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

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Ropinirole Hydrochloride
Europe

Evonik

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Fishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

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xyz-pharma-m-2024-10-07

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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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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xyz-pharma-m-2024-10-07

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Ropinirole Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

19 API Suppliers, 11 USDMF, 6 CEP/COS, 4 JDMF, 6 EU WC, 5 KDMF, 10 NDC API, 11 Listed Suppliers, $ API Reference Price

19 API Suppliers
11 USDMF
6 CEP/COS
4 JDMF
6 EU WC
5 KDMF
10 NDC API
11 Listed Suppliers
$ API Reference Price

INTERMEDIATES

3 API Suppliers

3 API Suppliers

FINISHED DOSAGE FORMULATIONS

222 FDF Dossiers, 138 FDA Orange Book, 60 Europe, 12 Canada, 5 South Africa, 7 Listed Dossiers

222 FDF Dossiers
138 FDA Orange Book
60 Europe
12 Canada
5 South Africa
7 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 17 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 23 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 11 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 17 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

96 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 43 Direct Compression, 36 Controlled & Modified Release, 31 Solubilizers, 30 Thickeners and Stabilizers, 27 Granulation, 23 Disintegrants & Superdisintegrants, 21 Film Formers & Plasticizers, 21 Co-Processed Excipients, 21 Taste Masking, 19 Parenteral, 18 Lubricants & Glidants, 16 Topical, 16 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 8 Rheology Modifiers, 8 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

96 Fillers, Diluents & Binders
55 Coating Systems & Additives
43 Direct Compression
36 Controlled & Modified Release
31 Solubilizers
30 Thickeners and Stabilizers
27 Granulation
23 Disintegrants & Superdisintegrants
21 Film Formers & Plasticizers
21 Co-Processed Excipients
21 Taste Masking
19 Parenteral
18 Lubricants & Glidants
16 Topical
16 Chewable & Orodispersible Aids
11 Emulsifying Agents
8 Rheology Modifiers
8 API Stability Enhancers
5 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 1 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 53 Finished Drug Prices

1 US Medicaid Prescriptions
53 Finished Drug Prices

MARKET PLACE

3 APIs

3 APIs

PATENTS & EXCLUSIVITIES

18 Health Canada Patents

18 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 2 Others

1 USP
2 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 4,415 Xls

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60 All

01 2AUROBINDO PHARMA ITALIA Srl

02 3DOC GENERICI Srl

03 8EG SpA

04 3GlaxoSmithKline

05 12GlaxoSmithKline AB

06 3KRKA D.D.NOVO MESTO

07 3KRKA Sverige AB

08 8LABORATOIRE GLAXOSMITHKLINE

09 5MYLAN SpA

10 3SANDOZ SpA

11 1STADA Arzneimittel AG

12 3Sandoz A/S,

13 3TEVA ITALIA Srl

14 3Teva Sweden AB

filter Active Ingredients Reset all filters

60 All

01 35Ropinirole Hydrochloride

02 25ropinirolhydroklorid

filter Dosage Form Reset all filters

60 All

01 12DEPOTTABLETT

02 3FILM COATED PILL

03 10FILMDRAGERAD TABLETT

04 3Ropinirol 0.25Mg 21 Combined Oral Use

05 3Ropinirol 0.5Mg 21 Combined Oral Use

06 3Ropinirol 1Mg 21 Combined Oral Use

07 3Ropinirol 2Mg 21 Combined Oral Use

08 6Ropinirol 2Mg 28 Combined Oral Use Rp

09 7Ropinirol 4Mg 28 Combined Oral Use Rp

10 3Ropinirol 5Mg 21 Combined Oral Use

11 7Ropinirol 8Mg 28 Combined Oral Use Rp

filter Country Reset all filters

60 All

01 35Italy

02 25Sweden

filter Brand Name Reset all filters

60 All

01 3ADARTREL

02 8Reqp

03 5Requip

04 3Requip Depot

05 27Ropinirol

06 3Ropinirol Krka

07 3Ropinirol Sandoz

08 1Ropinirol Stada

09 3Ropinirole Teva

10 4Vunexin

List of Suppliers

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01

GlaxoSmithKline

2024 ACI Convention

Not Confirmed

GlaxoSmithKline

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Regulatory Info :

Registration Country : Sweden

ropinirolhydroklorid

Brand Name : ADARTREL

Dosage Form : FILM COATED PILL

Dosage Strength : 0.5 MG

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Registration Country : Sweden

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GlaxoSmithKline

2024 ACI Convention

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Registration Country : Sweden

ropinirolhydroklorid

Brand Name : ADARTREL

Dosage Form : FILM COATED PILL

Dosage Strength : 0.25 MG

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Registration Country : Sweden

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03

GlaxoSmithKline

2024 ACI Convention

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GlaxoSmithKline

2024 ACI Convention

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Regulatory Info :

Registration Country : Sweden

ropinirolhydroklorid

Brand Name : ADARTREL

Dosage Form : FILM COATED PILL

Dosage Strength : 2 MG

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Registration Country : Sweden

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04

GlaxoSmithKline AB

2024 ACI Convention

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GlaxoSmithKline AB

2024 ACI Convention

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Regulatory Info :

Registration Country : Sweden

ropinirolhydroklorid

Brand Name : Requip

Dosage Form : FILMDRAGERAD TABLETT

Dosage Strength : 0,5 MG

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Registration Country : Sweden

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05

GlaxoSmithKline AB

2024 ACI Convention

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GlaxoSmithKline AB

2024 ACI Convention

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Regulatory Info :

Registration Country : Sweden

ropinirolhydroklorid

Brand Name : Requip

Dosage Form : FILMDRAGERAD TABLETT

Dosage Strength : 2 MG

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Application Number :

Regulatory Info :

Registration Country : Sweden

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06

GlaxoSmithKline AB

2024 ACI Convention

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GlaxoSmithKline AB

2024 ACI Convention

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Regulatory Info :

Registration Country : Sweden

ropinirolhydroklorid

Brand Name : Requip

Dosage Form : FILMDRAGERAD TABLETT

Dosage Strength : 0,25 MG

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Regulatory Info :

Registration Country : Sweden

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07

GlaxoSmithKline AB

2024 ACI Convention

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GlaxoSmithKline AB

2024 ACI Convention

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Regulatory Info :

Registration Country : Sweden

ropinirolhydroklorid

Brand Name : Requip

Dosage Form : FILMDRAGERAD TABLETT

Dosage Strength : 1 MG

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Registration Country : Sweden

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GlaxoSmithKline AB

2024 ACI Convention

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GlaxoSmithKline AB

2024 ACI Convention

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Regulatory Info :

Registration Country : Sweden

ropinirolhydroklorid

Brand Name : Requip

Dosage Form : FILMDRAGERAD TABLETT

Dosage Strength : 5 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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09

GlaxoSmithKline AB

2024 ACI Convention

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GlaxoSmithKline AB

2024 ACI Convention

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Regulatory Info :

Registration Country : Sweden

ropinirolhydroklorid

Brand Name : Requip Depot

Dosage Form : DEPOTTABLETT

Dosage Strength : 2 MG

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Registration Country : Sweden

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10

GlaxoSmithKline AB

2024 ACI Convention

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GlaxoSmithKline AB

2024 ACI Convention

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Registration Country : Sweden

ropinirolhydroklorid

Brand Name : Requip Depot

Dosage Form : DEPOTTABLETT

Dosage Strength : 4 MG

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