Ceftibuten Dihydrate

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ACTIVE PHARMA INGREDIENTS

2 API Suppliers, 1 EU WC, 1 Listed Suppliers, $ API Reference Price

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

7 FDF Dossiers, 3 FDA Orange Book, 2 Europe, 2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SUSPENSION;ORAL - EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FOR SUSPENSION;ORAL - EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 9 DKSH, 1 Jai Radhe Sales, 1 Pharm-RX Chemical, 7 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 4 Actylis, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 6 BASF, 3 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 3 Kerry, 3 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 11 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

24 Fillers, Diluents & Binders, 23 Thickeners and Stabilizers, 16 Direct Compression, 14 Lubricants & Glidants, 14 Disintegrants & Superdisintegrants, 11 Solubilizers, 10 Coating Systems & Additives, 9 Co-Processed Excipients, 9 Granulation, 8 Empty Capsules, 8 Topical, 7 Parenteral, 6 Taste Masking, 6 Emulsifying Agents, 5 Film Formers & Plasticizers, 5 Controlled & Modified Release, 4 Rheology Modifiers, 3 API Stability Enhancers, 3 Surfactant & Foaming Agents, 2 Coloring Agents, 2 Chewable & Orodispersible Aids

GLOBAL SALES INFORMATION

1 Finished Drug Prices

1 Finished Drug Prices

MARKET PLACE

2 APIs

2 APIs

$ Xls

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USFDA APPLICATION NUMBER - 50686 / DOSAGE - FOR SUSPENSION;ORAL - EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ceftibuten dihydrate(UNII: 62F4443RWP) (CEFTIBUTEN - UNII:IW71N46B4Y)	CEFTIBUTEN	400mg \| 180mg in 5

Inactive Ingredients

Ingredient Name	Macoven Pharmaceuticals	Pernix Therapeutics, LLC
BENZYL ALCOHOL(LKG8494WBH)
BUTYLPARABEN(3QPI1U3FV8)
EDETATE CALCIUM DISODIUM(25IH6R4SGF)
GELATIN, UNSPECIFIED(2G86QN327L)
MAGNESIUM STEARATE(70097M6I30)
METHYLPARABEN(A2I8C7HI9T)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYSORBATE 80(6OZP39ZG8H)
PROPYLPARABEN(Z8IX2SC1OH)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM PROPIONATE(DK6Y9P42IN)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
SUCROSE(C151H8M554)
TITANIUM DIOXIDE(15FIX9V2JP)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Ceftibuten Dihydrate