Sildenafil Citrate

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ACTIVE PHARMA INGREDIENTS

70 API Suppliers, 20 USDMF, 20 CEP/COS, 5 JDMF, 18 EU WC, 14 KDMF, 28 NDC API, 46 Listed Suppliers, $ API Reference Price

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36 Drugs in Development

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14 Intermediates Suppliers

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553 FDF Dossiers, 98 FDA Orange Book, 181 Europe, 51 Canada, 36 Australia, 53 South Africa, 134 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SUSPENSION;ORAL - EQ 10MG BASE/ML, TABLET;ORAL - EQ 100MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 20MG BASE

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PATENTS & EXCLUSIVITIES

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REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 11 Others

ANALYTICAL

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2 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 203109 / DOSAGE - FOR SUSPENSION;ORAL - EQ 10MG BASE/ML

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SILDENAFIL CITRATE(UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H)	SILDENAFIL	10mg in 1

Inactive Ingredients

Ingredient Name	Ascend Laboratories, LLC	Greenstone LLC	Lupin Pharmaceuticals, Inc.	Zydus Lifesciences Limited	Zydus Pharmaceuticals (USA) Inc.
ANHYDROUS CITRIC ACID(XF417D3PSL)
CARBOMER HOMOPOLYMER TYPE A(F68VH75CJC)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BENZOATE(OJ245FE5EU)
SODIUM CITRATE(1Q73Q2JULR)
SORBITOL(506T60A25R)
SUCRALOSE(96K6UQ3ZD4)
TITANIUM DIOXIDE(15FIX9V2JP)
TRISODIUM CITRATE DIHYDRATE(B22547B95K)
XANTHAN GUM(TTV12P4NEE)

Drug Product Composition: Sildenafil Citrate