Risedronic Acid | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Risedronic Acid
South Africa

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Risedronic Acid

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

41 API Suppliers, 17 USDMF, 8 CEP/COS, 6 JDMF, 11 EU WC, 26 KDMF, 9 NDC API, 26 Listed Suppliers, $ API Reference Price

41 API Suppliers
17 USDMF
8 CEP/COS
6 JDMF
11 EU WC
26 KDMF
9 NDC API
26 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

230 FDF Dossiers, 38 FDA Orange Book, 143 Europe, 4 Canada, 23 Australia, 5 South Africa, 17 Listed Dossiers

230 FDF Dossiers
38 FDA Orange Book
143 Europe
4 Canada
23 Australia
5 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 150MG, TABLET;ORAL - 30MG, TABLET;ORAL - 35MG, TABLET;ORAL - 5MG, TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 35MG

TABLET;ORAL - 150MG
TABLET;ORAL - 30MG
TABLET;ORAL - 35MG
TABLET;ORAL - 5MG
TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, DELAYED RELEASE;ORAL - 35MG

DIGITAL CONTENT

10 NEWS #PharmaBuzz

10 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 121 Finished Drug Prices, 1 Annual Reports

1 US Medicaid Prescriptions
121 Finished Drug Prices
1 Annual Reports

MARKET PLACE

5 APIs

5 APIs

PATENTS & EXCLUSIVITIES

3 US Patents, 15 Health Canada Patents

3 US Patents
15 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 3 JP, 4 Others

3 EDQM
1 USP
3 JP
4 Others

$ API Ref.Price (USD/KG) : 1,046 Xls

Filters

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FILTER :

filter Applicant Reset all filters

5 All

01 1Biotech Laboratories (Pty) Ltd

02 1Macleods Pharmaceuticals SA (Pty) Ltd

03 1Pharma Dynamics (Pty) Ltd

04 2Watson Pharma No. 1 (Pty) Ltd

filter Active Ingredients Reset all filters

5 All

01 1Risedronate Sodium

02 3Risedronate sodium

03 1risedronate

filter Dosage Form Reset all filters

5 All

01 3FCT

02 2TAB

filter Brand Name Reset all filters

5 All

01 1ACTONEL ONCE-A-MONTH

02 1Actamax 35 mg

03 1Actonel Once-A-Week

04 1Bontelvia 35 mg

05 1Risedronate 35 Biotech

Synnat Risedronate Sodium

List of Suppliers

Product Main Page

01

Watson Pharma No. 1 (Pty) Ltd

Antibody Engineering

Not Confirmed

Watson Pharma No. 1 (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Risedronate sodium

Brand Name : Actonel Once-A-Week

Dosage Form : FCT

Dosage Strength : 35mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Watson Pharma No. 1 (Pty) Ltd

Antibody Engineering

Not Confirmed

Watson Pharma No. 1 (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Risedronate sodium

Brand Name : ACTONEL ONCE-A-MONTH

Dosage Form : FCT

Dosage Strength : 150mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Biotech Laboratories (Pty) Ltd

Antibody Engineering

Not Confirmed

Biotech Laboratories (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Risedronate sodium

Brand Name : Risedronate 35 Biotech

Dosage Form : FCT

Dosage Strength : 35MG

Packaging : 4X1MG

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Macleods Pharmaceuticals SA (Pty) Ltd

Antibody Engineering

Not Confirmed

Macleods Pharmaceuticals SA (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

risedronate

Brand Name : Bontelvia 35 mg

Dosage Form : TAB

Dosage Strength : 35mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

05

Pharma Dynamics (Pty) Ltd

Antibody Engineering

Not Confirmed

Pharma Dynamics (Pty) Ltd

Antibody Engineering

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Risedronate Sodium

Brand Name : Actamax 35 mg

Dosage Form : TAB

Dosage Strength : 35mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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