EFAVIRENZ [USP MONOGRAPH]

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

50 API Suppliers, 28 USDMF, 8 EU WC, 2 KDMF, 16 NDC API, 19 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

251 FDF Dossiers, 59 FDA Orange Book, 94 Europe, 8 Canada, 1 Australia, 68 South Africa, 21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 400MG;300MG;300MG, CAPSULE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures, 2 Ingredion Pharma Solutions, 21 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 12 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 32 Fillers, Diluents & Binders, 24 Disintegrants & Superdisintegrants, 23 Controlled & Modified Release, 20 Granulation, 16 Thickeners and Stabilizers, 16 Lubricants & Glidants, 15 Direct Compression, 11 Topical, 9 Empty Capsules, 8 Co-Processed Excipients, 7 Film Formers & Plasticizers, 6 Taste Masking, 5 API Stability Enhancers, 5 Solubilizers, 4 Emulsifying Agents, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 3 Rheology Modifiers, 3 Parenteral, 2 Coloring Agents, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

55 News #PharmaBuzz

55 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 12 Regulatory FDF Prices, 15 Annual Reports

MARKET PLACE

9 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

5 US Patents, 18 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 USP, 9 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21937 / DOSAGE - TABLET;ORAL - 600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
efavirenz(UNII: JE6H2O27P8) (efavirenz - UNII:JE6H2O27P8)	efavirenz	600mg
emtricitabine(UNII: G70B4ETF4S) (emtricitabine - UNII:G70B4ETF4S)	emtricitabine	200mg
tenofovir disoproxil fumarate(UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)	tenofovir disoproxil fumarate	300mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Avera McKennan Hospital	Lake Erie Medical DBA Quality Care Products LLC	REMEDYREPACK INC.
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FERRIC OXIDE RED(1K09F3G675)
FERROSOFERRIC OXIDE(XM0M87F357)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE(RFW2ET671P)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SODIUM LAURYL SULFATE(368GB5141J)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.

Setid 5c6c7ba4 6d42 4e07 A127 B3cf72c866ad Applno 21937 Form Tablet Oral Dosage 600mg 200mg 300mg - Drug Product Composition: EFAVIRENZ [USP MONOGRAPH]