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TABLET;ORAL - 180MG, TABLET;ORAL - 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 60MG, TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG, TABLET, ORALLY DISINTEGRATING;ORAL - 30MG,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

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USFDA APPLICATION NUMBER - 20872 / DOSAGE - TABLET;ORAL - 180MG

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	AAA Pharmaceutical, Inc.	AvKARE, Inc.	AvPAK	CHAIN DRUG MARKETING ASSOCIATION INC.	DISCOUNT DRUG MART	Golden State Medical Supply, Inc.	Harris Teeter	Healthmart	Lidl US, LLC	Little Pharma, Inc.	Magno-Humphries, Inc.	Marc Glassman, Inc.	Preferred Pharmaceuticals Inc.	REMEDYREPACK INC.	RPK Pharmaceuticals, Inc.	Sunmark	TARGET Corporation	TopCo Associates LLC	Chattem, Inc.	Mylan Institutional Inc.	Mylan Pharmaceuticals Inc.	PD-Rx Pharmaceuticals, Inc.	Sanofi-Synthelabo Limited	7-Eleven	American Sales Company	Amerisource Bergen	Aphena Pharma Solutions - Tennessee, Inc.	Avera McKennan Hospital	Big Lots Stores, Inc.	Cardinal Health	DirectRx	DZA Brands LLC	Harris Teeter, LLC	HyVee Inc	Kinray	Kmart Corporation	Kroger Company	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Lake Erie Medical DBA Quality Care Products LLC	Major Pharmaceuticals	McKesson	Meijer Distribution Inc	NCS HealthCare of KY, Inc dba Vangard Labs	NuCare Pharmaceuticals, Inc.	Perrigo New York Inc	Preferred Plus (Kinray)	Rugby Laboratories	Safeway	Sam's West Inc	Target Corporation	Topco Associates LLC	Wakefern Food Corporation	Walgreen Company	A-S Medication Solutions	Bryant Ranch Prepack	Costco Wholesale Company	DirectRX	Kaiser Permanente	L. Perrigo Company	Navajo Manufacturing Company Inc.	Preferred Pharmac	Proficient Rx LP	Reckitt Benckiser LLC	Preferred Pharmaceuticals, Inc.	Rugby Laborat	REMEDYREPA	Shopko Stores Operating Co., LLC	Supervalu Inc	Wal-Mart Stores Inc	Spirit Pharmaceuticals LLC	\|Bryant Ranch Prepack	sanofi-aventis U.	Pr	Perrigo New York
anhydrous citric acid(XF417D3PSL)
ANHYDROUS LACTOSE(3SY5LH9PMK)
aspartame(Z0H242BBR1)
BROWN IRON OXIDE(1N032N7MFO)
BUTYLATED HYDROXYANISOLE(REK4960K2U)
butylparaben(3QPI1U3FV8)
cellulose acetate(3J2P07GVB6)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
COLLOIDAL SILICON DIOXIDE(ETJ7Z6XBU4)
CORN(0N8672707O)
CROSCARMELLOSE SODIUM(M28OL1HH48)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
crospovidone(68401960MK)
CROSPOVIDONE, UNSPECIFIED(2S7830E561)
D&C RED NO. 28(767IP0Y5NH)
D&C RED NO. 33(9DBA0SBB0L)
edetate disodium(7FLD91C86K)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 40(WZB9127XOA)
FERRIC OXIDE BLACK(XM0M87F357)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
FERROUS OXIDE(G7036X8B5H)
GELATIN(2G86QN327L)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYPROMELLOSE 2208 (3 MPA.S)(9H4L916OBU)
HYPROMELLOSE 2910 (15 MPA.S)(36SFW2JZ0W)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE 2910 (6 CPS)(0WZ8WG20P6)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
hypromellose(3NXW29V3WO)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LIGHT MINERAL OIL(N6K5787QVP)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
poloxamer 407(TUF2IVW3M2)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
povidone K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
POWDERED CELLULOSE(SMD1X3XO9M)
propylene glycol(6DC9Q167V3)
propylparaben(Z8IX2SC1OH)
silicon dioxide(ETJ7Z6XBU4)
sodium bicarbonate(8MDF5V39QO)
sodium chloride(451W47IQ8X)
SODIUM LAURYL SULFATE(368GB5141J)
sodium phosphate, dibasic, heptahydrate(70WT22SF4B)
sodium phosphate, monobasic, monohydrate(593YOG76RN)
SODIUM STARCH GLYCOLATE TYPE A CORN(AG9B65PV6B)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
STARCH, PREGELATINIZED CORN(O8232NY3SJ)
STEARIC ACID(4ELV7Z65AP)
sucrose(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
water(059QF0KO0R)
xanthan gum(TTV12P4NEE)
xylitol(VCQ006KQ1E)

Drug Product Composition: Fexofenadine Hydrochloride