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Approved Drug Products containing Itraconazole listed in the FDA Orange Book. Original Data : FDA Website

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Product

Itraconazole
CAS 115897-54-6
CAS 67914-86-7
CAS 252964-68-4
FDA Orange Book

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Itraconazole

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

78 API Suppliers, 16 USDMF, 18 CEP/COS, 5 JDMF, 20 EU WC, 27 KDMF, 19 NDC API, 52 Listed Suppliers, $ API Reference Price

78 API Suppliers
16 USDMF
18 CEP/COS
5 JDMF
20 EU WC
27 KDMF
19 NDC API
52 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

20 API Suppliers

20 API Suppliers

FINISHED DOSAGE FORMULATIONS

181 FDF Dossiers, 20 FDA Orange Book, 68 Europe, 5 Canada, 4 Australia, 13 South Africa, 71 Listed Dossiers

181 FDF Dossiers
20 FDA Orange Book
68 Europe
5 Canada
4 Australia
13 South Africa
71 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 100MG, TABLET;ORAL - 200MG

CAPSULE;ORAL - 100MG
TABLET;ORAL - 200MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 9 DKSH, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 24 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 16 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 29 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 9 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 30 Controlled & Modified Release, 29 Thickeners and Stabilizers, 28 Direct Compression, 20 Taste Masking, 18 Granulation, 18 Solubilizers, 18 Film Formers & Plasticizers, 15 Lubricants & Glidants, 14 Parenteral, 14 Co-Processed Excipients, 12 Disintegrants & Superdisintegrants, 12 Topical, 9 Empty Capsules, 8 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents, 1 Soft Gelatin

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

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 34 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
34 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 63 Finished Drug Prices

2 US Medicaid Prescriptions
63 Finished Drug Prices

MARKET PLACE

37 APIs, 7 FDF Dossiers

37 APIs
7 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents, 4 Health Canada Patents

6 US Patents
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 10 Others

2 EDQM
2 USP
10 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 80 Xls

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20 All

01 1STRIDES PHARMA

02 1ACCORD HLTHCARE

03 1ALEMBIC

04 1ALKEM LABS LTD

05 2AMNEAL PHARMS

06 1ANNORA PHARMA

07 1APOTEX

08 1JANSSEN PHARMA

09 3JANSSEN PHARMS

10 1JUBILANT GENERICS

11 1MAYNE PHARMA

12 1MYLAN PHARMS INC

13 1RISING PHARMA

14 1SANDOZ

15 1SEBELA IRELAND LTD

16 1TORRENT

17 1ZYDUS PHARMS

filter Dosage Reset all filters

20 All

01 1CAPSULE; ORAL

02 13CAPSULE;ORAL

03 1INJECTABLE;INJECTION

04 4SOLUTION;ORAL

05 1TABLET;ORAL

filter Regulatory Info Reset all filters

20 All

01 8DISCN

02 11RX

03 1Blank

filter Brand Name Reset all filters

20 All

01 14ITRACONAZOLE

02 1ONMEL

03 4SPORANOX

04 1TOLSURA

filter RLD Reset all filters

20 All

01 15No

02 4Yes

03 1Blank

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
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Product Main Page

01

STRIDES PHARMA

CPhI Worldwide, Milan

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content

RLD : No

TE Code :

ITRACONAZOLE

Brand Name : ITRACONAZOLE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2019-07-02

Application Number : 206410

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Strides Pharma Science

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02

JANSSEN PHARMS

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RLD : Yes

TE Code : AB

ITRACONAZOLE

Brand Name : SPORANOX

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 1992-09-11

Application Number : 20083

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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03

JANSSEN PHARMS

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RLD : Yes

TE Code : AA

ITRACONAZOLE

Brand Name : SPORANOX

Dosage Form : SOLUTION;ORAL

Dosage Strength : 10MG/ML

Approval Date : 1997-02-21

Application Number : 20657

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AA

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RLD :

TE Code :

ITRACONAZOLE

Brand Name : SPORANOX

Dosage Form : CAPSULE; ORAL

Dosage Strength : 100MG

Approval Date :

Application Number : 20694

RX/OTC/DISCN :

RLD :

TE Code :

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05

JANSSEN PHARMS

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RLD : No

TE Code :

ITRACONAZOLE

Brand Name : SPORANOX

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 10MG/ML

Approval Date : 1999-03-30

Application Number : 20966

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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06

JUBILANT GENERICS

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Digital Content

RLD : No

TE Code :

ITRACONAZOLE

Brand Name : ITRACONAZOLE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2017-02-23

Application Number : 203445

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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07

SANDOZ

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SANDOZ

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RLD : No

TE Code : AB

ITRACONAZOLE

Brand Name : ITRACONAZOLE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2004-05-28

Application Number : 76104

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Digital Content

08

SEBELA IRELAND LTD

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RLD : Yes

TE Code :

ITRACONAZOLE

Brand Name : ONMEL

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2010-04-29

Application Number : 22484

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

MYLAN PHARMS INC

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MYLAN PHARMS INC

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Digital Content

RLD : No

TE Code :

ITRACONAZOLE

Brand Name : ITRACONAZOLE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2012-07-20

Application Number : 200463

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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10

ZYDUS PHARMS

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RLD : No

TE Code : AB

ITRACONAZOLE

Brand Name : ITRACONAZOLE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 100MG

Approval Date : 2017-09-19

Application Number : 204672

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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