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Synopsis

ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: Tak-599, Schembl1464044, Gtpl10899, Q409712, (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 Formula
C22H21N8O8PS4
Molecular Weight
684.7  g/mol
InChI Key
ZCCUWMICIWSJIX-XHNDKCDBSA-N

Ceftaroline Fosamil
1 2D Structure

Ceftaroline Fosamil

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(6R,7R)-7-[[(2E)-2-ethoxyimino-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetyl]amino]-3-[[4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate
2.1.2 InChI
InChI=1S/C22H21N8O8PS4/c1-3-38-26-13(16-25-21(43-28-16)27-39(35,36)37)17(31)24-14-18(32)30-15(20(33)34)12(9-40-19(14)30)42-22-23-11(8-41-22)10-4-6-29(2)7-5-10/h4-8,14,19H,3,9H2,1-2H3,(H4-,24,25,27,28,31,33,34,35,36,37)/b26-13+/t14-,19-/m1/s1
2.1.3 InChI Key
ZCCUWMICIWSJIX-XHNDKCDBSA-N
2.1.4 Canonical SMILES
CCON=C(C1=NSC(=N1)NP(=O)(O)O)C(=O)NC2C3N(C2=O)C(=C(CS3)SC4=NC(=CS4)C5=CC=[N+](C=C5)C)C(=O)[O-]
2.1.5 Isomeric SMILES
CCO/N=C(\C1=NSC(=N1)NP(=O)(O)O)/C(=O)N[C@H]2[C@@H]3N(C2=O)C(=C(CS3)SC4=NC(=CS4)C5=CC=[N+](C=C5)C)C(=O)[O-]
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Ceftaroline Fosamil

2. Ppi-0903

3. Ppi0903

4. Tak-599

5. Tak599

6. Teflaro

2.2.2 Depositor-Supplied Synonyms

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

2.3 Create Date
2014-04-11
3 Chemical and Physical Properties
Molecular Weight 684.7 g/mol
Molecular Formula C22H21N8O8PS4
XLogP32.3
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count17
Rotatable Bond Count10
Exact Mass684.01028135 g/mol
Monoisotopic Mass684.01028135 g/mol
Topological Polar Surface Area330 Ų
Heavy Atom Count43
Formal Charge0
Complexity1210
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

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


4.2 ATC Code

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


API SUPPLIERS

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USDMF

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01

Acs Dobfar Spa

Italy

USDMF

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AACR Annual meeting
Not Confirmed

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 23167

Submission : 2009-10-09

Status : Active

Type : II

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AACR Annual meeting
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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

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AACR Annual meeting
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 40900

Submission : 2024-11-29

Status : Active

Type : II

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Listed Suppliers

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Ceftaroline Fosamil

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...

Akums Lifescience Ltd. is a research-based, vertically integrated company specializing in the development, manufacturing and sale of APIs and intermediates. Akums has established itself as a leading generic medicine manufacturing company from India, with clients in over 51 countries. It has a facility dedicated to custom research and synthesis. Akums’ manufacturing facilities are spread across three locations in two Indian states. Its stringent policies and procedures ensure that that all regulatory requirements, environmental standards, and technological trends are met. Akums is EU-GMP, KFDA, WHO-GMP and PMDA certified.
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Gencor

U.S.A
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Gencor

U.S.A
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Ceftaroline Fosamil

About the Company : Our herbal ingredients have been clinically studied and shown effective in both animal and human clinical trials. Many of our clinical trials are peer-reviewed, double-blind contro...

Our herbal ingredients have been clinically studied and shown effective in both animal and human clinical trials. Many of our clinical trials are peer-reviewed, double-blind controlled trials with impressive results. In addition to formal research tests, our ingredients go through rigorous scientific analysis with our state-of-the-art testing equipment under GLP-certified conditions. Gencor botanicals are grown under the close supervision of our technical team and according to strict quality-assurance processes. For instance, our herbs are always dried in the shade, so they maintain their phytochemical content.
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Ceftaroline Fosamil

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...

Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include customized R&D as well as the production of small molecule pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) for both international and domestic pharmaceutical firms. Our capabilities span from laboratory-scale kilograms to commercial ton-scale production. Additionally, we are committed to independent research and development, as well as the production and sales of high-end pharmaceutical intermediates and API products.
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Ceftaroline Fosamil

About the Company : Suzhou Ryway Biotech Co., Ltd. is located in Suzhou of Jiangsu Provice. It is a comprehensive enterprise integrated of product research, manufacturing, marketing and service. There...

Suzhou Ryway Biotech Co., Ltd. is located in Suzhou of Jiangsu Provice. It is a comprehensive enterprise integrated of product research, manufacturing, marketing and service. There is strong technical strength, advanced testing method, precision manufacturing equipment. Main products are medical intermediate and fine chemicals. The product is popular among domestic users. In addition, they have been exported to Southeast Asia, Europe and America regions. Our operation tenet is “quality first, customer first”. We constantly improve our market competitiveness. We expect to cooperate with wide colleagues and create brilliance together.
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FDA Orange Book

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ABBVIE

U.S.A

CEFTAROLINE FOSAMIL

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

Abbvie Company Banner

02

ABBVIE

U.S.A

CEFTAROLINE FOSAMIL

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

Abbvie Company Banner

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APOTEX

Canada
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APOTEX

Canada
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CEFTAROLINE FOSAMIL

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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APOTEX

Canada
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APOTEX

Canada
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CEFTAROLINE FOSAMIL

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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Europe

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ASTRAZENECA AB

United Kingdom
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ASTRAZENECA AB

United Kingdom
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Ceftaroline Fosamil

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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Pfizer Ag

U.S.A
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Pfizer Ag

U.S.A
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Ceftaroline Fosamil

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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ceftaroline fosamil

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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Ceftaroline Fosamyl

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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Ceftaroline Fosamil

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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Ceftaroline Fosamil

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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South Africa

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Ceftaroline fosamil

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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API | Excipient name

Ceftaroline Fosamil

Synonyms

Tak-599, Schembl1464044, Gtpl10899, Q409712, (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

TEFLARO Manufacturers

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.

TEFLARO Suppliers

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.

TEFLARO USDMF

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 GMP

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.

TEFLARO CoA

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).

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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