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, 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, 7 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 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

81 Fillers, Diluents & Binders, 60 Coating Systems & Additives, 36 Controlled & Modified Release, 36 Direct Compression, 29 Thickeners and Stabilizers, 26 Solubilizers, 25 Granulation, 20 Disintegrants & Superdisintegrants, 19 Film Formers & Plasticizers, 18 Lubricants & Glidants, 17 Co-Processed Excipients, 17 Topical, 14 Taste Masking, 13 Parenteral, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 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 - 19670 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 5MG;120MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE(UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	5mg
PSEUDOEPHEDRINE SULFATE(UNII: Y9DL7QPE6B) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE SULFATE	120mg

Inactive Ingredients

Ingredient Name	American Sales Company	Costco Wholesale Company	CVS Pharmacy	Haleon US Holdings LLC	Harris Teeter, LLC	L. Perrigo Company	McKesson	Perrigo New York Inc	Rite Aid Corporation	Safeway	Supervalu Inc	Walgreen Company	Amerisource Bergen	Bayer HealthCare LLC.	Bryant Ranch Prepack	Kmart Corporation	Kroger Company	Meijer Distribution Inc	Publix Super Markets Inc	Shopko Stores Operating Co., LLC
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CROSCARMELLOSE SODIUM(M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
TITANIUM DIOXIDE(15FIX9V2JP)

Drug Product Composition: Pseudoephedrine Sulfate