Testosterone

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 22 USDMF, 8 CEP/COS, 6 EU WC, 44 NDC API, 17 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

FINISHED DOSAGE FORMULATIONS

125 FDF Dossiers, 59 FDA Orange Book, 39 Europe, 7 Canada, 7 Australia, 8 South Africa, 5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, FILM, EXTENDED RELEASE;TRANSDERMAL - 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL, METERED;NASAL - 5.5MG/0.122GM ACTUATION, GEL, METERED;TRANSDERMAL - 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TRANSDERMAL - 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TRANSDERMAL - 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, GEL;TRANSDERMAL - 50MG/5GM PACKET, TABLET, EXTENDED RELEASE;BUCCAL - 30MG, GEL, METERED;TRANSDERMAL - 1.62% (20.25MG/1.25GM ACTUATION), GEL;TRANSDERMAL - 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION, METERED;TRANSDERMAL - 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 2 DKSH, 1 Jai Radhe Sales, 6 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 7 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 BioSpectra, 2 Clariant, 15 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 7 Lubrizol Life Science Health, 14 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 3 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

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75 Fillers, Diluents & Binders, 44 Coating Systems & Additives, 35 Topical, 33 Direct Compression, 30 Controlled & Modified Release, 25 Thickeners and Stabilizers, 21 Disintegrants & Superdisintegrants, 21 Granulation, 19 Lubricants & Glidants, 19 Co-Processed Excipients, 16 Solubilizers, 16 Film Formers & Plasticizers, 14 Parenteral, 7 Taste Masking, 6 API Stability Enhancers, 6 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Rheology Modifiers, 2 Coloring Agents

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ANALYTICAL

2 Analytical Methods

2 Analytical Methods

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USFDA APPLICATION NUMBER - 21454 / DOSAGE - GEL;TRANSDERMAL - 50MG/5GM PACKET

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TESTOSTERONE(UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)	TESTOSTERONE	50mg in 5

Inactive Ingredients

Ingredient Name	Bryant Ranch Prepack	Encube Ethicals Private Limited
ALCOHOL(3K9958V90M)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(4Q93RCW27E)
CARBOMER HOMOPOLYMER TYPE C(4Q93RCW27E)
ISOPROPYL MYRISTATE(0RE8K4LNJS)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)

Drug Product Composition: Testosterone

Testosterone

Testosterone

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers

22 USDMF

8 CEP/COS

6 EU WC

44 NDC API

17 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Exports

FDF Imports

FINISHED DOSAGE FORMULATIONS

125 FDF Dossiers

59 FDA Orange Book

39 Europe

7 Canada

7 Australia

8 South Africa

5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FILM, EXTENDED RELEASE;TRANSDERMAL - 2MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FILM, EXTENDED RELEASE;TRANSDERMAL - 4MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL, METERED;NASAL - 5.5MG/0.122GM ACTUATION

GEL, METERED;TRANSDERMAL - 12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;TRANSDERMAL - 25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;TRANSDERMAL - 50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

GEL;TRANSDERMAL - 50MG/5GM PACKET

TABLET, EXTENDED RELEASE;BUCCAL - 30MG

GEL, METERED;TRANSDERMAL - 1.62% (20.25MG/1.25GM ACTUATION)

GEL;TRANSDERMAL - 1.62% (40.5MG/2.5GM PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION, METERED;TRANSDERMAL - 30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

2 Seqens

2 DKSH

1 Jai Radhe Sales

6 Boai NKY Pharmaceuticals Ltd

12 Gangwal Healthcare

7 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

7 Actylis

1 Aeon Procare

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

23 BASF

1 BioSpectra

2 Clariant

15 Corel Pharma Chem

6 DFE Pharma

2 Finar

7 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

36 Kerry

3 Kima Chemical

6 Lonza Capsugel

7 Lubrizol Life Science Health

14 Microlex e.U

2 Nomisma Healthcare

2 Novo Excipients

2 Pharmatrans-Sanaq

7 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

18 Roquette

7 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

FILM, EXTENDED RELEASE;TRANSDERMAL - 2MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

FILM, EXTENDED RELEASE;TRANSDERMAL - 4MG/24HR Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL, METERED;TRANSDERMAL - 12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;TRANSDERMAL - 25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;TRANSDERMAL - 50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

GEL;TRANSDERMAL - 1.62% (40.5MG/2.5GM PACKET) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SOLUTION, METERED;TRANSDERMAL - 30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons