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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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South Africa

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16 RELATED EXCIPIENT COMPANIES

33EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Interleukin1 receptor antagonist (human isoform x reduced),n2-l-methionyl- (9ci)
Molecular Formula
C20H23N5O7S2
Molecular Weight
509.6  g/mol
InChI Key
HMLGSIZOMSVISS-ONJSNURVSA-N

Anakinra
1 2D Structure

Anakinra

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(7R)-7-[[(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(2,2-dimethylpropanoyloxymethoxyimino)acetyl]amino]-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
2.1.2 InChI
InChI=1S/C20H23N5O7S2/c1-5-9-6-33-16-12(15(27)25(16)13(9)17(28)29)23-14(26)11(10-7-34-19(21)22-10)24-32-8-31-18(30)20(2,3)4/h5,7,12,16H,1,6,8H2,2-4H3,(H2,21,22)(H,23,26)(H,28,29)/b24-11-/t12-,16?/m1/s1
2.1.3 InChI Key
HMLGSIZOMSVISS-ONJSNURVSA-N
2.1.4 Canonical SMILES
CC(C)(C)C(=O)OCON=C(C1=CSC(=N1)N)C(=O)NC2C3N(C2=O)C(=C(CS3)C=C)C(=O)O
2.1.5 Isomeric SMILES
CC(C)(C)C(=O)OCO/N=C(/C1=CSC(=N1)N)\C(=O)N[C@H]2C3N(C2=O)C(=C(CS3)C=C)C(=O)O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Interleukin1 Receptor Antagonist (human Isoform X Reduced),n2-l-methionyl- (9ci)

2.3 Create Date
2015-02-16
3 Chemical and Physical Properties
Molecular Weight 509.6 g/mol
Molecular Formula C20H23N5O7S2
XLogP31.1
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count12
Rotatable Bond Count10
Exact Mass509.10389044 g/mol
Monoisotopic Mass509.10389044 g/mol
Topological Polar Surface Area227 Ų
Heavy Atom Count34
Formal Charge0
Complexity961
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1

FDA Orange Book

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BIOVITRUM AB

Sweden
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BIOVITRUM AB

Sweden
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ANAKINRA

Brand Name : KINERET

Dosage Form : VIAL; SUBCUTANEOUS

Dosage Strength : 10MIU/VIAL

Approval Date :

Application Number : 103950

RX/OTC/DISCN :

RLD :

TE Code :

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02

BIOVITRUM AB

Sweden
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BIOVITRUM AB

Sweden
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ANAKINRA

Brand Name : KINERET

Dosage Form : VIAL; SUBCUTANEOUS

Dosage Strength : 18MIU/VIAL

Approval Date :

Application Number : 103950

RX/OTC/DISCN :

RLD :

TE Code :

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03

BIOVITRUM AB

Sweden
PharmaVenue
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BIOVITRUM AB

Sweden
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PharmaVenue
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ANAKINRA

Brand Name : KINERET

Dosage Form : VIAL; SUBCUTANEOUS

Dosage Strength : 25MIU/VIAL

Approval Date :

Application Number : 103950

RX/OTC/DISCN :

RLD :

TE Code :

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Europe

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Orifarm AS

Denmark
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Orifarm AS

Denmark
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Anakinra

Brand Name : Kineret

Dosage Form : Injection fluid, resolution

Dosage Strength : 100 mg/0.67 ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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anakinra

Brand Name : Kineret

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 100 MG / 0.67 ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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anakinra

Brand Name : Kineret

Dosage Form : SOLUTION FOR INJECTION, PRE-FILLED SYRINGE

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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anakinra

Brand Name : Kineret

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 100 MG

Packaging :

Approval Date :

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Regulatory Info :

Registration Country : Sweden

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Anakinra

Brand Name : Kineret

Dosage Form : Anakinra 100Mg 0.67 Ml 7 Joined The Parenteral Use

Dosage Strength : 7 Syringes SC 100 mg 0,67 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Anakinra

Brand Name : Kineret

Dosage Form : Anakinra 100Mg 0.67 Ml 7 Joined The Parenteral Use

Dosage Strength : 7 Syringes SC 100 mg 0,67 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Anakinra

Brand Name : Kineret

Dosage Form : Injection fluid, resolution

Dosage Strength : 100 mg/0.67 ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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08

PharmaVenue
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PharmaVenue
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Anakinra

Brand Name : Kineret

Dosage Form : Injection fluid, resolution

Dosage Strength : 100 mg/0.67 ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

blank

09

PharmaVenue
Not Confirmed
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PharmaVenue
Not Confirmed

Anakinra

Brand Name : Kineret

Dosage Form : Injection fluid, resolution

Dosage Strength : 100 mg/0.67 ml

Packaging : Finish filled syringe

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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ABOUT THIS PAGE

Anakinra Manufacturers

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

Anakinra Suppliers

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

Anakinra GMP

Anakinra 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 Anakinra 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 Anakinra GMP manufacturer or Anakinra GMP API supplier for your needs.

Anakinra CoA

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

Anakinra CoA mostly includes findings from lab analyses of a specific batch. For each Anakinra 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.

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