Ropivacaine Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Ropivacaine Hydrochloride
South Africa

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Ropivacaine Hydrochloride

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 16 USDMF, 10 CEP/COS, 1 JDMF, 12 EU WC, 5 KDMF, 12 NDC API, 37 Listed Suppliers, $ API Reference Price

52 API Suppliers
16 USDMF
10 CEP/COS
1 JDMF
12 EU WC
5 KDMF
12 NDC API
37 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

8 Drugs in Development

8 Drugs in Development

INTERMEDIATES

12 Intermediates Suppliers

12 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

162 FDF Dossiers, 75 FDA Orange Book, 48 Europe, 6 Canada, 11 South Africa, 22 Listed Dossiers

162 FDF Dossiers
75 FDA Orange Book
48 Europe
6 Canada
11 South Africa
22 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INJECTION - 100MG/10ML (10MG/ML), SOLUTION;INJECTION - 100MG/20ML (5MG/ML), SOLUTION;INJECTION - 150MG/30ML (5MG/ML), SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML), SOLUTION;INJECTION - 1GM/200ML (5MG/ML), SOLUTION;INJECTION - 200MG/20ML (10MG/ML), SOLUTION;INJECTION - 200MG/100ML (2MG/ML), SOLUTION;INJECTION - 20MG/10ML (2MG/ML), SOLUTION;INJECTION - 400MG/200ML (2MG/ML), SOLUTION;INJECTION - 40MG/20ML (2MG/ML), SOLUTION;INJECTION - 500MG/100ML (5MG/ML), SOLUTION;INJECTION - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INJECTION - 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INJECTION - 100MG/10ML (10MG/ML)
SOLUTION;INJECTION - 100MG/20ML (5MG/ML)
SOLUTION;INJECTION - 150MG/30ML (5MG/ML)
SOLUTION;INJECTION - 150MG/20ML (7.5MG/ML)
SOLUTION;INJECTION - 1GM/200ML (5MG/ML)
SOLUTION;INJECTION - 200MG/20ML (10MG/ML)
SOLUTION;INJECTION - 200MG/100ML (2MG/ML)
SOLUTION;INJECTION - 20MG/10ML (2MG/ML)
SOLUTION;INJECTION - 400MG/200ML (2MG/ML)
SOLUTION;INJECTION - 40MG/20ML (2MG/ML)
SOLUTION;INJECTION - 500MG/100ML (5MG/ML)
SOLUTION;INJECTION - 50MG/10ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INJECTION - 75MG/10ML (7.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Actylis

3 Actylis

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 28 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
28 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 25 Finished Drug Prices

1 US Medicaid Prescriptions
25 Finished Drug Prices

MARKET PLACE

17 APIs, 2 FDF Dossiers

17 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 US Patents, 14 Health Canada Patents

6 US Patents
14 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 3 USP, 15 Others

3 EDQM
3 USP
15 Others

$ API Ref.Price (USD/KG) : 1,355 Xls

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11 All

01 1Adcock Ingram Limited

02 6Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

03 4Fresenius Kabi South Africa (Pty) Ltd

filter Active Ingredients Reset all filters

11 All

01 1Ropivacaine

02 6Ropivacaine Hydrochloride

03 4Ropivacaine hydrochloride

filter Dosage Form Reset all filters

11 All

01 5INF

02 6INJ

filter Brand Name Reset all filters

11 All

01 1Adco Ropivacaine 200mg/100ml

02 1Naropin 10Ml Polyampoule

03 1Naropin 10mg/ml Polyamp

04 1Naropin 20Mg/Ml Polyamp

05 2Naropin 2mg/ml Polybag

06 1Naropin 7.5mg/ml Polyamp

07 1ROPIVACAINE 10mg/ml INJECTION FRESENIUS

08 2ROPIVACAINE 2mg/ml INFUSION FRESENIUS

09 1ROPIVACAINE 7.5mg/ml INJECTION FRESENIUS

Chemwerth Ropivacaine HCl

List of Suppliers

Product Main Page

01

Adcock Ingram Limited

2024 ACI Convention

Not Confirmed

Adcock Ingram Limited

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ropivacaine Hydrochloride

Brand Name : Adco Ropivacaine 200mg/100ml

Dosage Form : INF

Dosage Strength : 200mg/100ml

Packaging : 100X5mg/100ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ropivacaine

Brand Name : Naropin 10Ml Polyampoule

Dosage Form : INJ

Dosage Strength : 5mg/ml

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Ropivacaine Hydrochloride

Brand Name : Naropin 20Mg/Ml Polyamp

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 20X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ropivacaine Hydrochloride

Brand Name : Naropin 7.5mg/ml Polyamp

Dosage Form : INJ

Dosage Strength : 2mg/ml

Packaging : 10X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ropivacaine Hydrochloride

Brand Name : Naropin 10mg/ml Polyamp

Dosage Form : INJ

Dosage Strength : 10mg/ml

Packaging : 10X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ropivacaine Hydrochloride

Brand Name : Naropin 2mg/ml Polybag

Dosage Form : INF

Dosage Strength : 2mg/ml

Packaging : 100X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ropivacaine Hydrochloride

Brand Name : Naropin 2mg/ml Polybag

Dosage Form : INF

Dosage Strength : 2mg/ml

Packaging : 200X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Fresenius Kabi South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ropivacaine hydrochloride

Brand Name : ROPIVACAINE 2mg/ml INFUSION FRESENIUS

Dosage Form : INF

Dosage Strength : 2mg/ml

Packaging : 100X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Fresenius Kabi South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ropivacaine hydrochloride

Brand Name : ROPIVACAINE 2mg/ml INFUSION FRESENIUS

Dosage Form : INF

Dosage Strength : 2mg/ml

Packaging : 100X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Fresenius Kabi South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

2024 ACI Convention

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ropivacaine hydrochloride

Brand Name : ROPIVACAINE 7.5mg/ml INJECTION FRESENIUS

Dosage Form : INJ

Dosage Strength : 7.5mg/ml

Packaging : 10X5mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

Digital Content

Corporate PDF

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