Ibandronate Sodium

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ACTIVE PHARMA INGREDIENTS

54 API Suppliers, 14 USDMF, 3 CEP/COS, 1 JDMF, 6 EU WC, 25 KDMF, 6 NDC API, 20 Listed Suppliers, $ API Reference Price

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2 Drugs in Development

2 Drugs in Development

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5 Intermediate Suppliers

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DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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1 Minakem, 1 Rochem International Inc, 4 SPI Pharma, 6 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 3 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 22 BASF, 1 Clariant, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 2 Finar, 8 Gangwal Chemicals, 5 Ideal Cures, 1 Ingredion Pharma Solutions, 21 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 19 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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PATENTS & EXCLUSIVITIES

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REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 21858 / DOSAGE - INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IBANDRONATE SODIUM(UNII: J12U072QL0) (IBANDRONIC ACID - UNII:UMD7G2653W)	IBANDRONIC ACID	3mg in 3

Inactive Ingredients

Ingredient Name	Genentech, Inc.
ACETIC ACID(Q40Q9N063P)
SODIUM ACETATE(4550K0SC9B)
SODIUM CHLORIDE(451W47IQ8X)
WATER(059QF0KO0R)

Setid 5500be0f 8b29 450c 9857 755029965157 Applno 21858 Form Injectable Intravenous Dosage Eq 3mg Base 3ml - Drug Product Composition: Ibandronate Sodium