2PEQ)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium lauryl sulfate(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TITANIUM DIOXIDE(15FIX9V2JP)
TROMETHAMINE(023C2WHX2V)

Drug Product Composition: Ursodeoxycholic Acid