Fexofenadine

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ACTIVE PHARMA INGREDIENTS

85 API Suppliers, 23 USDMF, 11 CEP/COS, 17 JDMF, 13 EU WC, 13 KDMF, 20 NDC API, 46 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

22 Drugs in Development

22 Drugs in Development

INTERMEDIATES

24 Intermediate Suppliers

24 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

332 FDF Dossiers, 99 FDA Orange Book, 102 Europe, 4 Canada, 5 Australia, 34 South Africa, 88 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION;ORAL - 30MG/5ML, TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG, TABLET;ORAL - 180MG, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG, TABLET, ORALLY DISINTEGRATING;ORAL - 30MG, SUSPENSION;ORAL - 30MG/5ML

RELATED EXCIPIENT COMPANIES

1 Minakem, 6 Rochem International Inc, 19 SPI Pharma, 13 DKSH, 2 Pharm-RX Chemical, 10 Boai NKY Pharmaceuticals Ltd, 8 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 9 Kirsch Pharma, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 36 BASF, 1 Bioplus Life Sciences, 2 CD Formulation, 1 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Esteem Industries, 2 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 4 Ideal Cures, 5 Ingredion Pharma Solutions, 24 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 2 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

92 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 49 Direct Compression, 47 Thickeners and Stabilizers, 44 Disintegrants & Superdisintegrants, 41 Granulation, 33 Solubilizers, 32 Taste Masking, 31 Controlled & Modified Release, 28 Lubricants & Glidants, 26 Film Formers & Plasticizers, 25 Chewable & Orodispersible Aids, 25 Parenteral, 23 Topical, 15 Co-Processed Excipients, 10 Emulsifying Agents, 10 Rheology Modifiers, 9 Empty Capsules, 8 API Stability Enhancers, 6 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

29 News #PharmaBuzz

29 News #PharmaBuzz

GLOBAL SALES INFORMATION

49 Regulatory FDF Prices, 9 Annual Reports

MARKET PLACE

36 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 19 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 4 JP, 10 Others

ANALYTICAL

1 BioAnalytical Methods, 5 Analytical Methods

$ Xls

Filters

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USFDA APPLICATION NUMBER - 201373 / DOSAGE - SUSPENSION;ORAL - 30MG/5ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE(UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	30mg in 5 \| 30mg in 5

Inactive Ingredients

Ingredient Name	sanofi-aventis U.S. LLC	Actavis Pharma, Inc.	Cardinal Health, Inc.	Chain Drug Consortium, LLC	CVS Pharmacy	HEB	Kroger Company	Meijer Distribution Inc	Rite Aid	Rugby Laboratories	Supervalu Inc	Topco Associates LLC	Wal-Mart Stores Inc	Walgreen Company	Chattem, Inc.
anhydrous citric acid(XF417D3PSL)
aspartame(Z0H242BBR1)
BUTYLPARABEN(3QPI1U3FV8)
cellulose acetate(3J2P07GVB6)
cellulose, microcrystalline(OP1R32D61U)
croscarmellose sodium(M28OL1HH48)
crospovidone(68401960MK)
EDETATE DISODIUM(7FLD91C86K)
hypromelloses(3NXW29V3WO)
magnesium stearate(70097M6I30)
mannitol(3OWL53L36A)
POLOXAMER 407(TUF2IVW3M2)
polyethylene glycols(3WJQ0SDW1A)
POTASSIUM SORBATE(1VPU26JZZ4)
povidone K30(U725QWY32X)
povidone(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
silicon dioxide(ETJ7Z6XBU4)
sodium bicarbonate(8MDF5V39QO)
sodium chloride(451W47IQ8X)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS(22ADO53M6F)
sodium phosphate, dibasic, heptahydrate(70WT22SF4B)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(KH7I04HPUU)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(593YOG76RN)
SUCROSE(C151H8M554)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)
XANTHAN GUM(TTV12P4NEE)
XYLITOL(VCQ006KQ1E)

Drug Product Composition: Fexofenadine

Fexofenadine

Fexofenadine

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

85 API Suppliers

23 USDMF

11 CEP/COS

17 JDMF

13 EU WC

13 KDMF

20 NDC API

46 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

22 Drugs in Development

INTERMEDIATES

24 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

332 FDF Dossiers

99 FDA Orange Book

102 Europe

4 Canada

5 Australia

34 South Africa

88 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION;ORAL - 30MG/5ML

TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG

TABLET;ORAL - 180MG

TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 60MG

TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG

TABLET, ORALLY DISINTEGRATING;ORAL - 30MG

SUSPENSION;ORAL - 30MG/5ML

RELATED EXCIPIENT COMPANIES

1 Minakem

6 Rochem International Inc

19 SPI Pharma

13 DKSH

2 Pharm-RX Chemical

10 Boai NKY Pharmaceuticals Ltd

8 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 Shanghai Minbiotech

2 Pfanstiehl

9 Kirsch Pharma

4 ACG Worldwide

12 Actylis

1 Aeon Procare

2 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 Ashland

36 BASF

1 Bioplus Life Sciences

2 CD Formulation

1 Clariant

11 Corel Pharma Chem

7 DFE Pharma

2 Esteem Industries

2 Finar

12 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

4 Ideal Cures

5 Ingredion Pharma Solutions

24 Kerry

3 Keval Exports

4 Kima Chemical

6 Lonza Capsugel

18 Microlex e.U

2 Nanjing Bold Chemical

3 Nitika Pharmaceutical Specialities

2 Nomisma Healthcare

4 Novo Excipients

5 Pharmatrans-Sanaq

8 Pluviaendo

4 Prachin Chemical

TABLET;ORAL - 30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons