Raltegravir Potassium

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 9 USDMF, 5 CEP/COS, 7 EU WC, 4 KDMF, 8 NDC API, 21 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

18 Intermediate Suppliers

18 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

37 FDF Dossiers, 8 FDA Orange Book, 20 Europe, 3 Canada, 2 Australia, 3 South Africa, 1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 400MG BASE, TABLET;ORAL - EQ 600MG BASE

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1 Minakem, 6 Rochem International Inc, 18 SPI Pharma, 8 DKSH, 1 Pharm-RX Chemical, 8 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 2 Kirsch Pharma, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 6 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 5 DFE Pharma, 1 Esteem Industries, 8 Gangwal Chemicals, 5 Ideal Cures, 2 Ingredion Pharma Solutions, 22 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 6 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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59 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 28 Thickeners and Stabilizers, 27 Direct Compression, 25 Taste Masking, 21 Disintegrants & Superdisintegrants, 20 Granulation, 20 Controlled & Modified Release, 20 Chewable & Orodispersible Aids, 19 Lubricants & Glidants, 17 Film Formers & Plasticizers, 14 Parenteral, 13 Solubilizers, 11 Co-Processed Excipients, 10 Rheology Modifiers, 8 Topical, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Emulsifying Agents, 1 Surfactant & Foaming Agents, 1 Soft Gelatin

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12 News #PharmaBuzz

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2 US Medicaid Prescriptions, 7 Regulatory FDF Prices, 11 Annual Reports

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PATENTS & EXCLUSIVITIES

19 US Patents, 12 Health Canada Patents

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 22145 / DOSAGE - TABLET;ORAL - EQ 600MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
RALTEGRAVIR POTASSIUM(UNII: 43Y000U234) (RALTEGRAVIR - UNII:22VKV8053U)	RALTEGRAVIR	400mg

Inactive Ingredients

Ingredient Name	REMEDYREPACK INC.	A-S Medication Solutions	Avera McKennan Hospital
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLOXAMER 407(TUF2IVW3M2)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SODIUM STEARYL FUMARATE(7CV7WJK4UI)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid 90defbe0 19df 43ed B8e7 D75c473f53ec Applno 22145 Form Tablet Oral Dosage Eq 600mg Base - Drug Product Composition: Raltegravir Potassium