Zemuron, Esmeron, Rocuronium bromide | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Zemuron, Esmeron, Rocuronium Bromide
South Africa

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

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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HealthTech BioActives, leading globally in Flavonoids and Vitamin B12 Derivatives.

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Aspen API. More than just an API™

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FAMAR CDMO- From early development to commercial manufacturing.

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Zemuron, Esmeron, Rocuronium bromide

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 13 USDMF, 11 CEP/COS, 3 JDMF, 3 EU WC, 5 KDMF, 8 NDC API, 29 Listed Suppliers, $ API Reference Price

44 API Suppliers
13 USDMF
11 CEP/COS
3 JDMF
3 EU WC
5 KDMF
8 NDC API
29 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

41 Drugs in Development

41 Drugs in Development

INTERMEDIATES

15 Intermediate Suppliers

15 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

117 FDF Dossiers, 41 FDA Orange Book, 35 Europe, 6 Canada, 12 South Africa, 23 Listed Dossiers

117 FDF Dossiers
41 FDA Orange Book
35 Europe
6 Canada
12 South Africa
23 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INJECTABLE;INJECTION - 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - 100MG/10ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 10MG/ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Kirsch Pharma, 2 Actylis

2 Kirsch Pharma
2 Actylis

DIGITAL CONTENT

25 News #PharmaBuzz

25 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 Regulatory FDF Prices

6 Regulatory FDF Prices

MARKET PLACE

19 APIs, 17 FDF Dossiers

19 APIs
17 FDF Dossiers

REF. STANDARDS & IMPURITIES

2 EDQM, 12 Others

2 EDQM
12 Others

$ API Ref.Price (USD/KG) : 9,894 Xls

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12 All

01 1Sanofi Aventis South Africa (Pty) Ltd

02 1Activo Health (Pty) Ltd

03 1Adcock Ingram Limited

04 1B. Braun Medical (Pty) Ltd

05 1Biotech Laboratories (Pty) Ltd

06 1Cipla Medpro (Pty) Ltd

07 2Fresenius Kabi South Africa (Pty) Ltd

08 1Juno Pharma SA (Pty) Ltd

09 1MSD (Pty) Ltd

10 1Macleods Pharmaceuticals SA (Pty) Ltd

11 1Pharma Dynamics (Pty) Ltd

filter Active Ingredients Reset all filters

12 All

01 6Rocuronium Bromide

02 6Rocuronium bromide

filter Dosage Form Reset all filters

12 All

01 11INJ

02 1SLT

filter Brand Name Reset all filters

12 All

01 1ADCO ROCURONIUM 50 mg

02 1Erunom

03 1Esmeron

04 1Esmeron 50 mg

05 1Immaroc

06 1MERAXT 10mg/ml

07 1ROCURONIUM 50 IV BIOTECH

08 2ROCURONIUM FRESENIUS 10 mg/ml (50 mg/5 ml)

09 1RONIA

10 1Rocuronium 50 mg B. Braun

11 1Trakeze

List of Suppliers

Product Main Page

01

Sanofi Aventis South Africa (Pty) Ltd

CPhI WW Frankfurt

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

Portfolio PDF

Product Web Link

Digital Content

02

Activo Health (Pty) Ltd

PREP

Not Confirmed

Activo Health (Pty) Ltd

PREP

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Adcock Ingram Limited

PREP

Not Confirmed

Adcock Ingram Limited

PREP

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium Bromide

Brand Name : ADCO ROCURONIUM 50 mg

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

04

B. Braun Medical (Pty) Ltd

PREP

Not Confirmed

B. Braun Medical (Pty) Ltd

PREP

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium bromide

Brand Name : Rocuronium 50 mg B. Braun

Dosage Form : INJ

Dosage Strength : 50mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Biotech Laboratories (Pty) Ltd

PREP

Not Confirmed

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

06

Cipla Medpro (Pty) Ltd

PREP

Not Confirmed

Cipla Medpro (Pty) Ltd

PREP

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium bromide

Brand Name : Immaroc

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

07

Fresenius Kabi South Africa (Pty) Ltd

PREP

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

PREP

Not Confirmed

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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

PREP

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

PREP

Not Confirmed

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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

Macleods Pharmaceuticals SA (Pty) Ltd

PREP

Not Confirmed

Macleods Pharmaceuticals SA (Pty) Ltd

PREP

Not Confirmed

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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 : 5X1mg/5 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Juno Pharma SA (Pty) Ltd

Country

PREP

Not Confirmed

Juno Pharma SA (Pty) Ltd

Country

PREP

Not Confirmed

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Country

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Rocuronium Bromide

Brand Name : MERAXT 10mg/ml

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

Virtual Booth

Digital Content

Website

Corporate PDF

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