Fexofenadine Hydrochloride

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ACTIVE PHARMA INGREDIENTS

77 API Suppliers, 23 USDMF, 12 CEP/COS, 15 JDMF, 15 EU WC, 10 KDMF, 25 NDC API, 47 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

26 Intermediates Suppliers

26 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

288 FDF Dossiers, 96 FDA Orange Book, 76 Europe, 4 Canada, 5 Australia, 30 South Africa, 77 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TABLET;ORAL - 180MG, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG, TABLET, ORALLY DISINTEGRATING;ORAL - 30MG,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, 18 SPI Pharma, 2 Seqens, 11 DKSH, 2 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 36 BASF, 1 Bioplus Life Sciences, 1 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 37 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 18 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 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, 12 Sigachi Industries, 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

111 Fillers, Diluents & Binders, 59 Coating Systems & Additives, 54 Direct Compression, 44 Thickeners and Stabilizers, 43 Disintegrants & Superdisintegrants, 36 Controlled & Modified Release, 36 Granulation, 31 Taste Masking, 31 Solubilizers, 29 Lubricants & Glidants, 28 Film Formers & Plasticizers, 23 Chewable & Orodispersible Aids, 22 Topical, 22 Co-Processed Excipients, 20 Parenteral, 9 Empty Capsules, 9 API Stability Enhancers, 8 Emulsifying Agents, 7 Rheology Modifiers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

74 Finished Drug Prices, 9 Annual Reports

MARKET PLACE

33 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 13 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 3 USP, 4 JP, 6 Others

ANALYTICAL

1 BioAnalytical Methods, 5 Analytical Methods

$ Xls

Filters

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USFDA APPLICATION NUMBER - 21704 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
fexofenadine hydrochloride(UNII: 2S068B75ZU) (Fexofenadine - UNII:E6582LOH6V)	fexofenadine hydrochloride	180mg
pseudoephedrine hydrochloride(UNII: 6V9V2RYJ8N) (pseudoephedrine - UNII:7CUC9DDI9F)	pseudoephedrine hydrochloride	240mg

Inactive Ingredients

Ingredient Name	sanofi-aventis U.S. LLC	STAT RX USA LLC	Dr.Reddy's Laboratories Limited
ACETONE(1364PS73AF)
acetyltributyl citrate(0ZBX0N59RZ)
aluminum oxide(LMI26O6933)
cellulose acetate(3J2P07GVB6)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
colloidal silicon dioxide(ETJ7Z6XBU4)
copovidone(D9C330MD8B)
CROSCARMELLOSE SODIUM(M28OL1HH48)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FD&C Blue No. 1(H3R47K3TBD)
HYDROGENATED COTTONSEED OIL(Z82Y2C65EA)
HYPROMELLOSE(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
isopropyl alcohol(ND2M416302)
magnesium stearate(70097M6I30)
METHYL ALCOHOL(Y4S76JWI15)
methylene chloride(588X2YUY0A)
polyethylene glycol(3WJQ0SDW1A)
povidone(FZ989GH94E)
silicon dioxide(ETJ7Z6XBU4)
SODIUM CHLORIDE(451W47IQ8X)
sodium stearyl fumarate(7CV7WJK4UI)
talc(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
water(059QF0KO0R)

Drug Product Composition: Fexofenadine Hydrochloride