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Also known as: Ertapenem sodium, Ertapenem monosodium, Ertapenem sodium [usan], Ertapenem monosodium (90per cent), 153773-82-1, Mk 0826
Molecular Formula
C22H24N3NaO7S
Molecular Weight
497.5  g/mol
InChI Key
ZXNAQFZBWUNWJM-HRXMHBOMSA-M

Ertapenem
A carbapenem derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of Gram-positive and Gram-negative bacterial infections including intra-abdominal infections, acute gynecological infections, complicated urinary tract infections, skin infections, and respiratory tract infections. It is also used to prevent infection in colorectal surgery.
1 2D Structure

Ertapenem

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
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
2.1.2 InChI
InChI=1S/C22H25N3O7S.Na/c1-9-16-15(10(2)26)20(28)25(16)17(22(31)32)18(9)33-13-7-14(23-8-13)19(27)24-12-5-3-4-11(6-12)21(29)30;/h3-6,9-10,13-16,23,26H,7-8H2,1-2H3,(H,24,27)(H,29,30)(H,31,32);/q;+1/p-1/t9-,10-,13+,14+,15-,16-;/m1./s1
2.1.3 InChI Key
ZXNAQFZBWUNWJM-HRXMHBOMSA-M
2.1.4 Canonical SMILES
CC1C2C(C(=O)N2C(=C1SC3CC([NH2+]C3)C(=O)NC4=CC=CC(=C4)C(=O)[O-])C(=O)[O-])C(C)O.[Na+]
2.1.5 Isomeric SMILES
C[C@@H]1[C@@H]2[C@H](C(=O)N2C(=C1S[C@H]3C[C@H]([NH2+]C3)C(=O)NC4=CC=CC(=C4)C(=O)[O-])C(=O)[O-])[C@@H](C)O.[Na+]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Ertapenem

2. Ertapenem Sodium

3. Invanoz

2.2.2 Depositor-Supplied Synonyms

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

2.3 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 497.5 g/mol
Molecular Formula C22H24N3NaO7S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count8
Rotatable Bond Count5
Exact Mass497.12326557 g/mol
Monoisotopic Mass497.12326557 g/mol
Topological Polar Surface Area192 Ų
Heavy Atom Count34
Formal Charge0
Complexity882
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

* 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.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Penem Antibacterial [EPC]; Carbapenems [CS]
5.3 ATC Code

J01DH03


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INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"3.97","actualQuantity":"3.97","unit":"KGS","unitRateFc":"5100","totalValueFC":"20382.4","currency":"USD","unitRateINR":"427380","date":"30-Dec-2023","totalValueINR":"1696698.6","totalValueInUsd":"20382.4","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"9483532","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO-7-GIL, GWACHEON-SI, GYEONGGI-DO,SDNF KOREA,REPUBLIC OF","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703874600,"product":"ERTAPENEM SODIUM","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"5100","totalValueFC":"1283529","currency":"USD","unitRateINR":"427380","date":"30-Dec-2023","totalValueINR":"106845000","totalValueInUsd":"1283529","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"9483532","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO-7-GIL, GWACHEON-SI, GYEONGGI-DO,SDNF KOREA,REPUBLIC OF","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732041000,"product":"ERTAPENEM SODIUM IH","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"122.19","actualQuantity":"122.185","unit":"KGS","unitRateFc":"5100","totalValueFC":"629876.6","currency":"USD","unitRateINR":"435030","date":"20-Nov-2024","totalValueINR":"53154140.55","totalValueInUsd":"629876.6","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"6779858","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO 7-GIL, GWACHEON- SI, GYEONGGI-DO, 13840, REPUBLIC OF KOREA KR","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1734633000,"product":"ERTAPENEM SODIUM IH ERTAPENEM SODIUM IH","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"173.56","actualQuantity":"173.559","unit":"KGS","unitRateFc":"5100","totalValueFC":"895370.5","currency":"USD","unitRateINR":"438345","date":"20-Dec-2024","totalValueINR":"76078719.86","totalValueInUsd":"895370.5","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"7363553","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO 7-GIL, GWACHEON- SI, GYEONGGI-DO, 13840, REPUBLIC OF KOREA Korea, Republic of","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1735756200,"product":"ERTAPENEM SODIUM ERTAPENEM SODIUM","address":"PLOT No.30, GALAXY ,","city":"BENGALURU","supplier":"SHANDONG ANHONG PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"STERISCIENCE SPECIALTIES PRIVATE LTD","customerCountry":"INDIA","quantity":"29.00","actualQuantity":"29","unit":"KGS","unitRateFc":"5087.4","totalValueFC":"147055.8","currency":"USD","unitRateINR":"437258.8","date":"02-Jan-2025","totalValueINR":"12680506.15","totalValueInUsd":"147055.8","indian_port":"Bangalore Air","hs_no":"29420090","bill_no":"7580065","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO. 29 HUAYUAN STREET LINYI COUNTY, DEZHOU, SHANDONG, CHINA SDNF CN","customerAddress":"PLOT No.30, GALAXY ,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737570600,"product":"ERTAPENEM SODIUM IH ERTAPENEM SODIUM IH","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"148.72","actualQuantity":"148.722","unit":"KGS","unitRateFc":"4800","totalValueFC":"721074.7","currency":"USD","unitRateINR":"418080","date":"23-Jan-2025","totalValueINR":"62177693.76","totalValueInUsd":"721074.7","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"7954822","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO 7-GIL, GWACHEON- SI, GYEONGGI-DO, 13840, REPUBLIC OF KOREA","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740508200,"product":"ERTAPENEM SODIUM IH ERTAPENEM SODIUM IH","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"72.41","actualQuantity":"72.411","unit":"KGS","unitRateFc":"4800","totalValueFC":"350713.9","currency":"USD","unitRateINR":"421200","date":"26-Feb-2025","totalValueINR":"30499513.2","totalValueInUsd":"350713.9","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"8571520","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO 7-GIL, GWACHEON- SI, GYEONGGI-DO, 13840, REPUBLIC OF KOREA KR","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743100200,"product":"ERTAPENEM SODIUM IH ERTAPENEM SODIUM IH","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"135.72","actualQuantity":"135.722","unit":"KGS","unitRateFc":"4800","totalValueFC":"656598.2","currency":"USD","unitRateINR":"419040","date":"28-Mar-2025","totalValueINR":"56872946.88","totalValueInUsd":"656598.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"9163659","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO 7-GIL, GWACHEON- SI, GYEONGGI-DO, 13840, REPUBLIC OF KOREA KR","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745865000,"product":"ERTAPENEM SODIUM IH ERTAPENEM SODIUM IH","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"24.00","actualQuantity":"24","unit":"KGS","unitRateFc":"4800","totalValueFC":"116274.2","currency":"USD","unitRateINR":"414720","date":"29-Apr-2025","totalValueINR":"9953280","totalValueInUsd":"116274.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"9773450","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO 7-GIL, GWACHEON- SI, GYEONGGI-DO, 13840, REPUBLIC OF KOREA KR","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745865000,"product":"ERTAPENEM SODIUM IH ERTAPENEM SODIUM IH","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"49.51","actualQuantity":"49.511","unit":"KGS","unitRateFc":"4800","totalValueFC":"239868.9","currency":"USD","unitRateINR":"414720","date":"29-Apr-2025","totalValueINR":"20533201.92","totalValueInUsd":"239868.9","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"9773450","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO 7-GIL, GWACHEON- SI, GYEONGGI-DO, 13840, REPUBLIC OF KOREA KR","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748457000,"product":"ERTAPENEM SODIUM IH ERTAPENEM SODIUM IH","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"16.69","actualQuantity":"16.685","unit":"KGS","unitRateFc":"4800","totalValueFC":"81215.4","currency":"USD","unitRateINR":"414720","date":"29-May-2025","totalValueINR":"6919603.2","totalValueInUsd":"81215.4","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2362298","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO 7-GIL, GWACHEON- SI, GYEONGGI-DO, 13840, REPUBLIC OF KOREA KR","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748457000,"product":"ERTAPENEM SODIUM IH ERTAPENEM SODIUM IH","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"4800","totalValueFC":"146027.1","currency":"USD","unitRateINR":"414720","date":"29-May-2025","totalValueINR":"12441600","totalValueInUsd":"146027.1","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2362298","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO 7-GIL, GWACHEON- SI, GYEONGGI-DO, 13840, REPUBLIC OF KOREA KR","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1748457000,"product":"ERTAPENEM SODIUM IH ERTAPENEM SODIUM IH","address":"6-3-865\/1\/2, FLAT NO.201,","city":"HYDERABAD, ANDHRA PRADESH","supplier":"JW HOLDINGS CO LTD","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"GLAND PHARMA LTD","customerCountry":"INDIA","quantity":"73.10","actualQuantity":"73.1","unit":"KGS","unitRateFc":"4800","totalValueFC":"355819.3","currency":"USD","unitRateINR":"414720","date":"29-May-2025","totalValueINR":"30316032","totalValueInUsd":"355819.3","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"2362298","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"38, GWACHEON-DAERO 7-GIL, GWACHEON- SI, GYEONGGI-DO, 13840, REPUBLIC OF KOREA KR","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"}]
18-Feb-2022
29-May-2025
KGS
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Quantity (KGS) & Unit rate (USD/KGS) over time

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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

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...

Jinan Tantu Chemicals

02

Indo Livestock Expo
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Indo Livestock Expo
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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...

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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...

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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...

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05

Scimplify

India
Indo Livestock Expo
Not Confirmed
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Scimplify

India
Indo Livestock Expo
Not Confirmed
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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, ...

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FDA Orange Book

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01

Indo Livestock Expo
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ERTAPENEM SODIUM

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

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02

EUGIA PHARMA

India
Indo Livestock Expo
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EUGIA PHARMA

India
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Indo Livestock Expo
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ERTAPENEM SODIUM

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

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03

GLAND

India
Indo Livestock Expo
Not Confirmed
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GLAND

India
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Indo Livestock Expo
Not Confirmed

ERTAPENEM SODIUM

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

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Indo Livestock Expo
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Indo Livestock Expo
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ERTAPENEM SODIUM

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

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05

Indo Livestock Expo
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Indo Livestock Expo
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ERTAPENEM SODIUM

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

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06

Indo Livestock Expo
Not Confirmed
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Indo Livestock Expo
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ERTAPENEM SODIUM

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

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07

SUN PHARM

India
Indo Livestock Expo
Not Confirmed
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SUN PHARM

India
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ERTAPENEM SODIUM

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 :

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Europe

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ertapenemmononatrium

Brand Name : INVANZ

Dosage Form : POWDER FOR CONCENTRATE FOR

Dosage Strength : 1 G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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02

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Ertapenem

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

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03

MSD

U.S.A
Indo Livestock Expo
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MSD

U.S.A
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Ertapenem

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

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Ertapenemum

Brand Name : Invanz

Dosage Form : Trockensub

Dosage Strength : 1g

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Canada

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ERTAPENEM (ERTAPENEM SODIUM)

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

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Indo Livestock Expo
Not Confirmed
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Indo Livestock Expo
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ERTAPENEM (ERTAPENEM SODIUM)

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

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ERTAPENEM (ERTAPENEM SODIUM)

Brand Name : INVANZ

Dosage Form : POWDER FOR SOLUTION

Dosage Strength : 1G/VIAL

Packaging : 10

Approval Date :

Application Number : 2247437

Regulatory Info :

Registration Country : Canada

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JUNO PHARMACEUTICALS CORP.

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JUNO PHARMACEUTICALS CORP.

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ERTAPENEM (ERTAPENEM SODIUM)

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

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DR REDDY'S LABORATORIES LTD

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DR REDDY'S LABORATORIES LTD

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ERTAPENEM (ERTAPENEM SODIUM)

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

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EUGIA PHARMA INC.

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EUGIA PHARMA INC.

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ERTAPENEM (ERTAPENEM SODIUM)

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

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Ertapenem

Brand Name : Ertapenem Aspen

Dosage Form : INJ

Dosage Strength : 1g

Packaging : 10X10g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Ertapenem

Brand Name : ABEXEM

Dosage Form : POI

Dosage Strength : 1g

Packaging : 10X10g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Ertapenem

Brand Name : Nivazen 1g

Dosage Form : POI

Dosage Strength : 1g

Packaging : 10X1g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Ertapenem

Brand Name : Invanz

Dosage Form : INJ

Dosage Strength : 1g

Packaging : 10X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Ertapenem

Brand Name : MSD Ertapenem

Dosage Form : INJ

Dosage Strength : 1g

Packaging : 10X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Ertapenem

Brand Name : INVABEX

Dosage Form : POI

Dosage Strength : 1g

Packaging : 10X10g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Aurogen South Africa (Pty) Ltd

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Aurogen South Africa (Pty) Ltd

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Ertapenem

Brand Name : Iverzam

Dosage Form : POI

Dosage Strength : 1g

Packaging : 1X1g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Ertapenem

Brand Name : Ertapenem

Dosage Form : Sterile Vial

Dosage Strength : 1000MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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  • EDQM
  • WHO-GMP

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Packaging :

Regulatory Info :

Ertapenem

Dosage : Sterile Vial

Dosage Strength : 1000MG

Brand Name : Ertapenem

Approval Date :

Application Number :

Registration Country : India

Company Banner

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Ertapenem

Brand Name :

Dosage Form : Injection

Dosage Strength : 1GM/1Vial

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Ertapenem

Dosage : Injection

Dosage Strength : 1GM/1Vial

Brand Name :

Approval Date :

Application Number :

Registration Country : Italy

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Antibiotice SA

Romania
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Antibiotice SA

Romania
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ertapenem sodium

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

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Antibiotice SA

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Antibiotice SA

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ertapenem sodium

Dosage : powder for concentrate...

Dosage Strength : 1G

Brand Name : ERTAPENEM Atb®

Approval Date :

Application Number :

Registration Country : Romania

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Ertapenem Sodium

Brand Name :

Dosage Form : Injection

Dosage Strength : 1G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Ertapenem Sodium

Dosage : Injection

Dosage Strength : 1G

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Ertapenem Sodium

Brand Name :

Dosage Form : Injection

Dosage Strength : 10ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Ertapenem Sodium

Dosage : Injection

Dosage Strength : 10ML

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Ertapenem

Brand Name :

Dosage Form : Injection

Dosage Strength : 1000MG

Packaging : Vial

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Ertapenem

Dosage : Injection

Dosage Strength : 1000MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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ertapenem sodium

Brand Name :

Dosage Form : Vial

Dosage Strength : 1G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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ertapenem sodium

Dosage : Vial

Dosage Strength : 1G

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Ertapenem

Brand Name :

Dosage Form : Lyo.Inj

Dosage Strength : 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

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Ertapenem

Dosage : Lyo.Inj

Dosage Strength : 100MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Ertapenem

Brand Name :

Dosage Form : Injection

Dosage Strength : 1gm

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Ertapenem

Dosage : Injection

Dosage Strength : 1gm

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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Ertapenem

Brand Name :

Dosage Form : Injection

Dosage Strength : 1G

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Taiwan

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Ertapenem

Dosage : Injection

Dosage Strength : 1G

Brand Name :

Approval Date :

Application Number :

Registration Country : Taiwan

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Brand Name : Invanz

U.S.A
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Brand Name : Invanz

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Ertapenem

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

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Brand Name : Invanz

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Ertapenem

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 :

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U.S.A
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Brand Name : Invanz

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Ertapenem

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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A company that focuses on distribution of various finished formulations is looking for suppliers of various finished dosage formulations. The suppliers must support this enquiry with ACTD dossier and GMP. 1. Ertapenem (500 mg) Vials. The required quantity is 60,000 units in the first year, 85,000 units in the second year, and 95,000 units in the third year. 2. Ertapenem (1000 mg) Vials. The required quantity is 100,000 units in the first year, 120,000 units in the second year, and 135,000 units in the third year. 3. Doripenem (500 mg) Vial. The required quantity is 85,000 units in the first year, 90,000 units in the second year, and 100,000 units in the third year. 4. Ceftazidime Avibactam (2500 mg) Vial. The required quantity is 50,000 units in the first year, 65,000 units in the second year, and 85,000 units in the third year. 5. Aztreonam (1 g) Injection. The required quantity is 130,000 units in the first year, 160,000 units in the second year, and 240,000 units in the third year. 6. Aztreonam (2 g) Injection. The required quantity is 100,000 units in the first year, 125,000 units in the second year, and 145,000 units in the third year. 7. Ampicillin and sulbactam (1.5 g) Injection. The required quantity is 500,000 units/ annum. 8. Ampicillin and sulbactam (750 g) Injection. The required quantity is 400,000 units/ annum. 9. Piperacillin and Tazobactam (2.25 g) Injection. The required quantity is 300,000 units/ annum. 10. Piperacillin and Tazobactam (4.5 g) Injection. The required quantity is 250,000 units.
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Patents & EXCLUSIVITIES

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Health Canada Patents

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Ertapenem

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

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ABOUT THIS PAGE

Looking for 153773-82-1 / Ertapenem API manufacturers, exporters & distributors?

Ertapenem manufacturers, exporters & distributors 1

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.

API | Excipient name

Ertapenem

Synonyms

Ertapenem sodium, Ertapenem monosodium, Ertapenem sodium [usan], Ertapenem monosodium (90per cent), 153773-82-1, Mk 0826

Cas Number

153773-82-1

About Ertapenem

A carbapenem derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of Gram-positive and Gram-negative bacterial infections including intra-abdominal infections, acute gynecological infections, complicated urinary tract infections, skin infections, and respiratory tract infections. It is also used to prevent infection in colorectal surgery.

Ertapenem Manufacturers

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.

Ertapenem Suppliers

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.

Ertapenem USDMF

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.

Ertapenem KDMF

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.

Ertapenem NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ertapenem API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Ertapenem CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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