Imipenem Anhydrous | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Imipenem Anhydrous
South Africa

Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Kewpie is your partner for Sodium Hyaluronate & Hyaluronic Acid// CEP, USDMF, KDMF & JDMF registered.

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xyz-pharma-m-2025-03-24

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Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.

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AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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xyz-pharma-m-2025-03-17

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Imipenem Anhydrous

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ACTIVE PHARMA INGREDIENTS

27 API Suppliers, 13 USDMF, 3 CEP/COS, 2 JDMF, 1 EU WC, 3 KDMF, 3 NDC API, 10 Listed Suppliers, $ API Reference Price

27 API Suppliers
13 USDMF
3 CEP/COS
2 JDMF
1 EU WC
3 KDMF
3 NDC API
10 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers, 13 FDA Orange Book, 10 Europe, 4 Canada, 9 South Africa, 12 Listed Dossiers

48 FDF Dossiers
13 FDA Orange Book
10 Europe
4 Canada
9 South Africa
12 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

POWDER;INTRAVENOUS - EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL;500MG/VIAL

POWDER;INTRAVENOUS - EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL;500MG/VIAL

RELATED EXCIPIENT COMPANIES

1 SPI Pharma

1 SPI Pharma

DIGITAL CONTENT

20 News #PharmaBuzz

20 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 10 Regulatory FDF Prices, 10 Annual Reports

1 US Medicaid Prescriptions
10 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

16 APIs, 4 FDF Dossiers

16 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

3 US Patents, 2 US Exclusivities

3 US Patents
2 US Exclusivities

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 Others

1 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 1,418 Xls

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9 All

01 1Abex Pharmaceutica (Pty) Ltd

02 1Austell Laboratories (Pty) Ltd

03 2Fresenius Kabi South Africa (Pty) Ltd

04 1MSD (Pty) Ltd

05 1Macleods Pharmaceuticals SA (Pty) Ltd

06 1Pharma Dynamics (Pty) Ltd

07 1Ranbaxy Pharmaceuticals (Pty) Ltd

08 1Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

9 All

01 3IMIPENEM

02 6Imipenem

filter Dosage Form Reset all filters

9 All

01 4INF

02 5INJ

filter Brand Name Reset all filters

9 All

01 1ACTAPEN 500

02 1CILNEM

03 1Cilapen 500

04 2IMIPENEM/CILASTATIN 500MG/500MG FRESENIUS

05 1Imcil 500mg**

06 1Sepencil 500 mg

07 1TIASEP

08 1Tienam 500

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01

Abex Pharmaceutica (Pty) Ltd

Peptide Therapy Summit

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Abex Pharmaceutica (Pty) Ltd

Peptide Therapy Summit

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : CILNEM

Dosage Form : INJ

Dosage Strength : 500mg

Packaging : 100X10mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Austell Laboratories (Pty) Ltd

Peptide Therapy Summit

Not Confirmed

Austell Laboratories (Pty) Ltd

Peptide Therapy Summit

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Imcil 500mg**

Dosage Form : INJ

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Fresenius Kabi South Africa (Pty) Ltd

Peptide Therapy Summit

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

Peptide Therapy Summit

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : IMIPENEM/CILASTATIN 500MG/500MG FRESENIUS

Dosage Form : INF

Dosage Strength : 500mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Fresenius Kabi South Africa (Pty) Ltd

Peptide Therapy Summit

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

Peptide Therapy Summit

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : IMIPENEM/CILASTATIN 500MG/500MG FRESENIUS

Dosage Form : INF

Dosage Strength : 500mg

Packaging : 20X10mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Macleods Pharmaceuticals SA (Pty) Ltd

Peptide Therapy Summit

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Macleods Pharmaceuticals SA (Pty) Ltd

Peptide Therapy Summit

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : TIASEP

Dosage Form : INJ

Dosage Strength : 500mg

Packaging : 100X10mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

Digital Content

06

MSD (Pty) Ltd

Peptide Therapy Summit

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MSD (Pty) Ltd

Peptide Therapy Summit

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Tienam 500

Dosage Form : INJ

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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07

Pharma Dynamics (Pty) Ltd

Peptide Therapy Summit

Not Confirmed

Pharma Dynamics (Pty) Ltd

Peptide Therapy Summit

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Sepencil 500 mg

Dosage Form : INF

Dosage Strength : 500mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Ranbaxy Pharmaceuticals (Pty) Ltd

Peptide Therapy Summit

Not Confirmed

Ranbaxy Pharmaceuticals (Pty) Ltd

Peptide Therapy Summit

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Cilapen 500

Dosage Form : INJ

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Teva Pharmaceuticals (Pty) Ltd

Peptide Therapy Summit

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

Peptide Therapy Summit

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : ACTAPEN 500

Dosage Form : INF

Dosage Strength : 500MG

Packaging : 100X10MG

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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