Diazepam

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers, 7 USDMF, 4 CEP/COS, 2 JDMF, 3 EU WC, 9 NDC API, 13 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

33 Drugs in Development

33 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

357 FDF Dossiers, 127 FDA Orange Book, 129 Europe, 15 Canada, 31 Australia, 18 South Africa, 37 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 2MG, TABLET;ORAL - 5MG, GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 2.5MG/0.5ML (5MG/ML), GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 1 DKSH, 5 Faran Shimi Pharmaceutical, 13 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 4 Actylis, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 2 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 3 Finar, 6 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 30 Direct Compression, 28 Disintegrants & Superdisintegrants, 26 Controlled & Modified Release, 20 Thickeners and Stabilizers, 19 Lubricants & Glidants, 19 Granulation, 18 Film Formers & Plasticizers, 16 Topical, 15 Co-Processed Excipients, 13 Taste Masking, 9 Parenteral, 9 Solubilizers, 8 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Rheology Modifiers, 2 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 69 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 136 Finished Drug Prices, 3 Annual Reports

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30 APIs, 24 FDF Dossiers

PATENTS & EXCLUSIVITIES

23 US Patents, 8 US Exclusivities, 1 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 10 Others

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USFDA APPLICATION NUMBER - 13263 / DOSAGE - TABLET;ORAL - 5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIAZEPAM(UNII: Q3JTX2Q7TU) (DIAZEPAM - UNII:Q3JTX2Q7TU)	DIAZEPAM	5mg

Inactive Ingredients

Ingredient Name	KAISER FOUNDATION HOSPITALS	A-S Medication Solutions	Actavis Pharma, Inc.	Bryant Ranch Prepack	Cardinal Health	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	Lake Erie Medical DBA Quality Care Products LLC	Major Pharmaceuticals	Mayne Pharma	McKesson Contract Packaging	Mckesson Rxpak Inc	NCS HealthCare of KY, LLC dba Vangard Labs	NuCare Pharmaceuticals, Inc.	PD-Rx Pharmaceuticals, Inc.	Preferred Pharmaceuticals Inc.	Quality Care Products LLC	REMEDYREPACK INC.	St. Mary's Medical Park Pharmacy	Teva Pharmaceuticals USA, Inc.	A-S Medication Solutions LLC	Preferred Pharmaceuticals, Inc.	Proficient Rx LP	Qualitest Pharmaceuticals	Unit Dose Services	NCS HealthCare of KY, Inc dba Vangard Labs
ALUMINUM OXIDE(LMI26O6933)
ANHYDROUS LACTOSE(3SY5LH9PMK)
calcium stearate(776XM7047L)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10 ALUMINUM LAKE(CQ3XH3DET6)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1 ALUMINUM LAKE(J9EQA3S2JM)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C YELLOW NO. 6(H77VEI93A8)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)

Drug Product Composition: Diazepam

Diazepam

Diazepam

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

17 API Suppliers

7 USDMF

4 CEP/COS

2 JDMF

3 EU WC

9 NDC API

13 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

33 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

357 FDF Dossiers

127 FDA Orange Book

129 Europe

15 Canada

31 Australia

18 South Africa

37 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG

TABLET;ORAL - 2MG

TABLET;ORAL - 5MG

GEL;RECTAL - 10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;RECTAL - 15MG/3ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;RECTAL - 2.5MG/0.5ML (5MG/ML)

GEL;RECTAL - 20MG/4ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;RECTAL - 5MG/ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

6 SPI Pharma

2 Seqens

1 DKSH

5 Faran Shimi Pharmaceutical

13 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 ACG Worldwide

4 Actylis

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

14 BASF

2 Clariant

10 Corel Pharma Chem

7 DFE Pharma

3 Finar

6 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

36 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

27 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

1 Valens Pharmachem

5 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

65 Fillers, Diluents & Binders

47 Coating Systems & Additives

30 Direct Compression

GEL;RECTAL - 10MG/2ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;RECTAL - 15MG/3ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;RECTAL - 20MG/4ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;RECTAL - 5MG/ML (5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons