Fexofenadine Hydrochloride

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TABLET;ORAL - 180MG, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG, TABLET, ORALLY DISINTEGRATING;ORAL - 30MG,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

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USFDA APPLICATION NUMBER - 20872 / DOSAGE - TABLET;ORAL - 30MG **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
fexofenadine hydrochloride(UNII: 2S068B75ZU) (Fexofenadine - UNII:E6582LOH6V)	fexofenadine hydrochloride	180mg

Inactive Ingredients

Ingredient Name	sanofi-aventis U.S. LLC	Chattem, Inc.	Sanofi-Synthelabo Limited	NCS HealthCare of KY, Inc dba Vangard Labs	Navajo Manufacturing Company Inc.
anhydrous citric acid(XF417D3PSL)
aspartame(Z0H242BBR1)
BROWN IRON OXIDE(1N032N7MFO)
butylparaben(3QPI1U3FV8)
cellulose acetate(3J2P07GVB6)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
crospovidone(68401960MK)
D&C RED NO. 28(767IP0Y5NH)
D&C RED NO. 33(9DBA0SBB0L)
edetate disodium(7FLD91C86K)
FD&C BLUE NO. 1(H3R47K3TBD)
FERROUS OXIDE(G7036X8B5H)
GELATIN(2G86QN327L)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
hypromellose(3NXW29V3WO)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
magnesium stearate(70097M6I30)
mannitol(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
poloxamer 407(TUF2IVW3M2)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
polyethylene glycol(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
polyethylene glycols(3WJQ0SDW1A)
povidone K30(U725QWY32X)
POVIDONE(FZ989GH94E)
propylene glycol(6DC9Q167V3)
propylparaben(Z8IX2SC1OH)
silicon dioxide(ETJ7Z6XBU4)
sodium bicarbonate(8MDF5V39QO)
sodium chloride(451W47IQ8X)
sodium phosphate, dibasic, heptahydrate(70WT22SF4B)
sodium phosphate, monobasic, monohydrate(593YOG76RN)
STARCH, CORN(O8232NY3SJ)
sucrose(C151H8M554)
TITANIUM DIOXIDE(15FIX9V2JP)
water(059QF0KO0R)
xanthan gum(TTV12P4NEE)
xylitol(VCQ006KQ1E)

Setid Ac0c0247 3b20 445a 84c0 Cb7f3939c823 Applno 20872 Form Tablet Oral Dosage 30mg - Drug Product Composition: Fexofenadine Hydrochloride