IMIPENEM; CILASTATIN | Marketing Authorisations | MA | Europe | PharmaCompass.com

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IMIPENEM; CILASTATIN
Europe

Evonik

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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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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With Fermion, start the journey of your innovative API.

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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

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Temad- We think of world-class quality.

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IMIPENEM; CILASTATIN

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

20 API Suppliers, 5 USDMF, 2 CEP/COS, 1 JDMF, 3 EU WC, 5 KDMF, 2 NDC API, 8 Listed Suppliers, $ API Reference Price

20 API Suppliers
5 USDMF
2 CEP/COS
1 JDMF
3 EU WC
5 KDMF
2 NDC API
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

35 FDF Dossiers, 13 FDA Orange Book, 19 Europe, 3 Listed Dossiers

35 FDF Dossiers
13 FDA Orange Book
19 Europe
3 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- EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL;500MG/VIAL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- EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Kirsch Pharma

1 SPI Pharma
1 Kirsch Pharma

EXCIPIENTS BY APPLICATIONS

1 Parenteral, 1 API Stability Enhancers

1 Parenteral
1 API Stability Enhancers

GLOBAL SALES INFORMATION

7 US Medicaid Prescriptions

7 US Medicaid Prescriptions

MARKET PLACE

6 APIs

6 APIs

PATENTS & EXCLUSIVITIES

3 US Patents, 2 US Exclusivities

3 US Patents
2 US Exclusivities

REF. STANDARDS & IMPURITIES

3 EDQM

3 EDQM

$ API Ref.Price (USD/KG) : 1,070 Xls

Filters

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Filters

FILTER :

filter Applicant Reset all filters

19 All

01 1Actavis Group Ptc Ehf.

02 1Campus Pharma Ab

03 2Elc Group Sro

04 1Fresenius Kabi Ab

05 2Fresenius Kabi Espa?a, Sau

06 1Medartuum Ab

07 1Medreg Sro

08 2Merck Sharp & Dohme Bv

09 1Orifarm Ab

10 1Pfizer Ab

11 1Ranbaxy (Uk) Ltd

12 2Sandoz A/S

13 1Steriscience Bv

14 1Stravencon Limited

15 1Teva Sweden Ab

filter Active Ingredients Reset all filters

19 All

01 14Cilastatin Sodium; Imipenem Monohydrate

02 1Cilastatin Sodium; Imipenem Monohydrate; Relebactam Monohydrate

03 4Imipenem; Cilastatin Sodium

filter Dosage Form Reset all filters

19 All

01 4Powder For Solution For Infusion

02 15Solution For Injection

filter Country Reset all filters

19 All

01 4Spain

02 15Sweden

filter Brand Name Reset all filters

19 All

01 1Campenam

02 1Imicilast

03 1Imipenem/Cilastatin Actavis

04 2Imipenem/Cilastatin Elc

05 1Imipenem/Cilastatin Fresenius Kabi

06 2Imipenem/Cilastatin Kabi

07 1Imipenem/Cilastatin Orifarm

08 1Imipenem/Cilastatin Pfizer

09 1Imipenem/Cilastatin Ranbaxy

10 2Imipenem/Cilastatin Sandoz

11 1Imipenem/Cilastatin Steriscience

12 1Imipenem/Cilastatin Stravencon

13 1Imipenem/Cilastatin Teva

14 1Recarbrio

15 2Tienam

List of Suppliers

Product Main Page

01

Fresenius Kabi Ab

FNCE

Not Confirmed

Fresenius Kabi Ab

FNCE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Fresenius Kabi

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 09/10/2009

Application Number : 20071211000015

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Actavis Group Ptc Ehf.

FNCE

Not Confirmed

Actavis Group Ptc Ehf.

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Actavis

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 08/10/2010

Application Number : 20080610000069

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Medartuum Ab

FNCE

Not Confirmed

Medartuum Ab

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Tienam

Dosage Form : Solution For Injection

Dosage Strength :

Packaging :

Approval Date : 02/11/2001

Application Number : 20011102000052

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Orifarm Ab

FNCE

Not Confirmed

Orifarm Ab

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Orifarm

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 12/03/2024

Application Number : 20231109000071

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Pfizer Ab

FNCE

Not Confirmed

Pfizer Ab

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Pfizer

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 10/09/2010

Application Number : 20090505000029

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Ranbaxy (Uk) Ltd

FNCE

Not Confirmed

Ranbaxy (Uk) Ltd

FNCE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Ranbaxy

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 23/10/2009

Application Number : 20071206000044

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Sandoz A/S

FNCE

Not Confirmed

Sandoz A/S

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Sandoz

Dosage Form : Solution For Injection

Dosage Strength : 250mg;250mg

Packaging :

Approval Date : 14/06/2012

Application Number : 20100508000152

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Sandoz A/S

FNCE

Not Confirmed

Sandoz A/S

FNCE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Sandoz

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 14/06/2012

Application Number : 20100508000183

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Steriscience Bv

FNCE

Not Confirmed

Steriscience Bv

FNCE

Not Confirmed

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Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Steriscience

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 14/12/2023

Application Number : 20211206000037

Regulatory Info : Approved

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Stravencon Limited

FNCE

Not Confirmed

Stravencon Limited

FNCE

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Cilastatin Sodium; Imipenem Monohydrate

Brand Name : Imipenem/Cilastatin Stravencon

Dosage Form : Solution For Injection

Dosage Strength : 500mg;500mg

Packaging :

Approval Date : 27/05/2015

Application Number : 20131211000030

Regulatory Info : Deregistered

Registration Country : Sweden

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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