Synopsis
Synopsis
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USDMF
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EU WC
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EDQM
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USP
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JP
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Australia
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1. Ceftolozane
2. Cxa-101
3. Fr 264205
4. Fr-264205
5. Fr26 4205
6. Fr264205
1. 936111-69-2
2. Cxa-101
3. Ceftolozane Sulfate [usan]
4. 7r247u84hy
5. Fr264205
6. Fr-264205
7. Ceftolozane
8. (6r,7r)-3-[[3-amino-4-(2-aminoethylcarbamoylamino)-2-methylpyrazol-1-ium-1-yl]methyl]-7-[[(2z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid;hydrogen Sulfate
9. Cxa-101 (for Sulfate)
10. Unii-7r247u84hy
11. Cxa 101
12. Fr 264205
13. Ceftolozane Sulfate [mi]
14. Ceftolozane Sulfate (jan/usan)
15. Ceftolozane Sulfate [jan]
16. Cxa-301
17. Dtxsid001027693
18. Ceftolozane Sulfate [vandf]
19. Ex-a4483
20. Ceftolozane Sulfate [who-dd]
21. Ceftolozane Sulfate [orange Book]
22. Ac-36560
23. Zerbaxa Component Ceftolozane Sulfate
24. Ceftolozane Sulfate Component Of Zerbaxa
25. D10098
26. 1h-pyrazolium, 5-amino-4-((((2-aminoethyl)amino)carbonyl)amino)-2-(((6r,7r)-7-(((2z)- 2-(5-amino-1,2,4-thiadiazol-3-yl)-2-((1-carboxy-1-methylethoxy)imino)acetyl)amino)-2- Carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-1-methyl-, Sulfate (1:1)
27. 5-amino-4-(((2-aminoethyl)carbamoyl)amino)-2-(((6r,7r)-7-(((2z)-2-(5-amino-1,2,4- Thiadiazol-3-yl)-2-((1-carboxy-1-methylethoxy)imino)acetyl)amino)-2-carboxy-8-oxo-5- Thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-1-methyl-1h-pyrazolium Monosulfate
28. 5-amino-4-(((2-aminoethyl)carbamoyl)amino)-2-(((6r,7r)-7-(((2z)-2-(5-amino-1,2,4- Thiadiazol-3-yl)-2-((1-carboxy-1-methylethoxy)imino)acetyl)amino)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-1-methyl-1h-pyrazolium Monosulfate
Molecular Weight | 764.8 g/mol |
---|---|
Molecular Formula | C23H32N12O12S3 |
Hydrogen Bond Donor Count | 9 |
Hydrogen Bond Acceptor Count | 20 |
Rotatable Bond Count | 12 |
Exact Mass | 764.14247802 g/mol |
Monoisotopic Mass | 764.14247802 g/mol |
Topological Polar Surface Area | 439 Ų |
Heavy Atom Count | 50 |
Formal Charge | 0 |
Complexity | 1360 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
NDC Package Code : 52946-0923
Start Marketing Date : 2015-09-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2016-11-18
Registration Number : Su90-19-ND
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 1, 7/9 - 20871 Vimercate (MB), Italy
Registrant Name : Korea MSD Co., Ltd.
Registration Date : 2016-11-18
Registration Number : Su90-19-ND
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 1, 7/9 - 20871 Vimercate (MB), Italy
NDC Package Code : 52946-0923
Start Marketing Date : 2015-09-14
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...
About the Company : MolCore specialized in the developing, production and marketing of the raw material for medicine, pharmaceutical intermediates, and fine chemical products. Now our main business sc...
About the Company : Established in 1992 as an export-oriented unit (EOU), Orchid Pharma Ltd. (Orchid) is a vertically integrated company spanning the entire pharmaceutical value chain from discovery t...
Regulatory Info : RX
Registration Country : USA
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
Brand Name : ZERBAXA
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL
Packaging :
Approval Date : 2014-12-19
Application Number : 206829
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Several substances refer to content
Brand Name : Zerbaxa
Dosage Form : POWDER FOR CONCENTRATE FOR
Dosage Strength : 1 G / 0.5 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Ceftolozane Sulfate; Tazobactam
Brand Name : Zerbaxa
Dosage Form : Ceftolozano+Tazobactam 1G+0,5G 10 Units Parenteral Use
Dosage Strength : 10 bottles groun EV 1 g + 0 g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Zerbaxa
Dosage Form : Powder to concentrate to the infusion fluid, resolution
Dosage Strength : 1 g/0.5 g
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zerbaxa
Dosage Form : INF
Dosage Strength : 1000mg
Packaging : 20X10mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Prescription
Registration Country : Canada
CEFTOLOZANE (CEFTOLOZANE SULFATE)
Brand Name : ZERBAXA
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1G/VIAL
Packaging : 11.4ML (RECONST.) (1.5G)
Approval Date :
Application Number : 2446901
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Sweden
Several substances refer to content
Brand Name : Zerbaxa
Dosage Form : POWDER FOR CONCENTRATE FOR
Dosage Strength : 1 G / 0.5 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Ceftolozane Sulfate; Tazobactam
Brand Name : Zerbaxa
Dosage Form : Ceftolozano+Tazobactam 1G+0,5G 10 Units Parenteral Use
Dosage Strength : 10 bottles groun EV 1 g + 0 g
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Zerbaxa
Dosage Form : Powder to concentrate to the infusion fluid, resolution
Dosage Strength : 1 g/0.5 g
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zerbaxa
Dosage Form : INF
Dosage Strength : 1000mg
Packaging : 20X10mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Related Excipient Companies
Excipients by Applications
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
Patent Expiration Date : 2034-03-14
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US Patent Number : 10420841
Drug Substance Claim :
Drug Product Claim :
Application Number : 206829
Patent Use Code : U-1672
Delist Requested :
Patent Use Description : TREATMENT OF COMPLICAT...
Patent Expiration Date : 2034-03-14
Patent Expiration Date : 2034-03-14
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US Patent Number : 8968753
Drug Substance Claim :
Drug Product Claim :
Application Number : 206829
Patent Use Code : U-1673
Delist Requested :
Patent Use Description : TREATMENT OF COMPLICAT...
Patent Expiration Date : 2034-03-14
Patent Expiration Date : 2032-09-27
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US Patent Number : 8476425
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 206829
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2032-09-27
Patent Expiration Date : 2034-03-14
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US Patent Number : 10420841
Drug Substance Claim :
Drug Product Claim :
Application Number : 206829
Patent Use Code : U-3361
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-03-14
Patent Expiration Date : 2034-09-09
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US Patent Number : 10376496
Drug Substance Claim :
Drug Product Claim :
Application Number : 206829
Patent Use Code : U-2610
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-09-09
Patent Expiration Date : 2028-05-15
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US Patent Number : 7129232
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 206829
Patent Use Code : U-36
Delist Requested :
Patent Use Description : METHODS OF TREATING BA...
Patent Expiration Date : 2028-05-15
Patent Expiration Date : 2034-03-14
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US Patent Number : 9872906
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 206829
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-03-14
Patent Expiration Date : 2034-03-14
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US Patent Number : 10420841
Drug Substance Claim :
Drug Product Claim :
Application Number : 206829
Patent Use Code : U-3360
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-03-14
Patent Expiration Date : 2034-03-14
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US Patent Number : 10420841
Drug Substance Claim :
Drug Product Claim :
Application Number : 206829
Patent Use Code : U-2631
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-03-14
Patent Expiration Date : 2032-09-27
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
US Patent Number : 8685957
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 206829
Patent Use Code : U-36
Delist Requested :
Patent Use Description : METHODS OF TREATING BA...
Patent Expiration Date : 2032-09-27
ABOUT THIS PAGE
35
PharmaCompass offers a list of Ceftolozane Sulfate 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 Ceftolozane Sulfate manufacturer or Ceftolozane Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ceftolozane Sulfate manufacturer or Ceftolozane Sulfate supplier.
PharmaCompass also assists you with knowing the Ceftolozane Sulfate API Price utilized in the formulation of products. Ceftolozane Sulfate API Price is not always fixed or binding as the Ceftolozane Sulfate Price is obtained through a variety of data sources. The Ceftolozane Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ceftolozane Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ceftolozane Sulfate, including repackagers and relabelers. The FDA regulates Ceftolozane Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ceftolozane Sulfate 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 Ceftolozane Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ceftolozane Sulfate supplier is an individual or a company that provides Ceftolozane Sulfate active pharmaceutical ingredient (API) or Ceftolozane Sulfate finished formulations upon request. The Ceftolozane Sulfate suppliers may include Ceftolozane Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Ceftolozane Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Ceftolozane Sulfate Drug Master File in Korea (Ceftolozane Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ceftolozane Sulfate. The MFDS reviews the Ceftolozane Sulfate KDMF as part of the drug registration process and uses the information provided in the Ceftolozane Sulfate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ceftolozane Sulfate 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 Ceftolozane Sulfate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ceftolozane Sulfate 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 Ceftolozane Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ceftolozane Sulfate 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 Ceftolozane Sulfate 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 Ceftolozane Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ceftolozane Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ceftolozane Sulfate suppliers with NDC on PharmaCompass.
Ceftolozane Sulfate 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 Ceftolozane Sulfate 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 Ceftolozane Sulfate GMP manufacturer or Ceftolozane Sulfate GMP API supplier for your needs.
A Ceftolozane Sulfate CoA (Certificate of Analysis) is a formal document that attests to Ceftolozane Sulfate's compliance with Ceftolozane Sulfate specifications and serves as a tool for batch-level quality control.
Ceftolozane Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Ceftolozane Sulfate 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.
Ceftolozane Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ceftolozane Sulfate EP), Ceftolozane Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ceftolozane Sulfate USP).