Dabigatran Etexilate Mesylate

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ACTIVE PHARMA INGREDIENTS

94 API Suppliers, 36 USDMF, 20 EU WC, 18 KDMF, 22 NDC API, 74 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

125 Intermediates Suppliers

125 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

162 FDF Dossiers, 37 FDA Orange Book, 49 Europe, 6 Canada, 26 Australia, 5 South Africa, 39 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 110MG BASE, CAPSULE;ORAL - EQ 150MG BASE, CAPSULE;ORAL - EQ 75MG BASE

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 2 SPI Pharma, 6 DKSH, 1 Faran Shimi Pharmaceutical, 1 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Aeon Procare, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 10 Corel Pharma Chem, 2 Finar, 3 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 12 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 2 Microlex e.U, 1 Novo Excipients, 1 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 3 Roquette, 7 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Coating Systems & Additives, 19 Controlled & Modified Release, 9 Film Formers & Plasticizers, 6 Thickeners and Stabilizers, 5 Empty Capsules, 5 Coloring Agents, 4 Rheology Modifiers, 4 Vegetarian Capsules, 4 Fillers, Diluents & Binders, 4 API Stability Enhancers, 4 Solubilizers, 4 Emulsifying Agents, 3 Parenteral, 3 Direct Compression, 3 Topical, 2 Lubricants & Glidants, 2 Granulation, 2 Taste Masking, 1 Chewable & Orodispersible Aids, 1 Co-Processed Excipients, 1 Soft Gelatin, 1 Disintegrants & Superdisintegrants

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 77 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 48 Finished Drug Prices, 8 Annual Reports

MARKET PLACE

16 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

24 US Patents, 18 US Exclusivities

REF. STANDARDS & IMPURITIES

8 Others

8 Others

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USFDA APPLICATION NUMBER - 22512 / DOSAGE - CAPSULE;ORAL - EQ 150MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DABIGATRAN ETEXILATE MESYLATE(UNII: SC7NUW5IIT) (DABIGATRAN - UNII:I0VM4M70GC)	DABIGATRAN	150mg

Inactive Ingredients

Ingredient Name	Ascend Laboratories, LLC
AMMONIA(5138Q19F1X)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
FERROSOFERRIC OXIDE(XM0M87F357)
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(87Y6436BKR)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(NX76LV5T8J)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 600(NL4J9F21N9)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
POTASSIUM HYDROXIDE(WZH3C48M4T)
POVIDONE K25(K0KQV10C35)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SODIUM BICARBONATE(8MDF5V39QO)
TALC(7SEV7J4R1U)
TARTARIC ACID(W4888I119H)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Dabigatran Etexilate Mesylate