Dexlansoprazole Sesquihydrate

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ACTIVE PHARMA INGREDIENTS

50 API Suppliers, 22 USDMF, 11 EU WC, 8 KDMF, 18 NDC API, 37 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

7 API Suppliers

7 API Suppliers

FINISHED DOSAGE FORMULATIONS

41 FDF Dossiers, 9 FDA Orange Book, 8 Europe, 6 Canada, 18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE, DELAYED RELEASE;ORAL - 30MG, CAPSULE, DELAYED RELEASE;ORAL - 60MG

RELATED EXCIPIENT COMPANIES

3 Evonik, 1 Rochem International Inc, 5 SPI Pharma, 6 DKSH, 1 Jai Radhe Sales, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 14 Corel Pharma Chem, 1 Finar, 8 Gangwal Chemicals, 12 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 12 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 2 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 2 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 13 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 1 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

61 Coating Systems & Additives, 32 Controlled & Modified Release, 21 Fillers, Diluents & Binders, 15 Solubilizers, 12 Direct Compression, 12 Thickeners and Stabilizers, 11 Film Formers & Plasticizers, 9 Taste Masking, 9 Co-Processed Excipients, 8 Parenteral, 7 Emulsifying Agents, 6 Disintegrants & Superdisintegrants, 5 Rheology Modifiers, 5 Empty Capsules, 5 API Stability Enhancers, 4 Coloring Agents, 4 Chewable & Orodispersible Aids, 4 Lubricants & Glidants, 4 Vegetarian Capsules, 3 Granulation, 3 Topical, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

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GLOBAL SALES INFORMATION

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PATENTS & EXCLUSIVITIES

40 US Patents, 24 Health Canada Patents

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 22287 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 30MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXLANSOPRAZOLE(UNII: UYE4T5I70X) (DEXLANSOPRAZOLE - UNII:UYE4T5I70X)	DEXLANSOPRAZOLE	60mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions
aluminum oxide(LMI26O6933)
carrageenan(5C69YCD2YJ)
FD&C Blue No. 2(L06K8R7DQK)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
low-substituted hydroxypropyl cellulose, unspecified(2165RE0K14)
magnesium carbonate(0E53J927NA)
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A(NX76LV5T8J)
Methacrylic Acid - Methyl Methacrylate Copolymer (1:1)(74G4R6TH13)
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)(5KY68S2577)
polyethylene glycol 8000(Q662QK8M3B)
polysorbate 80(6OZP39ZG8H)
potassium chloride(660YQ98I10)
silicon dioxide(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
sucrose(C151H8M554)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
triethyl citrate(8Z96QXD6UM)

Drug Product Composition: Dexlansoprazole Sesquihydrate