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1. Ertapenem
2. Ertapenem Sodium
3. Invanoz
1. Ertapenem Sodium
2. Ertapenem Monosodium
3. Ertapenem Sodium [usan]
4. Ertapenem Monosodium (90per Cent)
5. 153773-82-1
6. Mk 0826
7. Sodium;(4r,5s,6s)-3-[(3s,5s)-5-[(3-carboxylatophenyl)carbamoyl]pyrrolidin-1-ium-3-yl]sulfanyl-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
8. 2t90ke67l0
9. Mk 826
10. Unii-2t90ke67l0
11. L 749345
12. 1-azabicyclo(3.2.0)hept-2-ene-2-carboxylic Acid, 3-(((3s,5s)-5-(((3-carboxyphenyl)amino)carbonyl)-3-pyrrolidinyl)thio)-6-((1r)-1-hydroxyethyl)-4-methyl-7-oxo-, Monosodium Salt, (4r,5s,6s)-
13. 1-azabicyclo(3.2.0)hept-2-ene-2-carboxylic Acid, 3-((5-(((3-carboxyphenyl)amino)carbonyl)-3-pyrrolidinyl)thio)-6-((1r)-1-hydroxyethyl)-4-methyl-7-oxo-, Monosodium Salt, (4r-(3(3s*,5s*),4alpha,5beta,6beta(r*)))-
14. Sodium (4r,5s,6s)-3-({(3s,5s)-5-[(3-carboxylatophenyl)carbamoyl]pyrrolidinium-3-yl}sulfanyl)-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
15. Sodium (4r,5s,6s)-3-({(3s,5s)-5-[(m-carboxylatophenyl)carbamoyl]pyrrolidinium-3-yl}sulfanyl)-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
16. Sodium (4r,5s,6s)-3-({(3s,5s)-5-[(m-carboxyphenyl)carbamoyl]-3-pyrrolidinyl}thio)-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate
Molecular Weight | 497.5 g/mol |
---|---|
Molecular Formula | C22H24N3NaO7S |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 8 |
Rotatable Bond Count | 5 |
Exact Mass | 497.12326557 g/mol |
Monoisotopic Mass | 497.12326557 g/mol |
Topological Polar Surface Area | 192 Ų |
Heavy Atom Count | 34 |
Formal Charge | 0 |
Complexity | 882 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 6 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
* Treatment:
Treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required:
- intra-abdominal infections;
- community-acquired pneumonia;
- acute gynaecological infections;
- diabetic foot infections of the skin and soft tissue.
* Prevention:
Invanz is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J01DH03
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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CAS Number : 219909-83-8
End Use API : Ertapenem
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
3-[(2S,4S)-4-Mercaptopyrrolidine-2-carboxamido]ben...
CAS Number : 219909-83-8
End Use API : Ertapenem
About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...
3-[(2S,4S)-4-Mercaptopyrrolidine-2-carboxamido]ben...
CAS Number : 219909-83-8
End Use API : Ertapenem
About The Company : Beijing Lunarsun pharma is a professional manufacturer of API and intermediates. The factory is approved by US FDA. According to EU and US FDA's requirement, we...
4-Nitrobenzyl 2-diazoacetoacetate
CAS Number : 82551-63-1
End Use API : Ertapenem
About The Company : Nantong Chem-land Co., Ltd. is located in Nantong city, a developed port city which distance from Shanghai is only 1.5 hours by car. Established in 2006, we hav...
2,2-Dimethyl-1,3-Dioxane-4,6 Dione (Meldrum's Acid...
CAS Number : 2033-24-1
End Use API : Ertapenem
About The Company : Scimplify is a science-first company specializing in end-to-end development and manufacturing of specialty chemicals. We support the entire product life cycle, ...
RLD : No
TE Code : AP
Brand Name : ERTAPENEM SODIUM
Dosage Form : INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 2018-04-16
Application Number : 208790
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : ERTAPENEM SODIUM
Dosage Form : INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 2018-06-25
Application Number : 209133
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : ERTAPENEM SODIUM
Dosage Form : INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 2021-03-26
Application Number : 212040
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : Yes
TE Code : AP
Brand Name : INVANZ
Dosage Form : INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 2001-11-21
Application Number : 21337
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
RLD : No
TE Code : AP
Brand Name : ERTAPENEM SODIUM
Dosage Form : INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 2024-10-31
Application Number : 218067
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code : AP
Brand Name : ERTAPENEM SODIUM
Dosage Form : INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 2019-03-19
Application Number : 207647
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : ERTAPENEM SODIUM
Dosage Form : INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
Dosage Strength : EQ 1GM BASE/VIAL
Approval Date : 2023-05-02
Application Number : 209145
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Regulatory Info :
Registration Country : Sweden
Brand Name : INVANZ
Dosage Form : POWDER FOR CONCENTRATE FOR
Dosage Strength : 1 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Invanz
Dosage Form : Ertapenem 1.000Mg 20Ml 1 Units Parenteral Use
Dosage Strength : 1 vial EV 1 g 20 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Invanz
Dosage Form : Powder to concentrate to the infusion fluid, resolution
Dosage Strength : 1 g
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Switzerland
Brand Name : Invanz
Dosage Form : Trockensub
Dosage Strength : 1g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Canada
Brand Name : ERTAPENEM FOR INJECTION
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1G/VIAL
Packaging :
Approval Date :
Application Number : 2492148
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : ERTAPENEM FOR INJECTION
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1G/VIAL
Packaging :
Approval Date :
Application Number : 2496127
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : INVANZ
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1G/VIAL
Packaging : 10
Approval Date :
Application Number : 2247437
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : ERTAPENEM FOR INJECTION
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1G/VIAL
Packaging :
Approval Date :
Application Number : 2490773
Regulatory Info :
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Canada
Brand Name : ERTAPENEM FOR INJECTION
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1G/VIAL
Packaging :
Approval Date :
Application Number : 2511150
Regulatory Info :
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Canada
Brand Name : ERTAPENEM FOR INJECTION
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1G/VIAL
Packaging :
Approval Date :
Application Number : 2537176
Regulatory Info :
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Ertapenem Aspen
Dosage Form : INJ
Dosage Strength : 1g
Packaging : 10X10g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : ABEXEM
Dosage Form : POI
Dosage Strength : 1g
Packaging : 10X10g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Nivazen 1g
Dosage Form : POI
Dosage Strength : 1g
Packaging : 10X1g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Invanz
Dosage Form : INJ
Dosage Strength : 1g
Packaging : 10X1g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : MSD Ertapenem
Dosage Form : INJ
Dosage Strength : 1g
Packaging : 10X1g
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : INVABEX
Dosage Form : POI
Dosage Strength : 1g
Packaging : 10X10g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Iverzam
Dosage Form : POI
Dosage Strength : 1g
Packaging : 1X1g
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : India
Brand Name : Ertapenem
Dosage Form : Sterile Vial
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Sterile Vial
Dosage Strength : 1000MG
Brand Name : Ertapenem
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Italy
Brand Name :
Dosage Form : Injection
Dosage Strength : 1GM/1Vial
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 1GM/1Vial
Brand Name :
Approval Date :
Application Number :
Registration Country : Italy
Regulatory Info :
Registration Country : Romania
Brand Name : ERTAPENEM Atb®
Dosage Form : powder for concentrate...
Dosage Strength : 1G
Packaging : Box x 10 vials
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Romania
Packaging : Box x 10 vials
Regulatory Info :
Dosage : powder for concentrate...
Dosage Strength : 1G
Brand Name : ERTAPENEM Atb®
Approval Date :
Application Number :
Registration Country : Romania
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 1G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 1G
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 10ML
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 1000MG
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : Vial
Regulatory Info :
Dosage : Injection
Dosage Strength : 1000MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Vial
Dosage Strength : 1G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Vial
Dosage Strength : 1G
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Lyo.Inj
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Packaging :
Regulatory Info : Generic
Dosage : Lyo.Inj
Dosage Strength : 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 1gm
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 1gm
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : Taiwan
Brand Name :
Dosage Form : Injection
Dosage Strength : 1G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Taiwan
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 1G
Brand Name :
Approval Date :
Application Number :
Registration Country : Taiwan
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Global Sales Information
Dosage Form : Ertapenem 1.000Mg 20Ml 1 Units P...
Dosage Strength : 1 vial EV 1 g 20 ml
Price Per Pack (Euro) : 67.03
Published in :
Country : Italy
RX/OTC/DISCN : Class H
Dosage Form : Powder to concentrate to the inf...
Dosage Strength : 1 g
Price Per Pack (Euro) : 55.528
Published in :
Country : Norway
RX/OTC/DISCN :
Dosage Form : Trockensub
Dosage Strength : 1g
Price Per Pack (Euro) : 48.17
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2013-02-02
Date Granted : 2003-11-25
Brand Name : INVANZ
Patent Number : 2106370
Filing Date : 1993-02-02
Strength per Unit : 1 g
Dosage Form : Sterile Lyophilized Powder
Human Or VET : Human
Route of Administration : Intravenous, Intramuscular
Patent Expiration Date : 2013-02-02
Date Granted : 2003-11-25
ABOUT THIS PAGE
48
PharmaCompass offers a list of Ertapenem API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ertapenem manufacturer or Ertapenem supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ertapenem manufacturer or Ertapenem supplier.
PharmaCompass also assists you with knowing the Ertapenem API Price utilized in the formulation of products. Ertapenem API Price is not always fixed or binding as the Ertapenem Price is obtained through a variety of data sources. The Ertapenem Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ertapenem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ertapenem, including repackagers and relabelers. The FDA regulates Ertapenem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ertapenem API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ertapenem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ertapenem supplier is an individual or a company that provides Ertapenem active pharmaceutical ingredient (API) or Ertapenem finished formulations upon request. The Ertapenem suppliers may include Ertapenem API manufacturers, exporters, distributors and traders.
click here to find a list of Ertapenem suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ertapenem DMF (Drug Master File) is a document detailing the whole manufacturing process of Ertapenem active pharmaceutical ingredient (API) in detail. Different forms of Ertapenem DMFs exist exist since differing nations have different regulations, such as Ertapenem USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ertapenem DMF submitted to regulatory agencies in the US is known as a USDMF. Ertapenem USDMF includes data on Ertapenem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ertapenem USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ertapenem suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ertapenem Drug Master File in Korea (Ertapenem KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ertapenem. The MFDS reviews the Ertapenem KDMF as part of the drug registration process and uses the information provided in the Ertapenem KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ertapenem KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ertapenem API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ertapenem suppliers with KDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ertapenem as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ertapenem API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Ertapenem as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Ertapenem and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ertapenem NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ertapenem suppliers with NDC on PharmaCompass.
Ertapenem Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Ertapenem GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ertapenem GMP manufacturer or Ertapenem GMP API supplier for your needs.
A Ertapenem CoA (Certificate of Analysis) is a formal document that attests to Ertapenem's compliance with Ertapenem specifications and serves as a tool for batch-level quality control.
Ertapenem CoA mostly includes findings from lab analyses of a specific batch. For each Ertapenem CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Ertapenem may be tested according to a variety of international standards, such as European Pharmacopoeia (Ertapenem EP), Ertapenem JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ertapenem USP).