Tenofovir Alafenamide Fumarate

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ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 25 USDMF, 7 EU WC, 4 KDMF, 13 NDC API, 22 Listed Suppliers, $ API Reference Price

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

13 FDF Dossiers, 13 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE, TABLET;ORAL - 120MG;EQ 15MG BASE, TABLET;ORAL - 200MG;EQ 25MG BASE, TABLET;ORAL - 200MG;EQ 25MG BASE;EQ 25MG BASE, TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE, TABLET;ORAL - EQ 50MG BASE;200MG;EQ 25MG BASE

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Seqens, 3 DKSH, 5 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 24 BASF, 5 Corel Pharma Chem, 5 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 3 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 20 Kerry, 10 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 10 Roquette, 2 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders, 24 Direct Compression, 23 Coating Systems & Additives, 19 Granulation, 17 Controlled & Modified Release, 16 Thickeners and Stabilizers, 16 Disintegrants & Superdisintegrants, 15 Lubricants & Glidants, 14 Solubilizers, 12 Co-Processed Excipients, 12 Topical, 9 Parenteral, 6 Film Formers & Plasticizers, 5 Taste Masking, 3 Surfactant & Foaming Agents, 3 Coloring Agents, 2 Rheology Modifiers, 2 Emulsifying Agents, 2 Chewable & Orodispersible Aids, 1 API Stability Enhancers

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MARKET PLACE

8 APIs

8 APIs

PATENTS & EXCLUSIVITIES

90 US Patents, 12 US Exclusivities

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 207561 / DOSAGE - TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COBICISTAT(UNII: LW2E03M5PG) (COBICISTAT - UNII:LW2E03M5PG)	COBICISTAT	150mg
ELVITEGRAVIR(UNII: 4GDQ854U53) (ELVITEGRAVIR - UNII:4GDQ854U53)	ELVITEGRAVIR	150mg
EMTRICITABINE(UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S)	EMTRICITABINE	200mg
TENOFOVIR ALAFENAMIDE FUMARATE(UNII: FWF6Q91TZO) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)	TENOFOVIR ANHYDROUS	10mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	REMEDYREPACK INC.
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 2(L06K8R7DQK)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SODIUM LAURYL SULFATE(368GB5141J)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)

Drug Product Composition: Tenofovir Alafenamide Fumarate