Ursodeoxycholic Acid

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

99 API Suppliers, 26 USDMF, 24 CEP/COS, 12 JDMF, 4 EU WC, 18 KDMF, 18 NDC API, 41 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

40 Drugs in Development

40 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

242 FDF Dossiers, 34 FDA Orange Book, 144 Europe, 12 Canada, 6 Australia, 2 South Africa, 44 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 6 SPI Pharma, 13 DKSH, 1 Pharm-RX Chemical, 6 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 4 Actylis, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 29 BASF, 1 CD Formulation, 2 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 2 Esteem Industries, 2 Finar, 8 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 19 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 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, 9 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

64 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 33 Thickeners and Stabilizers, 29 Granulation, 27 Direct Compression, 27 Controlled & Modified Release, 23 Film Formers & Plasticizers, 21 Topical, 20 Solubilizers, 18 Taste Masking, 18 Disintegrants & Superdisintegrants, 15 Lubricants & Glidants, 14 Co-Processed Excipients, 10 Chewable & Orodispersible Aids, 10 Parenteral, 9 Rheology Modifiers, 9 Empty Capsules, 6 Emulsifying Agents, 5 Coloring Agents, 5 API Stability Enhancers, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

DIGITAL CONTENT

3 Data Compilation #PharmaFlow, 44 News #PharmaBuzz

GLOBAL SALES INFORMATION

24 US Medicaid Prescriptions, 91 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

35 APIs, 13 FDF Dossiers

REF. STANDARDS & IMPURITIES

4 EDQM, 8 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls

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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)

Setid 90593214 5e4d 4b91 B308 A82311a3e4f9 Applno 20675 Form Tablet Oral Dosage 250mg - Drug Product Composition: Ursodeoxycholic Acid