Synopsis
Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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NDC API
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VMF
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EDQM
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USP
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JP
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Others
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Canada
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Australia
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers


1. Ceftaroline Fosamil
2. Ppi-0903
3. Ppi0903
4. Tak-599
5. Tak599
6. Teflaro
1. Tak-599
2. Schembl1464044
3. Gtpl10899
4. Q409712
5. (6r,7r)-7-((z)-2-(ethoxyimino)-2-(5-(phosphonoamino)-1,2,4-thiadiazol-3-yl)acetamido)-3-((4-(1-methylpyridin-1-ium-4-yl)thiazol-2-yl)thio)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
| Molecular Weight | 684.7 g/mol |
|---|---|
| Molecular Formula | C22H21N8O8PS4 |
| XLogP3 | 2.3 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 17 |
| Rotatable Bond Count | 10 |
| Exact Mass | 684.01028135 g/mol |
| Monoisotopic Mass | 684.01028135 g/mol |
| Topological Polar Surface Area | 330 Ų |
| Heavy Atom Count | 43 |
| Formal Charge | 0 |
| Complexity | 1210 |
| 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 | 1 |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J01DI02
S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23167
Submission : 2009-10-09
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-08-27
Pay. Date : 2014-05-16
DMF Number : 28245
Submission : 2014-06-25
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40900
Submission : 2024-11-29
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : Akums Lifescience Ltd. is a research-based, vertically integrated company specializing in the development, manufacturing and sale of APIs and intermediates. Akums has established i...

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RLD : Yes
TE Code : AP
Brand Name : TEFLARO
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 400MG/VIAL
Approval Date : 2010-10-29
Application Number : 200327
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
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RLD : Yes
TE Code : AP
Brand Name : TEFLARO
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 600MG/VIAL
Approval Date : 2010-10-29
Application Number : 200327
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AP
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RLD : No
TE Code : AP
Brand Name : CEFTAROLINE FOSAMIL
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 400MG/VIAL
Approval Date : 2021-09-21
Application Number : 208075
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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RLD : No
TE Code : AP
Brand Name : CEFTAROLINE FOSAMIL
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 600MG/VIAL
Approval Date : 2021-09-21
Application Number : 208075
RX/OTC/DISCN : RX
RLD : No
TE Code : AP

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Regulatory Info :
Registration Country : Italy
Brand Name : Zinforo
Dosage Form : Ceftarolina Fosamil 600Mg 1 Unit Parenteral Use
Dosage Strength : 10 VIALS EV 600 mg Groun
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Zinforo
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 600mg
Packaging :
Approval Date : 29/08/2013
Application Number : 62672
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Zinforo
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 600mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Zinforum
Dosage Form : Powder For Concentrate For Infusion Solution
Dosage Strength : 600MG
Packaging :
Approval Date : 25-10-2012
Application Number : 12785001
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Zinforo
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 600mg
Packaging :
Approval Date : 23-08-2012
Application Number : 28104865511
Regulatory Info : Prescription
Registration Country : Denmark

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Ceftaroline Fosamil Qilu
Dosage Form : Powder For Concentrate For Solution For Infusion
Dosage Strength : 600MG
Packaging :
Approval Date : 19-06-2025
Application Number : 90401
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Zinforo 600mg
Dosage Form : INJ
Dosage Strength : 600mg
Packaging : 20X10mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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PharmaCompass offers a list of Ceftaroline Fosamil API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ceftaroline Fosamil manufacturer or Ceftaroline Fosamil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ceftaroline Fosamil manufacturer or Ceftaroline Fosamil supplier.
A TEFLARO manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TEFLARO, including repackagers and relabelers. The FDA regulates TEFLARO manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TEFLARO 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 TEFLARO manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A TEFLARO supplier is an individual or a company that provides TEFLARO active pharmaceutical ingredient (API) or TEFLARO finished formulations upon request. The TEFLARO suppliers may include TEFLARO API manufacturers, exporters, distributors and traders.
click here to find a list of TEFLARO suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A TEFLARO DMF (Drug Master File) is a document detailing the whole manufacturing process of TEFLARO active pharmaceutical ingredient (API) in detail. Different forms of TEFLARO DMFs exist exist since differing nations have different regulations, such as TEFLARO USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TEFLARO DMF submitted to regulatory agencies in the US is known as a USDMF. TEFLARO USDMF includes data on TEFLARO's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TEFLARO USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TEFLARO suppliers with USDMF on PharmaCompass.
TEFLARO 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 TEFLARO GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right TEFLARO GMP manufacturer or TEFLARO GMP API supplier for your needs.
A TEFLARO CoA (Certificate of Analysis) is a formal document that attests to TEFLARO's compliance with TEFLARO specifications and serves as a tool for batch-level quality control.
TEFLARO CoA mostly includes findings from lab analyses of a specific batch. For each TEFLARO 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.
TEFLARO may be tested according to a variety of international standards, such as European Pharmacopoeia (TEFLARO EP), TEFLARO JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TEFLARO USP).