Metronidazole

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 16 USDMF, 12 CEP/COS, 1 JDMF, 1 EU WC, 14 KDMF, 11 NDC API, 17 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

16 Drugs in Development

16 Drugs in Development

FINISHED DOSAGE FORMULATIONS

389 FDF Dossiers, 116 FDA Orange Book, 87 Europe, 19 Canada, 10 Australia, 48 South Africa, 109 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 500MG/100ML, INJECTABLE;INJECTION - 500MG/100ML, GEL;TOPICAL - 0.75%, GEL;VAGINAL - 0.75%, GEL;VAGINAL - 1.3%, CREAM;TOPICAL - 0.75%, SUSPENSION;ORAL - 500MG/5ML, GEL;TOPICAL - 1%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 11 DKSH, 1 Jai Radhe Sales, 4 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 12 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 29 BASF, 1 Clariant, 17 Corel Pharma Chem, 6 DFE Pharma, 3 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 37 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Lubrizol Life Science Health, 15 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 32 Roquette, 14 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

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82 Fillers, Diluents & Binders, 49 Coating Systems & Additives, 45 Thickeners and Stabilizers, 43 Direct Compression, 40 Solubilizers, 35 Controlled & Modified Release, 33 Disintegrants & Superdisintegrants, 33 Topical, 27 Granulation, 23 Film Formers & Plasticizers, 21 Parenteral, 20 Lubricants & Glidants, 19 Co-Processed Excipients, 18 Taste Masking, 11 Chewable & Orodispersible Aids, 9 Empty Capsules, 8 Emulsifying Agents, 5 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 1 Soft Gelatin

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9 US Patents, 5 Health Canada Patents

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4 EDQM, 2 USP, 11 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 205223 / DOSAGE - GEL;VAGINAL - 1.3%

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METRONIDAZOLE(UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)	METRONIDAZOLE	65mg in 5

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Allergan, Inc.
BENZYL ALCOHOL(LKG8494WBH)
METHYLPARABEN(A2I8C7HI9T)
POLYCARBOPHIL(W25LM17A4W)
POLYETHYLENE GLYCOL 400(B697894SGQ)
PROPYLENE GLYCOL(6DC9Q167V3)
PROPYLPARABEN(Z8IX2SC1OH)
WATER(059QF0KO0R)

Drug Product Composition: Metronidazole

Metronidazole

Metronidazole

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers

16 USDMF

12 CEP/COS

1 JDMF

1 EU WC

14 KDMF

11 NDC API

17 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

16 Drugs in Development

FINISHED DOSAGE FORMULATIONS

389 FDF Dossiers

116 FDA Orange Book

87 Europe

19 Canada

10 Australia

48 South Africa

109 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 500MG/100ML

INJECTABLE;INJECTION - 500MG/100ML

GEL;TOPICAL - 0.75%

GEL;VAGINAL - 0.75%

GEL;VAGINAL - 1.3%

CREAM;TOPICAL - 0.75%

SUSPENSION;ORAL - 500MG/5ML

GEL;TOPICAL - 1%

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

6 SPI Pharma

2 Seqens

11 DKSH

1 Jai Radhe Sales

4 Faran Shimi Pharmaceutical

5 Boai NKY Pharmaceuticals Ltd

14 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

4 ACG Worldwide

12 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

29 BASF

1 Clariant

17 Corel Pharma Chem

6 DFE Pharma

3 Finar

11 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

37 Kerry

3 Kima Chemical

6 Lonza Capsugel

8 Lubrizol Life Science Health

15 Microlex e.U

1 Nanjing Bold Chemical

2 Nomisma Healthcare

3 Novo Excipients

4 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

32 Roquette

14 Seppic

4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

2 The Dow Chemical Company

TABLET;ORAL - 250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons