Synopsis
Synopsis
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USDMF
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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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Molecular Weight | 730.7 g/mol |
---|---|
Molecular Formula | C27H46N4O19 |
XLogP3 | -8.6 |
Hydrogen Bond Donor Count | 12 |
Hydrogen Bond Acceptor Count | 20 |
Rotatable Bond Count | 19 |
Exact Mass | 730.27562525 g/mol |
Monoisotopic Mass | 730.27562525 g/mol |
Topological Polar Surface Area | 365 Ų |
Heavy Atom Count | 50 |
Formal Charge | 0 |
Complexity | 1170 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 13 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Pelgraz
Dosage Form : Injectable Solution In Pre-Filled Injector
Dosage Strength : 6MG
Packaging :
Approval Date : 2019-12-10
Application Number : 1181313002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Pelgraz
Dosage Form : Injectable Solution In Pre-Filled Syringe
Dosage Strength : 6MG
Packaging :
Approval Date : 2018-10-31
Application Number : 1181313001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Neulasta
Dosage Form : Solution For Injection
Dosage Strength :
Packaging :
Approval Date : 22/08/2002
Application Number : 20020822000082
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Neulasta
Dosage Form : Solution For Injection
Dosage Strength : 6mg/0.6ml
Packaging :
Approval Date : 01/09/2003
Application Number : 56326
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Neulasta
Dosage Form : Injectable Solution
Dosage Strength : 6MG
Packaging :
Approval Date : 2009-09-17
Application Number : 02227004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Generic Production in Germany, for Exp...
Registration Country : Germany
Brand Name :
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 300MCG
Packaging : Vial (Box)
Approval Date :
Application Number : 103353
Regulatory Info : Generic Production in Germany, for Export Markets
Registration Country : Germany
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Neupopeg
Dosage Form : Solution For Injection
Dosage Strength :
Packaging :
Approval Date : 22/08/2002
Application Number : 20020822000099
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Stimufend
Dosage Form : Solution For Injection
Dosage Strength :
Packaging :
Approval Date : 28/03/2022
Application Number : 20200428000079
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Pelmeg
Dosage Form : Solution For Injection
Dosage Strength :
Packaging :
Approval Date : 20/11/2018
Application Number : 20170912000017
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Ziextenzo
Dosage Form : Solution For Injection
Dosage Strength : 6mg/0.6ml
Packaging :
Approval Date : 20/01/2020
Application Number : 67569
Regulatory Info : Allowed
Registration Country : Switzerland
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PharmaCompass offers a list of Pegfilgrastim 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 Pegfilgrastim manufacturer or Pegfilgrastim supplier for your needs.
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PharmaCompass also assists you with knowing the Pegfilgrastim API Price utilized in the formulation of products. Pegfilgrastim API Price is not always fixed or binding as the Pegfilgrastim Price is obtained through a variety of data sources. The Pegfilgrastim Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Neulasta manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Neulasta, including repackagers and relabelers. The FDA regulates Neulasta manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Neulasta 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 Neulasta manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Neulasta supplier is an individual or a company that provides Neulasta active pharmaceutical ingredient (API) or Neulasta finished formulations upon request. The Neulasta suppliers may include Neulasta API manufacturers, exporters, distributors and traders.
click here to find a list of Neulasta suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
Neulasta 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 Neulasta 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 Neulasta GMP manufacturer or Neulasta GMP API supplier for your needs.
A Neulasta CoA (Certificate of Analysis) is a formal document that attests to Neulasta's compliance with Neulasta specifications and serves as a tool for batch-level quality control.
Neulasta CoA mostly includes findings from lab analyses of a specific batch. For each Neulasta 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.
Neulasta may be tested according to a variety of international standards, such as European Pharmacopoeia (Neulasta EP), Neulasta JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Neulasta USP).