Melphalan Hydrochloride | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Melphalan Hydrochloride
Europe

Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.

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Melphalan Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 11 USDMF, 4 EU WC, 3 KDMF, 13 NDC API, 14 Listed Suppliers, $ API Reference Price

22 API Suppliers
11 USDMF
4 EU WC
3 KDMF
13 NDC API
14 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

12 Drugs in Development

12 Drugs in Development

FINISHED DOSAGE FORMULATIONS

35 FDF Dossiers, 22 FDA Orange Book, 4 Europe, 6 Canada, 2 South Africa, 1 Listed Dossiers

35 FDF Dossiers
22 FDA Orange Book
4 Europe
6 Canada
2 South Africa
1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAVENOUS - EQ 50MG BASE/VIAL

INJECTABLE;INJECTION - EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
POWDER;INTRAVENOUS - EQ 50MG BASE/VIAL

RELATED EXCIPIENT COMPANIES

1 Panvo Organics, 1 CD Formulation, 1 Gangwal Chemicals

1 Panvo Organics
1 CD Formulation
1 Gangwal Chemicals

EXCIPIENTS BY APPLICATIONS

2 Thickeners and Stabilizers, 2 Parenteral, 2 Solubilizers, 1 Dry Powder Inhalation, 1 Fillers, Diluents & Binders, 1 Taste Masking, 1 Emulsifying Agents

2 Thickeners and Stabilizers
2 Parenteral
2 Solubilizers
1 Dry Powder Inhalation
1 Fillers, Diluents & Binders
1 Taste Masking
1 Emulsifying Agents

DIGITAL CONTENT

16 News #PharmaBuzz

16 News #PharmaBuzz

MARKET PLACE

2 APIs, 1 FDF Dossiers

2 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

19 US Patents, 2 US Exclusivities

19 US Patents
2 US Exclusivities

REF. STANDARDS & IMPURITIES

1 EDQM, 1 Others

1 EDQM
1 Others

$ API Ref.Price (USD/KG) : 77,232 Xls

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8 All

01 2Adienne S.R.L. S.U.

02 1Hikma Farmaceutica (Portugal) Sa

03 1Macure Pharma ApS

04 1Macure Pharma Aps

05 1Sun Pharmaceutical Industries Europe Bv

06 1Tarbis Farma Sl

07 1Zentiva Ks

filter Active Ingredients Reset all filters

8 All

01 7Melphalan Hydrochloride

02 1Melphalan hydrochloride

filter Dosage Form Reset all filters

8 All

01 3Injection/Infusion Solution

02 2Powder And Solvent For Concentrate For Infusion Solution

03 3Powder And Solvent For Injection And Infusion Solution

filter Country Reset all filters

8 All

01 4Denmark

02 1Norway

03 3Spain

filter Brand Name Reset all filters

8 All

01 1Melfalan Hikma

02 1Melfalan Tarbis

03 1Melfalan Zentiva

04 1Melphalan Macure

05 1Melphalan "Macure"

06 1Melphalan "Sun"

07 2Phelinun

List of Suppliers

Product Main Page

01

Adienne S.R.L. S.U.

SCOPE Summit

Not Confirmed

Adienne S.R.L. S.U.

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Prescription

Registration Country : Denmark

Melphalan Hydrochloride

Brand Name : Phelinun

Dosage Form : Powder And Solvent For Concentrate For Infusion Solution

Dosage Strength : 200mg

Packaging :

Approval Date : 16-11-2020

Application Number : 28106247219

Regulatory Info : Prescription

Registration Country : Denmark

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Adienne S.R.L. S.U.

SCOPE Summit

Not Confirmed

Adienne S.R.L. S.U.

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Prescription

Registration Country : Denmark

Melphalan Hydrochloride

Brand Name : Phelinun

Dosage Form : Powder And Solvent For Concentrate For Infusion Solution

Dosage Strength : 50mg

Packaging :

Approval Date : 16-11-2020

Application Number : 28106247119

Regulatory Info : Prescription

Registration Country : Denmark

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Hikma Farmaceutica (Portugal) Sa

SCOPE Summit

Not Confirmed

Hikma Farmaceutica (Portugal) Sa

SCOPE Summit

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Melphalan Hydrochloride

Brand Name : Melfalan Hikma

Dosage Form : Powder And Solvent For Injection And Infusion Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 05-04-2023

Application Number : 88763

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Macure Pharma ApS

SCOPE Summit

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Macure Pharma ApS

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Digital Content

Regulatory Info : Marketed

Registration Country : Norway

Melphalan hydrochloride

Brand Name : Melphalan Macure

Dosage Form : Injection/Infusion Solution

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info : Marketed

Registration Country : Norway

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05

Macure Pharma Aps

SCOPE Summit

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Macure Pharma Aps

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Digital Content

Regulatory Info : Prescription

Registration Country : Denmark

Melphalan Hydrochloride

Brand Name : Melphalan \"Macure\"

Dosage Form : Injection/Infusion Solution

Dosage Strength : 50mg

Packaging :

Approval Date : 09-04-2019

Application Number : 28106100018

Regulatory Info : Prescription

Registration Country : Denmark

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Sun Pharmaceutical Industries Europe Bv

SCOPE Summit

Not Confirmed

Sun Pharmaceutical Industries Europe Bv

SCOPE Summit

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Digital Content

Regulatory Info : Prescription

Registration Country : Denmark

Melphalan Hydrochloride

Brand Name : Melphalan \"Sun\"

Dosage Form : Injection/Infusion Solution

Dosage Strength : 50mg

Packaging :

Approval Date : 03-03-2020

Application Number : 28106346519

Regulatory Info : Prescription

Registration Country : Denmark

Portfolio PDF

Product Web Link

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07

Zentiva Ks

SCOPE Summit

Not Confirmed

Zentiva Ks

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Melphalan Hydrochloride

Brand Name : Melfalan Zentiva

Dosage Form : Powder And Solvent For Injection And Infusion Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 01-06-2017

Application Number : 82087

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Tarbis Farma Sl

Country

SCOPE Summit

Not Confirmed

Tarbis Farma Sl

Country

SCOPE Summit

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Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Country

Virtual Booth

Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Melphalan Hydrochloride

Brand Name : Melfalan Tarbis

Dosage Form : Powder And Solvent For Injection And Infusion Solution

Dosage Strength : 50MG

Packaging :

Approval Date : 08-10-2021

Application Number : 86295

Regulatory Info : Authorized

Registration Country : Spain

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.