Ibandronate Sodium | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Ibandronate Sodium
South Africa

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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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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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Ibandronate Sodium

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

35 API Suppliers, 14 USDMF, 3 CEP/COS, 1 JDMF, 7 EU WC, 24 KDMF, 5 NDC API, 20 Listed Suppliers, $ API Reference Price

35 API Suppliers
14 USDMF
3 CEP/COS
1 JDMF
7 EU WC
24 KDMF
5 NDC API
20 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

2 Intermediates Suppliers

2 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

201 FDF Dossiers, 21 FDA Orange Book, 134 Europe, 1 Australia, 10 South Africa, 35 Listed Dossiers

201 FDF Dossiers
21 FDA Orange Book
134 Europe
1 Australia
10 South Africa
35 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 4 SPI Pharma, 2 Seqens, 4 DKSH, 4 Faran Shimi Pharmaceutical, 1 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 22 BASF, 1 Clariant, 10 Corel Pharma Chem, 5 DFE Pharma, 2 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 19 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

58 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 31 Controlled & Modified Release, 27 Direct Compression, 23 Lubricants & Glidants, 21 Thickeners and Stabilizers, 20 Film Formers & Plasticizers, 20 Disintegrants & Superdisintegrants, 19 Granulation, 14 Topical, 13 Solubilizers, 13 Co-Processed Excipients, 12 Parenteral, 8 Taste Masking, 7 Chewable & Orodispersible Aids, 5 Coloring Agents, 5 Emulsifying Agents, 5 Empty Capsules, 5 API Stability Enhancers, 4 Rheology Modifiers, 4 Vegetarian Capsules, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

58 Fillers, Diluents & Binders
55 Coating Systems & Additives
31 Controlled & Modified Release
27 Direct Compression
23 Lubricants & Glidants
21 Thickeners and Stabilizers
20 Film Formers & Plasticizers
20 Disintegrants & Superdisintegrants
19 Granulation
14 Topical
13 Solubilizers
13 Co-Processed Excipients
12 Parenteral
8 Taste Masking
7 Chewable & Orodispersible Aids
5 Coloring Agents
5 Emulsifying Agents
5 Empty Capsules
5 API Stability Enhancers
4 Rheology Modifiers
4 Vegetarian Capsules
1 Soft Gelatin
1 Surfactant & Foaming Agents

DIGITAL CONTENT

6 NEWS #PharmaBuzz

6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

112 Finished Drug Prices

112 Finished Drug Prices

MARKET PLACE

6 APIs, 3 FDF Dossiers

6 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 Health Canada Patents

2 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 2 Others

2 USP
2 Others

$ API Ref.Price (USD/KG) : 915 Xls

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10 All

01 2Pharmacare Limited, Woodmead

02 2Accord Healthcare (Pty) Ltd

03 5Adcock Ingram Limited

04 1Roche Products (Pty) Ltd

filter Active Ingredients Reset all filters

10 All

01 1Ibandronate Monosodium

02 9Ibandronic Acid

filter Dosage Form Reset all filters

10 All

01 7INJ

02 1PFS

03 2TAB

filter Brand Name Reset all filters

10 All

01 1Aspen Ibandronate 2mg IV

02 1Aspen Ibandronate 6mg IV

03 1BONRIX 2 mg/2 ml

04 1BONRIX 6 mg/6 ml

05 1Bondronat 1Ml

06 1Bondronat 2mg/2ml

07 1Bondronat 50

08 1Bondronat 6mg/6ml

09 1Boniva 150 mg

10 1Boniva 3mg/3ml

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ibandronic Acid

Brand Name : Aspen Ibandronate 2mg IV

Dosage Form : INJ

Dosage Strength : 2mg/2ml

Packaging : 2X1mg/2ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

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02

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ibandronic Acid

Brand Name : Aspen Ibandronate 6mg IV

Dosage Form : INJ

Dosage Strength : 6mg/6ml

Packaging : 6X1mg/6ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

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03

Accord Healthcare (Pty) Ltd

Pharma, Lab & Chemical Expo

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Accord Healthcare (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ibandronic Acid

Brand Name : BONRIX 2 mg/2 ml

Dosage Form : INJ

Dosage Strength : 2mg/2 ml

Packaging : 2X1mg/2 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

04

Accord Healthcare (Pty) Ltd

Pharma, Lab & Chemical Expo

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Accord Healthcare (Pty) Ltd

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Ibandronic Acid

Brand Name : BONRIX 6 mg/6 ml

Dosage Form : INJ

Dosage Strength : 6mg/6 ml

Packaging : 6X1mg/6 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

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05

Adcock Ingram Limited

Pharma, Lab & Chemical Expo

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Adcock Ingram Limited

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ibandronate Monosodium

Brand Name : Boniva 3mg/3ml

Dosage Form : PFS

Dosage Strength : 1mg/ml

Packaging : 3X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Product Web Link

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06

Adcock Ingram Limited

Pharma, Lab & Chemical Expo

Not Confirmed

Adcock Ingram Limited

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ibandronic Acid

Brand Name : Boniva 150 mg

Dosage Form : TAB

Dosage Strength : 150mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

07

Adcock Ingram Limited

Pharma, Lab & Chemical Expo

Not Confirmed

Adcock Ingram Limited

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ibandronic Acid

Brand Name : Bondronat 50

Dosage Form : TAB

Dosage Strength : 50mg

Packaging : 28X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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08

Adcock Ingram Limited

Pharma, Lab & Chemical Expo

Not Confirmed

Adcock Ingram Limited

Pharma, Lab & Chemical Expo

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ibandronic Acid

Brand Name : Bondronat 6mg/6ml

Dosage Form : INJ

Dosage Strength : 6mg/6ml

Packaging : 6X1mg/6ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Adcock Ingram Limited

Pharma, Lab & Chemical Expo

Not Confirmed

Adcock Ingram Limited

Pharma, Lab & Chemical Expo

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ibandronic Acid

Brand Name : Bondronat 2mg/2ml

Dosage Form : INJ

Dosage Strength : 2mg/2ml

Packaging : 2X1mg/2ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Roche Products (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Roche Products (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Ibandronic Acid

Brand Name : Bondronat 1Ml

Dosage Form : INJ

Dosage Strength : 18miu

Packaging : 21X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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