Lidocaine

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ACTIVE PHARMA INGREDIENTS

49 API Suppliers, 18 USDMF, 6 CEP/COS, 5 JDMF, 10 EU WC, 8 KDMF, 24 NDC API, 31 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

32 Drugs in Development

32 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

263 FDF Dossiers, 51 FDA Orange Book, 121 Europe, 19 Canada, 3 Australia, 14 South Africa, 55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, PATCH;TOPICAL - 5%, PATCH;TOPICAL - 70MG;70MG, CREAM;TOPICAL - 7%;7%

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Evonik, 3 Rochem International Inc, 12 SPI Pharma, 3 Seqens, 18 DKSH, 2 Jai Radhe Sales, 1 PMC Isochem, 2 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 9 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 2 Kewpie Corporation, 23 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 17 Actylis, 3 Aeon Procare, 2 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 52 BASF, 1 Bioplus Life Sciences, 1 BioSpectra, 3 Clariant, 13 Corel Pharma Chem, 1 DFE Pharma, 3 Doshion Polyscience, 5 Finar, 18 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 2 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 11 Kerry, 1 Kima Chemical, 3 Lonza Capsugel, 8 Lubrizol Life Science Health, 17 Microlex e.U, 4 Nanjing Bold Chemical, 3 Nippon Fine Chemical, 2 Nomisma Healthcare, 4 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 19 Roquette, 16 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 4 Sigachi Industries, 1 The Dow Chemical Company, 3 Ulanqab Kema New Material, 2 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

84 Topical, 72 Solubilizers, 62 Fillers, Diluents & Binders, 50 Thickeners and Stabilizers, 42 Parenteral, 37 Direct Compression, 34 Emulsifying Agents, 33 Coating Systems & Additives, 31 Disintegrants & Superdisintegrants, 29 Film Formers & Plasticizers, 25 Lubricants & Glidants, 25 Granulation, 22 Surfactant & Foaming Agents, 20 Co-Processed Excipients, 19 Controlled & Modified Release, 18 Taste Masking, 12 Rheology Modifiers, 11 Chewable & Orodispersible Aids, 8 Empty Capsules, 7 API Stability Enhancers, 2 Coloring Agents, 1 Dry Powder Inhalation, 1 Soft Gelatin

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5 US Medicaid Prescriptions, 78 Finished Drug Prices, 1 Annual Reports

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31 APIs, 23 FDF Dossiers

PATENTS & EXCLUSIVITIES

11 US Patents, 1 Health Canada Patents

REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 21623 / DOSAGE - PATCH;TOPICAL - 70MG;70MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE(UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	70mg
TETRACAINE(UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE	70mg

Inactive Ingredients

Ingredient Name	Galen US Incorporated	ZARS Pharma, Inc.
METHYLPARABEN(A2I8C7HI9T)
POLYVINYL ALCOHOL(532B59J990)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
PROPYLPARABEN(Z8IX2SC1OH)
SORBITAN MONOPALMITATE(77K6Z421KU)
WATER(059QF0KO0R)

Drug Product Composition: Lidocaine

Lidocaine

Lidocaine

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

49 API Suppliers

18 USDMF

6 CEP/COS

5 JDMF

10 EU WC

8 KDMF

24 NDC API

31 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

32 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

263 FDF Dossiers

51 FDA Orange Book

121 Europe

19 Canada

3 Australia

14 South Africa

55 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CREAM;TOPICAL - 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

PATCH;TOPICAL - 5%

PATCH;TOPICAL - 70MG;70MG

CREAM;TOPICAL - 7%;7%

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Evonik

3 Rochem International Inc

12 SPI Pharma

3 Seqens

18 DKSH

2 Jai Radhe Sales

1 PMC Isochem

2 Pharm-RX Chemical

6 Faran Shimi Pharmaceutical

9 Boai NKY Pharmaceuticals Ltd

9 Gangwal Healthcare

2 Kewpie Corporation

23 Nanjing Well Pharmaceutical

2 Pfanstiehl

4 ACG Worldwide

17 Actylis

3 Aeon Procare

2 Alcedo Pharmachem

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

52 BASF

1 Bioplus Life Sciences

1 BioSpectra

3 Clariant

13 Corel Pharma Chem

1 DFE Pharma

3 Doshion Polyscience

5 Finar

18 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

2 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

11 Kerry

1 Kima Chemical

3 Lonza Capsugel

8 Lubrizol Life Science Health

17 Microlex e.U

4 Nanjing Bold Chemical

3 Nippon Fine Chemical

2 Nomisma Healthcare

4 Novo Excipients

2 Pharmatrans-Sanaq

7 Pluviaendo

3 Prachin Chemical

1 Qualicaps

CREAM;TOPICAL - 2.5%;2.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons