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Nilotinib
FDA Orange Book

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Nilotinib

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

60 API Suppliers, 23 USDMF, 3 CEP/COS, 1 JDMF, 9 EU WC, 7 KDMF, 15 NDC API, 33 Listed Suppliers, $ API Reference Price

60 API Suppliers
23 USDMF
3 CEP/COS
1 JDMF
9 EU WC
7 KDMF
15 NDC API
33 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

5 Drugs in Development

5 Drugs in Development

INTERMEDIATES

38 Intermediate Suppliers

38 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

60 FDF Dossiers, 16 FDA Orange Book, 6 Europe, 4 Canada, 7 Australia, 4 South Africa, 23 Listed Dossiers

60 FDF Dossiers
16 FDA Orange Book
6 Europe
4 Canada
7 Australia
4 South Africa
23 Listed Dossiers

RELATED EXCIPIENT COMPANIES

7 DKSH, 2 Faran Shimi Pharmaceutical, 2 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 2 DFE Pharma, 2 Gangwal Chemicals, 14 Kerry, 3 Lonza Capsugel, 7 Microlex e.U, 1 Nanjing Bold Chemical, 2 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 2 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 2 Sigachi Industries, 1 Silverline Chemicals, 1 Vasa Pharmachem

7 DKSH
2 Faran Shimi Pharmaceutical
2 Gangwal Healthcare
2 Nanjing Well Pharmaceutical
4 ACG Worldwide
2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
1 BASF
2 DFE Pharma
2 Gangwal Chemicals
14 Kerry
3 Lonza Capsugel
7 Microlex e.U
1 Nanjing Bold Chemical
2 Pluviaendo
1 Prachin Chemical
1 Qualicaps
2 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
2 Sigachi Industries
1 Silverline Chemicals
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

28 Fillers, Diluents & Binders, 10 Lubricants & Glidants, 8 Empty Capsules, 7 Thickeners and Stabilizers, 5 Granulation, 5 Direct Compression, 5 Coating Systems & Additives, 4 Co-Processed Excipients, 4 Emulsifying Agents, 3 Film Formers & Plasticizers, 2 Parenteral, 2 Coloring Agents, 1 Topical, 1 Taste Masking, 1 API Stability Enhancers, 1 Solubilizers

28 Fillers, Diluents & Binders
10 Lubricants & Glidants
8 Empty Capsules
7 Thickeners and Stabilizers
5 Granulation
5 Direct Compression
5 Coating Systems & Additives
4 Co-Processed Excipients
4 Emulsifying Agents
3 Film Formers & Plasticizers
2 Parenteral
2 Coloring Agents
1 Topical
1 Taste Masking
1 API Stability Enhancers
1 Solubilizers

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 1 Stock Recap #PipelineProspector, 43 News #PharmaBuzz

2 Data Compilation #PharmaFlow
1 Stock Recap #PipelineProspector
43 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Regulatory FDF Prices, 11 Annual Reports

1 US Medicaid Prescriptions
3 Regulatory FDF Prices
11 Annual Reports

MARKET PLACE

9 APIs, 9 FDF Dossiers

9 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

46 US Patents, 18 US Exclusivities, 6 Health Canada Patents

46 US Patents
18 US Exclusivities
6 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 Others

5 Others

$ API Ref.Price (USD/KG) : 4,208 Xls

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16 All

01 3APOTEX

02 2AZURITY

03 3CIPLA

04 3HETERO LABS LIMITED

05 2MSN LABORATORIES PRIVATE LTD

06 3NOVARTIS

filter Dosage Reset all filters

16 All

01 3CAPSULE

02 11CAPSULE;ORAL

03 2TABLET;ORAL

filter Regulatory Info Reset all filters

16 All

01 11RX

02 5Blank

filter Brand Name Reset all filters

16 All

01 2DANZITEN

02 2NILOTINIB

03 3NILOTINIB D-TARTRATE

04 3NILOTINIB HYDROCHLORIDE

05 3NILOTINIB HYDROCHLORIDE DIHYDRATE

06 3TASIGNA

filter RLD Reset all filters

16 All

01 3No

02 8Yes

03 5Blank

List of Suppliers

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01

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APOTEX

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Digital Content

RLD : No

TE Code : AB

NILOTINIB HYDROCHLORIDE

Brand Name : NILOTINIB HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 2024-01-05

Application Number : 203640

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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Digital Content

Corporate PDF

02

APOTEX

FCE Pharma

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Digital Content

RLD : No

TE Code : AB

NILOTINIB HYDROCHLORIDE

Brand Name : NILOTINIB HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2024-01-05

Application Number : 203640

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

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Digital Content

Corporate PDF

03

APOTEX

FCE Pharma

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Digital Content

RLD : No

TE Code : AB

NILOTINIB HYDROCHLORIDE

Brand Name : NILOTINIB HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 2024-01-05

Application Number : 203640

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

HETERO LABS LIMITED

FCE Pharma

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HETERO LABS LIMITED

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RLD :

TE Code :

NILOTINIB HYDROCHLORIDE DIHYDRATE

Brand Name : NILOTINIB HYDROCHLORIDE DIHYDRATE

Dosage Form : CAPSULE

Dosage Strength : 200MG

Approval Date :

Application Number : 209651

RX/OTC/DISCN :

RLD :

TE Code :

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05

HETERO LABS LIMITED

FCE Pharma

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HETERO LABS LIMITED

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RLD :

TE Code :

NILOTINIB HYDROCHLORIDE DIHYDRATE

Brand Name : NILOTINIB HYDROCHLORIDE DIHYDRATE

Dosage Form : CAPSULE

Dosage Strength : 50MG

Approval Date :

Application Number : 209651

RX/OTC/DISCN :

RLD :

TE Code :

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06

HETERO LABS LIMITED

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RLD :

TE Code :

NILOTINIB HYDROCHLORIDE DIHYDRATE

Brand Name : NILOTINIB HYDROCHLORIDE DIHYDRATE

Dosage Form : CAPSULE

Dosage Strength : 150MG

Approval Date :

Application Number : 209651

RX/OTC/DISCN :

RLD :

TE Code :

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07

MSN LABORATORIES PRIVATE LTD

FCE Pharma

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RLD :

TE Code :

Brand Name : NILOTINIB

Dosage Form : CAPSULE;ORAL

Dosage Strength : 150MG

Approval Date :

Application Number : 218544

RX/OTC/DISCN :

RLD :

TE Code :

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08

NOVARTIS

FCE Pharma

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NOVARTIS

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RLD : Yes

TE Code : AB

NILOTINIB HYDROCHLORIDE

Brand Name : TASIGNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 2007-10-29

Application Number : 22068

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

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09

NOVARTIS

FCE Pharma

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NOVARTIS

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Digital Content

RLD : Yes

TE Code : AB

NILOTINIB HYDROCHLORIDE

Brand Name : TASIGNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2010-06-17

Application Number : 22068

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

NOVARTIS

FCE Pharma

Not Confirmed

NOVARTIS

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RLD : Yes

TE Code : AB

NILOTINIB HYDROCHLORIDE

Brand Name : TASIGNA

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 2018-03-22

Application Number : 22068

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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Digital Content

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