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 - 22328 / DOSAGE - TABLET;SUBLINGUAL - 1.75MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
zolpidem tartrate(UNII: WY6W63843K) (zolpidem - UNII:7K383OQI23)	zolpidem tartrate	3.5mg \| 1.75mg

Inactive Ingredients

Ingredient Name	Lupin Pharmaceuticals,Inc.	Novel Laboratories, Inc.	Purdue Pharma LP
ASPARTAME(Z0H242BBR1)
croscarmellose sodium(M28OL1HH48)
CROSPOVIDONE(2S7830E561)
crospovidone(68401960MK)
CROSPOVIDONE, UNSPECIFIED(2S7830E561)
ferric oxide yellow(EX438O2MRT)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
POLYVINYL ACETATE PHTHALATE(58QVG85GW3)
POVIDONE(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
sodium bicarbonate (8MDF5V39QO)
SODIUM BICARBONATE(8MDF5V39QO)
SODIUM CARBONATE(45P3261C7T)
sodium stearyl fumarate(7CV7WJK4UI)
sorbitol(506T60A25R)
sucralose(96K6UQ3ZD4)

Drug Product Composition: Zolpidem Hemitartrate