Nilotinib hydrochloride anhydrous | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Nilotinib Hydrochloride Anhydrous
FDA Orange Book

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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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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Nilotinib hydrochloride anhydrous

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

47 API Suppliers, 22 USDMF, 3 CEP/COS, 1 JDMF, 7 EU WC, 5 KDMF, 15 NDC API, 33 Listed Suppliers, $ API Reference Price

47 API Suppliers
22 USDMF
3 CEP/COS
1 JDMF
7 EU WC
5 KDMF
15 NDC API
33 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

27 Intermediates Suppliers

27 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

51 FDF Dossiers, 13 FDA Orange Book, 6 Europe, 7 Australia, 2 South Africa, 23 Listed Dossiers

51 FDF Dossiers
13 FDA Orange Book
6 Europe
7 Australia
2 South Africa
23 Listed Dossiers

RELATED EXCIPIENT COMPANIES

7 DKSH, 2 Faran Shimi Pharmaceutical, 4 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, 3 Sigachi Industries, 1 Vasa Pharmachem

7 DKSH
2 Faran Shimi Pharmaceutical
4 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
3 Sigachi Industries
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

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

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

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 1 STOCK RECAP #PipelineProspector, 42 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
1 STOCK RECAP #PipelineProspector
42 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 3 Finished Drug Prices, 10 Annual Reports

1 US Medicaid Prescriptions
3 Finished Drug Prices
10 Annual Reports

MARKET PLACE

9 APIs, 9 FDF Dossiers

9 APIs
9 FDF Dossiers

PATENTS & EXCLUSIVITIES

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

49 US Patents
18 US Exclusivities
6 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 Others

5 Others

$ API Ref.Price (USD/KG) : 4,825 Xls

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01 3APOTEX

02 2AZURITY

03 3HETERO LABS LIMITED

04 2MSN LABORATORIES PRIVATE LTD

05 3NOVARTIS

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13 All

01 3CAPSULE

02 8CAPSULE;ORAL

03 2TABLET;ORAL

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01 3DISCN

02 5RX

03 5Blank

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01 2DANZITEN

02 2NILOTINIB

03 3NILOTINIB HYDROCHLORIDE

04 3NILOTINIB HYDROCHLORIDE DIHYDRATE

05 3TASIGNA

filter RLD Reset all filters

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01 3No

02 5Yes

03 5Blank

List of Suppliers

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01

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RLD : No

TE Code :

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 : DISCN

RLD : No

TE Code :

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02

APOTEX

Cosmoprof

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APOTEX

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Digital Content

RLD : No

TE Code :

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 : DISCN

RLD : No

TE Code :

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03

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Digital Content

RLD : No

TE Code :

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 : DISCN

RLD : No

TE Code :

Portfolio PDF

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04

HETERO LABS LIMITED

Cosmoprof

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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

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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

Cosmoprof

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MSN LABORATORIES PRIVATE LTD

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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

Cosmoprof

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NOVARTIS

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RLD : Yes

TE Code :

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 :

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09

NOVARTIS

Cosmoprof

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NOVARTIS

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Digital Content

RLD : Yes

TE Code :

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 :

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10

NOVARTIS

Cosmoprof

Not Confirmed

NOVARTIS

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Digital Content

RLD : Yes

TE Code :

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 :

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