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 - 21313 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 2.5MG;120MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
desloratadine(UNII: FVF865388R) (desloratadine - UNII:FVF865388R)	desloratadine	2.5mg
pseudoephedrine sulfate(UNII: Y9DL7QPE6B) (pseudoephedrine - UNII:7CUC9DDI9F)	pseudoephedrine sulfate	120mg

Inactive Ingredients

Ingredient Name	Merck Sharp & Dohme Corp.
aluminum oxide(LMI26O6933)
anhydrous citric acid(XF417D3PSL)
edetate disodium(7FLD91C86K)
FD&C Blue No. 2(L06K8R7DQK)
hypromellose, unspecified(3NXW29V3WO)
magnesium stearate(70097M6I30)
microcrystalline cellulose(OP1R32D61U)
povidone, unspecified(FZ989GH94E)
silicon dioxide(ETJ7Z6XBU4)
starch, corn(O8232NY3SJ)
stearic acid(4ELV7Z65AP)

Drug Product Composition: Pseudoephedrine Sulfate