Rocuronium Bromide | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Rocuronium Bromide
South Africa

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Rocuronium Bromide

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ACTIVE PHARMA INGREDIENTS

36 API Suppliers, 13 USDMF, 9 CEP/COS, 3 JDMF, 2 EU WC, 4 KDMF, 10 NDC API, 28 Listed Suppliers, $ API Reference Price

36 API Suppliers
13 USDMF
9 CEP/COS
3 JDMF
2 EU WC
4 KDMF
10 NDC API
28 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

18 Intermediates Suppliers

18 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

95 FDF Dossiers, 37 FDA Orange Book, 19 Europe, 7 Canada, 11 South Africa, 21 Listed Dossiers

95 FDF Dossiers
37 FDA Orange Book
19 Europe
7 Canada
11 South Africa
21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 Actylis

2 Actylis

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 25 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
25 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 Finished Drug Prices

6 Finished Drug Prices

MARKET PLACE

16 APIs, 17 FDF Dossiers

16 APIs
17 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 2 USP, 12 Others

2 EDQM
2 USP
12 Others

$ API Ref.Price (USD/KG) : 16,688 Xls

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11 All

01 1Sanofi Aventis South Africa (Pty) Ltd

02 2Abex Pharmaceutica (Pty) Ltd

03 2Adcock Ingram Limited

04 1Biotech Laboratories (Pty) Ltd

05 2Fresenius Kabi South Africa (Pty) Ltd

06 1Kahma Biotech (Pty) Ltd

07 1MSD (Pty) Ltd

08 1Pharma Dynamics (Pty) Ltd

filter Active Ingredients Reset all filters

11 All

01 7Rocuronium Bromide

02 4Rocuronium bromide

filter Dosage Form Reset all filters

11 All

01 10INJ

02 1SLT

filter Brand Name Reset all filters

11 All

01 2ADCO ROCURONIUM 50mg

02 1Erunom

03 1Esmeron

04 1Esmeron 50 mg

05 1MERAXT 10mg/ml

06 1ROCURONIUM 50 IV BIOTECH

07 2ROCURONIUM FRESENIUS 10 mg/ml (50 mg/5 ml)

08 1RONIA

09 1Trakeze

Synnat Rocuronium Bromide

List of Suppliers

Product Main Page

01

Sanofi Aventis South Africa (Pty) Ltd

PharmaVenue

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Rocuronium bromide

Brand Name : Esmeron

Dosage Form : INJ

Dosage Strength : 50mg/5ml

Packaging : 5X10mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner

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Product Web Link

Digital Content

02

Abex Pharmaceutica (Pty) Ltd

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Abex Pharmaceutica (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium bromide

Brand Name : RONIA

Dosage Form : INJ

Dosage Strength : 50mg/5 ml

Packaging : 5X10mg/5 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Abex Pharmaceutica (Pty) Ltd

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Abex Pharmaceutica (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium bromide

Brand Name : Erunom

Dosage Form : INJ

Dosage Strength : 50mg/5 ml

Packaging : 5X10mg/5 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Corporate PDF

04

Adcock Ingram Limited

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium Bromide

Brand Name : ADCO ROCURONIUM 50mg

Dosage Form : INJ

Dosage Strength : 50mg/ 5ml

Packaging : 5X10mg/ 5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Adcock Ingram Limited

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Adcock Ingram Limited

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium Bromide

Brand Name : ADCO ROCURONIUM 50mg

Dosage Form : INJ

Dosage Strength : 50mg/ 5ml

Packaging : 5X10mg/ 5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Biotech Laboratories (Pty) Ltd

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Biotech Laboratories (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium Bromide

Brand Name : ROCURONIUM 50 IV BIOTECH

Dosage Form : INJ

Dosage Strength : 50mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Fresenius Kabi South Africa (Pty) Ltd

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Fresenius Kabi South Africa (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium Bromide

Brand Name : ROCURONIUM FRESENIUS 10 mg/ml (50 mg/5 ml)

Dosage Form : INJ

Dosage Strength : 50mg/5 ml

Packaging : 5X1mg/5 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Fresenius Kabi South Africa (Pty) Ltd

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Fresenius Kabi South Africa (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium Bromide

Brand Name : ROCURONIUM FRESENIUS 10 mg/ml (50 mg/5 ml)

Dosage Form : INJ

Dosage Strength : 50mg/5 ml

Packaging : 5X10mg/5 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Kahma Biotech (Pty) Ltd

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Kahma Biotech (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium Bromide

Brand Name : MERAXT 10mg/ml

Dosage Form : INJ

Dosage Strength : 50mg/5ml

Packaging : 10X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

MSD (Pty) Ltd

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Not Confirmed

MSD (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Rocuronium Bromide

Brand Name : Esmeron 50 mg

Dosage Form : SLT

Dosage Strength : 50mg/5ml

Packaging : 5X10mg/5ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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