Dexlansoprazole Sesquihydrate

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FINISHED DOSAGE FORMULATIONS

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DRUG PRODUCT COMPOSITIONS

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

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3 Evonik, 1 Rochem International Inc, 5 SPI Pharma, 6 DKSH, 2 Faran Shimi Pharmaceutical, 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

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REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 22287 / DOSAGE - CAPSULE, DELAYED RELEASE;ORAL - 60MG

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