Prestwick3_000161

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 7 USDMF, 5 CEP/COS, 1 JDMF, 2 EU WC, 7 NDC API, 5 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

22 Drugs in Development

22 Drugs in Development

FINISHED DOSAGE FORMULATIONS

176 FDF Dossiers, 61 FDA Orange Book, 35 Europe, 3 Canada, 1 Australia, 59 South Africa, 17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 50MG;300MG;120MG, TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 50MG/5ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 3 Rochem International Inc, 12 SPI Pharma, 12 DKSH, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 3 Kirsch Pharma, 4 ACG Worldwide, 4 Actylis, 2 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 17 BASF, 1 CD Formulation, 7 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 1 Ideal Cures, 4 Ingredion Pharma Solutions, 14 Kerry, 4 Keval Exports, 1 Kima Chemical, 3 Lonza Capsugel, 18 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 27 Roquette, 2 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 5 Silverline Chemicals, 1 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 6 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

63 Fillers, Diluents & Binders, 34 Thickeners and Stabilizers, 30 Direct Compression, 28 Granulation, 27 Disintegrants & Superdisintegrants, 23 Lubricants & Glidants, 17 Coating Systems & Additives, 16 Film Formers & Plasticizers, 15 Co-Processed Excipients, 14 Parenteral, 14 Taste Masking, 13 Solubilizers, 9 Chewable & Orodispersible Aids, 9 Controlled & Modified Release, 8 Empty Capsules, 8 Topical, 7 Rheology Modifiers, 7 Emulsifying Agents, 3 API Stability Enhancers, 3 Coloring Agents, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

9 News #PharmaBuzz

9 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 15 Regulatory FDF Prices

MARKET PLACE

12 APIs, 5 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 3 Others

ANALYTICAL

2 Analytical Methods

2 Analytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 50705 / DOSAGE - TABLET;ORAL - 50MG;300MG;120MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
isoniazid(UNII: V83O1VOZ8L) (isoniazid - UNII:V83O1VOZ8L)	isoniazid	50mg
pyrazinamide(UNII: 2KNI5N06TI) (pyrazinamide - UNII:2KNI5N06TI)	pyrazinamide	300mg
rifampin(UNII: VJT6J7R4TR) (rifampin - UNII:VJT6J7R4TR)	rifampin	120mg

Inactive Ingredients

Ingredient Name	sanofi-aventis U.S. LLC
acacia(5C5403N26O)
aluminum hydroxide(5QB0T2IUN0)
calcium stearate(776XM7047L)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM(K679OBS311)
carnauba wax(R12CBM0EIZ)
ferric oxide red(1K09F3G675)
ferrosoferric oxide(XM0M87F357)
kaolin(24H4NWX5CO)
lecithin, soybean(1DI56QDM62)
magnesium carbonate(0E53J927NA)
PARAFFIN(I9O0E3H2ZE)
POVIDONE, UNSPECIFIED(FZ989GH94E)
propylene glycol(6DC9Q167V3)
rosin(88S87KL877)
shellac(46N107B71O)
silicon dioxide(ETJ7Z6XBU4)
sodium lauryl sulfate(368GB5141J)
sucrose(C151H8M554)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)
white wax(7G1J5DA97F)

Drug Product Composition: Prestwick3_000161