Zolpidem Hemitartrate

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ACTIVE PHARMA INGREDIENTS

63 API Suppliers, 34 USDMF, 22 CEP/COS, 12 JDMF, 11 EU WC, 9 KDMF, 11 NDC API, 27 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

5 API Suppliers

5 API Suppliers

FINISHED DOSAGE FORMULATIONS

263 FDF Dossiers, 82 FDA Orange Book, 121 Europe, 12 Canada, 22 South Africa, 26 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 5MG, TABLET, EXTENDED RELEASE;ORAL - 12.5MG, TABLET, EXTENDED RELEASE;ORAL - 6.25MG, SPRAY, METERED;ORAL - 5MG/SPRAY, TABLET;SUBLINGUAL - 1.75MG, TABLET;SUBLINGUAL - 3.5MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Evonik, 5 Rochem International Inc, 20 SPI Pharma, 2 Seqens, 5 DKSH, 3 Jai Radhe Sales, 1 Pharm-RX Chemical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 17 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 3 Alcedo Pharmachem, 12 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 36 BASF, 1 Bioplus Life Sciences, 2 Clariant, 16 Corel Pharma Chem, 7 DFE Pharma, 2 Finar, 14 Gangwal Chemicals, 15 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 39 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 5 Pharmatrans-Sanaq, 8 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 29 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Valens Pharmachem, 4 Vasa Pharmachem, 1 Vertellus, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

96 Fillers, Diluents & Binders, 77 Coating Systems & Additives, 51 Direct Compression, 47 Disintegrants & Superdisintegrants, 45 Controlled & Modified Release, 33 Taste Masking, 31 Granulation, 31 Solubilizers, 30 Thickeners and Stabilizers, 26 Lubricants & Glidants, 26 Film Formers & Plasticizers, 21 Chewable & Orodispersible Aids, 21 Parenteral, 19 Topical, 19 Co-Processed Excipients, 8 API Stability Enhancers, 8 Emulsifying Agents, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 1 Soft Gelatin

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 38 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 113 Finished Drug Prices, 13 Annual Reports

MARKET PLACE

10 APIs, 3 FDF Dossiers

PATENTS & EXCLUSIVITIES

13 US Patents, 4 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 10 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21774 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12.5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
zolpidem tartrate(UNII: WY6W63843K) (zolpidem - UNII:7K383OQI23)	zolpidem	12.5mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	A-S Medication Solutions LLC	Actavis Pharma, Inc.	American Health Packaging	Bryant Ranch Prepack	Lake Erie Medical DBA Quality Care Products LLC	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Physicians Total Care, Inc.	St Marys Medical Park Pharmacy	STAT Rx USA LLC	Avera McKennan Hospital	Golden State Medical Supply	Golden State Medical Supply, Inc.	Par Pharmaceutical, Inc.	NuCare Pharmaceuticals,Inc.	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	sanofi-aventis U.S. LLC	St. Mary's Medical Park Pharmacy	Unit Dose Services
ANHYDROUS LACTOSE(3SY5LH9PMK)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
D&C YELLOW NO. 10(35SW5USQ3G)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C Blue No. 2(L06K8R7DQK)
FD&C YELLOW NO. 6(H77VEI93A8)
ferric oxide red(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)
HYPROMELLOSE 2208 (4000 MPA.S)(39J80LT57T)
HYPROMELLOSE 2910 (5 MPA.S)(R75537T0T4)
hypromellose, unspecified(3NXW29V3WO)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
magnesium stearate(70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(NX76LV5T8J)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(74G4R6TH13)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYDEXTROSE(VH2XOU12IE)
POLYETHYLENE GLYCOL 1000(U076Q6Q621)
polyethylene glycol(3WJQ0SDW1A)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)
POLYSORBATE 80(6OZP39ZG8H)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
potassium bitartrate(NPT6P8P3UU)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
PROPYLENE GLYCOL(6DC9Q167V3)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM BICARBONATE(8MDF5V39QO)
SODIUM LAURYL SULFATE(368GB5141J)
sodium starch glycolate type a corn(AG9B65PV6B)
SUCROSE(C151H8M554)
TALC(7SEV7J4R1U)
TARTARIC ACID(W4888I119H)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)
TRIETHYL CITRATE(8Z96QXD6UM)

Drug Product Composition: Zolpidem Hemitartrate