Find Cefiderocol sulfate tosylate manufacturers, exporters & distributors on PharmaCompass

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Chemistry

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Also known as: Gsk2696266d, S-649266d, Ttp8lbp45d, Cefiderocol sulfate tosylate [usan], Gsk-2696266d, 2135543-94-9
Molecular Formula
C118H138Cl3N21O47S11
Molecular Weight
3061.6  g/mol
InChI Key
QNMVZYPDWLKAJC-RXVBEKIDSA-N

Cefiderocol sulfate tosylate
1 2D Structure

Cefiderocol sulfate tosylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(6R,7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(2-carboxypropan-2-yloxyimino)acetyl]amino]-3-[[1-[2-[(2-chloro-3,4-dihydroxybenzoyl)amino]ethyl]pyrrolidin-1-ium-1-yl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid;4-methylbenzenesulfonate;4-methylbenzenesulfonic acid;sulfate;hydrate
2.1.2 InChI
InChI=1S/3C30H34ClN7O10S2.4C7H8O3S.H2O4S.H2O/c3*1-30(2,28(46)47)48-36-19(16-13-50-29(32)34-16)24(42)35-20-25(43)37-21(27(44)45)14(12-49-26(20)37)11-38(8-3-4-9-38)10-7-33-23(41)15-5-6-17(39)22(40)18(15)31;4*1-6-2-4-7(5-3-6)11(8,9)10;1-5(2,3)4;/h3*5-6,13,20,26H,3-4,7-12H2,1-2H3,(H7-,32,33,34,35,36,39,40,41,42,44,45,46,47);4*2-5H,1H3,(H,8,9,10);(H2,1,2,3,4);1H2/t3*20-,26-;;;;;;/m111....../s1
2.1.3 InChI Key
QNMVZYPDWLKAJC-RXVBEKIDSA-N
2.1.4 Canonical SMILES
CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)[O-].CC(C)(C(=O)O)ON=C(C1=CSC(=N1)N)C(=O)NC2C3N(C2=O)C(=C(CS3)C[N+]4(CCCC4)CCNC(=O)C5=C(C(=C(C=C5)O)O)Cl)C(=O)O.CC(C)(C(=O)O)ON=C(C1=CSC(=N1)N)C(=O)NC2C3N(C2=O)C(=C(CS3)C[N+]4(CCCC4)CCNC(=O)C5=C(C(=C(C=C5)O)O)Cl)C(=O)O.CC(C)(C(=O)O)ON=C(C1=CSC(=N1)N)C(=O)NC2C3N(C2=O)C(=C(CS3)C[N+]4(CCCC4)CCNC(=O)C5=C(C(=C(C=C5)O)O)Cl)C(=O)O.O.[O-]S(=O)(=O)[O-]
2.1.5 Isomeric SMILES
CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)O.CC1=CC=C(C=C1)S(=O)(=O)[O-].CC(O/N=C(\C(=O)N[C@@H]1C(=O)N2[C@@H]1SCC(=C2C(=O)O)C[N+]3(CCCC3)CCNC(=O)C4=C(C(=C(C=C4)O)O)Cl)/C5=CSC(=N5)N)(C(=O)O)C.CC(O/N=C(\C(=O)N[C@@H]1C(=O)N2[C@@H]1SCC(=C2C(=O)O)C[N+]3(CCCC3)CCNC(=O)C4=C(C(=C(C=C4)O)O)Cl)/C5=CSC(=N5)N)(C(=O)O)C.CC(O/N=C(\C(=O)N[C@@H]1C(=O)N2[C@@H]1SCC(=C2C(=O)O)C[N+]3(CCCC3)CCNC(=O)C4=C(C(=C(C=C4)O)O)Cl)/C5=CSC(=N5)N)(C(=O)O)C.O.[O-]S(=O)(=O)[O-]
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Gsk2696266d

2. S-649266d

3. Ttp8lbp45d

4. Cefiderocol Sulfate Tosylate [usan]

5. Gsk-2696266d

6. 2135543-94-9

7. Unii-ttp8lbp45d

8. Chembl4297211

9. 1-(((6r,7r)-7-((2z)-2-(2-amino-1,3-thiazol-4-yl)-2-(((2-carboxypropan-2-yl)oxy)imino)acetamido)-2-carboxy-8-oxo-5-thia-1-azabicyclo(4.2.0)oct-2-en-3-yl)methyl)-1-(2-(2-chloro-3,4-dihydroxybenzamido)ethyl)pyrrolidin-1-ium 4-methylbenzenesulfonate, 4-methylbenzenesulfonic Acid, Sulfate, Hydrate (3:1:1:3:?)

10. Pyrrolidinium, 1-(((6r,7r)-7-(((2z)-2-(2-amino-4-thiazolyl)-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-(2-((2-chloro-3,4- Dihydroxybenzoyl)amino)ethyl)-, 4-methylbenzenesulfonate Sulfate, 4-methylbenzenesulfonate, Hydrate (3:1:1:3:?)

2.3 Create Date
2017-12-10
3 Chemical and Physical Properties
Molecular Weight 3061.6 g/mol
Molecular Formula C118H138Cl3N21O47S11
Hydrogen Bond Donor Count25
Hydrogen Bond Acceptor Count62
Rotatable Bond Count42
Exact Mass3058.508091 g/mol
Monoisotopic Mass3057.504737 g/mol
Topological Polar Surface Area1270 Ų
Heavy Atom Count200
Formal Charge0
Complexity1910
Isotope Atom Count0
Defined Atom Stereocenter Count6
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count3
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count9
4 Pharmacology and Biochemistry
4.1 FDA Pharmacological Classification
4.1.1 Pharmacological Classes
Cephalosporins [CS]; Cephalosporin Antibacterial [EPC]

API SUPPLIERS

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Shionogi

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BIO Partnering at JPM
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Shionogi

Japan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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BIO Partnering at JPM
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USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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NDC API

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Biotech Showcase
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CEFIDEROCOL SULFATE TOSYLATE

NDC Package Code : 53044-005

Start Marketing Date : 2020-01-31

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Drugs in Development

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Details:

Fetroja (cefiderocol) is a siderophore cephalosporin antibiotic under evaluation for treating complicated urinary tract infections, hospital-acquired & ventilator-associated bacterial pneumonia.


Lead Product(s): Cefiderocol sulfate tosylate,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 22, 2024

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Shionogi

Japan
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BIO Partnering at JPM
Not Confirmed

Shionogi

Japan
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BIO Partnering at JPM
Not Confirmed

Details : Fetroja (cefiderocol) is a siderophore cephalosporin antibiotic under evaluation for treating complicated urinary tract infections, hospital-acquired & ventilator-associated bacterial pneumonia.

Product Name : Fetroja

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 22, 2024

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Details:

Cefiderocol Sulfate Tosylate has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens. Fetroja achieved clinical cure in 63% of patients with Acinetobacter baumannii infections and 63% of patients with Pseudomonas aeruginosa infections.


Lead Product(s): Cefiderocol sulfate tosylate,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 20, 2022

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02

Shionogi

Japan
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BIO Partnering at JPM
Not Confirmed

Shionogi

Japan
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BIO Partnering at JPM
Not Confirmed

Details : Cefiderocol Sulfate Tosylate has a novel mechanism for penetrating the outer cell membrane of Gram-negative pathogens. Fetroja achieved clinical cure in 63% of patients with Acinetobacter baumannii infections and 63% of patients with Pseudomonas aerugino...

Product Name : Fetroja

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 20, 2022

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Details:

The collaboration agreement includes provisions to work with ministries of health and other experts to strengthen hospital-based stewardship programmes that ensure appropriate use. These provisions are especially important to avoid fuelling resistance to Fetroja (cefiderocol).


Lead Product(s): Cefiderocol sulfate tosylate,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Clinton Health Access Initiative

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration June 15, 2022

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Shionogi

Japan
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BIO Partnering at JPM
Not Confirmed

Shionogi

Japan
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BIO Partnering at JPM
Not Confirmed

Details : The collaboration agreement includes provisions to work with ministries of health and other experts to strengthen hospital-based stewardship programmes that ensure appropriate use. These provisions are especially important to avoid fuelling resistance to...

Product Name : Fetroja

Product Type : Miscellaneous

Upfront Cash : Undisclosed

June 15, 2022

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Details:

Publication of two studies in The Lancet Infectious Diseases journal has shown the efficacy and safety of FETROJA for some of the most difficult-to-treat Gram-negative bacterial infections, including nosocomial pneumonia, bloodstream infections, sepsis, and Complicated UTIs.


Lead Product(s): Cefiderocol sulfate tosylate,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 13, 2020

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04

Shionogi

Japan
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BIO Partnering at JPM
Not Confirmed

Shionogi

Japan
arrow
BIO Partnering at JPM
Not Confirmed

Details : Publication of two studies in The Lancet Infectious Diseases journal has shown the efficacy and safety of FETROJA for some of the most difficult-to-treat Gram-negative bacterial infections, including nosocomial pneumonia, bloodstream infections, sepsis, ...

Product Name : Fetroja

Product Type : Miscellaneous

Upfront Cash : Inapplicable

October 13, 2020

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Details:

U.S.FDA has approved a supplemental New Drug Application for FETROJA® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).


Lead Product(s): Cefiderocol sulfate tosylate,Linezolid

Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 28, 2020

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Shionogi

Japan
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BIO Partnering at JPM
Not Confirmed

Shionogi

Japan
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BIO Partnering at JPM
Not Confirmed

Details : U.S.FDA has approved a supplemental New Drug Application for FETROJA® (cefiderocol) for the treatment of patients 18 years of age or older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

Product Name : Fetroja

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 28, 2020

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Details:

The approval was based on the nonclinical data package, including the PK/PD data package, and data from three clinical studies in complicated UTI, nosocomial pneumonia and critically ill patients with confirmed carbapenem-resistant infection.


Lead Product(s): Cefiderocol sulfate tosylate,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 14, 2020

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Shionogi

Japan
arrow
BIO Partnering at JPM
Not Confirmed

Shionogi

Japan
arrow
BIO Partnering at JPM
Not Confirmed

Details : The approval was based on the nonclinical data package, including the PK/PD data package, and data from three clinical studies in complicated UTI, nosocomial pneumonia and critically ill patients with confirmed carbapenem-resistant infection.

Product Name : Fetroja

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 14, 2020

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Details:

FDA has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020.


Lead Product(s): Cefiderocol sulfate tosylate,Linezolid

Therapeutic Area: Infections and Infectious Diseases Brand Name: Fetroja

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 01, 2020

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Shionogi

Japan
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BIO Partnering at JPM
Not Confirmed

Shionogi

Japan
arrow
BIO Partnering at JPM
Not Confirmed

Details : FDA has accepted the company’s supplemental New Drug Application (sNDA) for FETROJA® (cefiderocol) and granted Priority Review designation with a Prescription Drug User Fee Act (PDUFA) date of September 27, 2020.

Product Name : Fetroja

Product Type : Miscellaneous

Upfront Cash : Inapplicable

June 01, 2020

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Patents & EXCLUSIVITIES

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US Patents

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SHIONOGI INC

Japan
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Not Confirmed

CEFIDEROCOL SULFATE TOSYLATE

US Patent Number : 9238657

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 209445

Patent Use Code : U-3470

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-11-14

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SHIONOGI INC

Japan
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Biotech Showcase
Not Confirmed

CEFIDEROCOL SULFATE TOSYLATE

US Patent Number : 9238657

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 209445

Patent Use Code : U-3471

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2033-11-14

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SHIONOGI INC

Japan
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Not Confirmed

CEFIDEROCOL SULFATE TOSYLATE

US Patent Number : 10004750

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 209445

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-09-03

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Biotech Showcase
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SHIONOGI INC

Japan
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Not Confirmed

CEFIDEROCOL SULFATE TOSYLATE

US Patent Number : 9949982

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 209445

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2035-09-03

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Biotech Showcase
Not Confirmed

SHIONOGI INC

Japan
arrow
Biotech Showcase
Not Confirmed

CEFIDEROCOL SULFATE TOSYLATE

US Patent Number : 9238657

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 209445

Patent Use Code : U-282

Delist Requested :

Patent Use Description : METHOD OF TREATING BAC...

Patent Expiration Date : 2033-11-14

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ABOUT THIS PAGE

Looking for 2009350-94-9 / Cefiderocol sulfate tosylate API manufacturers, exporters & distributors?

Cefiderocol sulfate tosylate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cefiderocol sulfate tosylate 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 Cefiderocol sulfate tosylate manufacturer or Cefiderocol sulfate tosylate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefiderocol sulfate tosylate manufacturer or Cefiderocol sulfate tosylate supplier.

PharmaCompass also assists you with knowing the Cefiderocol sulfate tosylate API Price utilized in the formulation of products. Cefiderocol sulfate tosylate API Price is not always fixed or binding as the Cefiderocol sulfate tosylate Price is obtained through a variety of data sources. The Cefiderocol sulfate tosylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cefiderocol sulfate tosylate

Synonyms

Gsk2696266d, S-649266d, Ttp8lbp45d, Cefiderocol sulfate tosylate [usan], Gsk-2696266d, 2135543-94-9

Cas Number

2009350-94-9

Cefiderocol sulfate tosylate Manufacturers

A Cefiderocol sulfate tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefiderocol sulfate tosylate, including repackagers and relabelers. The FDA regulates Cefiderocol sulfate tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefiderocol sulfate tosylate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Cefiderocol sulfate tosylate Suppliers

A Cefiderocol sulfate tosylate supplier is an individual or a company that provides Cefiderocol sulfate tosylate active pharmaceutical ingredient (API) or Cefiderocol sulfate tosylate finished formulations upon request. The Cefiderocol sulfate tosylate suppliers may include Cefiderocol sulfate tosylate API manufacturers, exporters, distributors and traders.

click here to find a list of Cefiderocol sulfate tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Cefiderocol sulfate tosylate 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 Cefiderocol sulfate tosylate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cefiderocol sulfate tosylate 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 Cefiderocol sulfate tosylate 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 Cefiderocol sulfate tosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cefiderocol sulfate tosylate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cefiderocol sulfate tosylate suppliers with NDC on PharmaCompass.

Cefiderocol sulfate tosylate GMP

Cefiderocol sulfate tosylate 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 Cefiderocol sulfate tosylate 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 Cefiderocol sulfate tosylate GMP manufacturer or Cefiderocol sulfate tosylate GMP API supplier for your needs.

Cefiderocol sulfate tosylate CoA

A Cefiderocol sulfate tosylate CoA (Certificate of Analysis) is a formal document that attests to Cefiderocol sulfate tosylate's compliance with Cefiderocol sulfate tosylate specifications and serves as a tool for batch-level quality control.

Cefiderocol sulfate tosylate CoA mostly includes findings from lab analyses of a specific batch. For each Cefiderocol sulfate tosylate 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.

Cefiderocol sulfate tosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cefiderocol sulfate tosylate EP), Cefiderocol sulfate tosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cefiderocol sulfate tosylate 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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