Dexlansoprazole

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ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 22 USDMF, 7 EU WC, 9 KDMF, 15 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

24 Drugs in Development

24 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

53 FDF Dossiers, 9 FDA Orange Book, 10 Europe, 4 Canada, 2 South Africa, 28 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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

RELATED EXCIPIENT COMPANIES

6 Evonik, 1 Rochem International Inc, 5 SPI Pharma, 8 DKSH, 1 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 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, 11 Ideal Cures, 2 Ingredion Pharma Solutions, 9 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

59 Coating Systems & Additives, 26 Controlled & Modified Release, 18 Fillers, Diluents & Binders, 17 Solubilizers, 14 Thickeners and Stabilizers, 11 Film Formers & Plasticizers, 9 Taste Masking, 9 Parenteral, 7 Co-Processed Excipients, 7 Direct Compression, 7 Emulsifying Agents, 7 Rheology Modifiers, 5 Empty Capsules, 5 Disintegrants & Superdisintegrants, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 Coloring Agents, 4 Chewable & Orodispersible Aids, 4 Lubricants & Glidants, 3 Granulation, 3 Topical, 1 Soft Gelatin

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GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 9 Annual Reports

MARKET PLACE

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PATENTS & EXCLUSIVITIES

35 US Patents, 52 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 Others

1 Others

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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)

Setid Cad21e6f 7ae1 4fd2 Ae36 Ea256c3e6eaf Applno 22287 Form Capsule Delayed Release Oral Dosage 30mg - Drug Product Composition: Dexlansoprazole