Pseudoephedrine Sulfate

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ACTIVE PHARMA INGREDIENTS

9 API Suppliers, 3 USDMF, 2 EU WC, 2 KDMF, 5 NDC API, 8 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

29 FDF Dossiers, 22 FDA Orange Book, 3 Canada, 3 South Africa, 1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 5MG;120MG, TABLET, EXTENDED RELEASE;ORAL - 10MG;240MG, TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

RELATED EXCIPIENT COMPANIES

1 Evonik, 7 SPI Pharma, 2 Seqens, 16 DKSH, 2 Jai Radhe Sales, 6 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 2 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 27 BASF, 1 Clariant, 12 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 10 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 31 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

83 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 37 Direct Compression, 36 Controlled & Modified Release, 29 Thickeners and Stabilizers, 27 Solubilizers, 25 Granulation, 21 Disintegrants & Superdisintegrants, 19 Film Formers & Plasticizers, 18 Lubricants & Glidants, 17 Topical, 17 Co-Processed Excipients, 14 Taste Masking, 13 Parenteral, 9 Empty Capsules, 8 Emulsifying Agents, 8 Chewable & Orodispersible Aids, 5 Surfactant & Foaming Agents, 5 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules

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REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 20470 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG;240MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE(UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10mg
PSEUDOEPHEDRINE SULFATE(UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	240mg

Inactive Ingredients

Ingredient Name	Bryant Ranch Prepack	REMEDYREPACK INC.	Actavis Pharma, Inc.	Bayer HealthCare LLC.	Costco Wholesale Corporation	L Perrigo Company	TOP CARE (Topco Associates LLC)	HyVee Inc	Meijer Distribution Inc	Perrigo New York Inc	Walgreen Company
CALCIUM CARBONATE(H0G9379FGK)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(O7TSZ97GEP)
CANDELILLA WAX(WL0328HX19)
CARNAUBA WAX(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
ETHYLCELLULOSES(7Z8S9VYZ4B)
FERROSOFERRIC OXIDE(XM0M87F357)
GLYCERYL MONOSTEARATE(230OU9XXE4)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(0WZ8WG20P6)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM ALGINATE(C269C4G2ZQ)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SODIUM LAURYL SULFATE(368GB5141J)
STARCH, CORN(O8232NY3SJ)
STARCH, PREGELATINIZED CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Pseudoephedrine Sulfate