Pseudoephedrine Hydrochloride

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ACTIVE PHARMA INGREDIENTS

37 API Suppliers, 24 USDMF, 10 CEP/COS, 1 JDMF, 3 EU WC, 6 KDMF, 12 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

FINISHED DOSAGE FORMULATIONS

312 FDF Dossiers, 112 FDA Orange Book, 3 Europe, 114 Canada, 50 South Africa, 33 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 200MG;30MG, CAPSULE;ORAL - 8MG;60MG, TABLET, EXTENDED RELEASE;ORAL - 240MG, TABLET, EXTENDED RELEASE;ORAL - 60MG;120MG, CAPSULE;ORAL - EQ 200MG FREE ACID AND POTASSIUM SALT;30MG, TABLET;ORAL - 2MG;200MG;30MG, TABLET, EXTENDED RELEASE;ORAL - 1.2GM;120MG, TABLET, EXTENDED RELEASE;ORAL - 600MG;60MG, TABLET, EXTENDED RELEASE;ORAL - 180MG;240MG, SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML, SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 2MG/5ML;10MG/5ML;30MG/5ML

RELATED EXCIPIENT COMPANIES

1 Minakem, 9 Rochem International Inc, 21 SPI Pharma, 2 Seqens, 13 DKSH, 2 Pharm-RX Chemical, 9 Faran Shimi Pharmaceutical, 12 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 16 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 15 Actylis, 4 Aeon Procare, 3 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 38 BASF, 1 Bioplus Life Sciences, 2 Clariant, 12 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 14 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 18 Microlex e.U, 2 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 10 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 37 Roquette, 14 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 3 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem, 2 Vertellus, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

124 Fillers, Diluents & Binders, 63 Coating Systems & Additives, 58 Direct Compression, 46 Disintegrants & Superdisintegrants, 45 Thickeners and Stabilizers, 42 Controlled & Modified Release, 37 Granulation, 36 Taste Masking, 35 Film Formers & Plasticizers, 35 Solubilizers, 31 Topical, 31 Lubricants & Glidants, 29 Parenteral, 25 Chewable & Orodispersible Aids, 23 Co-Processed Excipients, 11 API Stability Enhancers, 10 Emulsifying Agents, 9 Empty Capsules, 9 Rheology Modifiers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 31 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 Finished Drug Prices

1 Finished Drug Prices

MARKET PLACE

24 APIs

24 APIs

PATENTS & EXCLUSIVITIES

2 US Patents

2 US Patents

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 Others

$ Xls

Filters

Xls

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: Pseudoephedrine Hydrochloride