Synopsis
Synopsis
0
USDMF
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
DRUG PRODUCT COMPOSITIONS
Regulatory FDF Prices
NA
0
Stock Recap #PipelineProspector


| 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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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Pegylastin
Dosage Form : PFS
Dosage Strength : 6mg/ml
Packaging : 0.6X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Neulastim ®
Dosage Form : PFS
Dosage Strength : 6mg/0.6ml
Packaging : 0.6X1mg/0.6ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

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Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Ziextenzo
Dosage Form : PFS
Dosage Strength : 6mg/0.6ml
Packaging : 0.6X1mg/0.6ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Regulatory Info : Originator
Registration Country : South Africa
Brand Name : LONQUEX
Dosage Form : PFS
Dosage Strength : 6MG/0.6ML
Packaging : 0.6X1MG/0.6ML
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa

Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Pegfilgrastim Eurolab
Dosage Form : PFS
Dosage Strength : 6mg/0.6ml
Packaging : 0.6X1mg/0.6ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

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Corporate PDF
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Fulphila
Dosage Form : PFS
Dosage Strength : 6mg/0.6ml
Packaging : 0.6X1mg/0.6ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa

Portfolio PDF
Product Web Link
Virtual Booth
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Website
Corporate PDF
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Regulatory Info :
Registration Country : Iran
Brand Name : PegaGen
Dosage Form : Injectable
Dosage Strength : 6MG
Packaging : PFS
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran

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Packaging : PFS
Regulatory Info :
Dosage : Injectable
Dosage Strength : 6MG
Brand Name : PegaGen
Approval Date :
Application Number :
Registration Country : Iran

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Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 6MG/0.6ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China

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Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 6MG/0.6ML
Brand Name :
Approval Date :
Application Number :
Registration Country : China

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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, and more, enabling you to easily find the right Pegfilgrastim manufacturer or Pegfilgrastim supplier for your needs.
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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, and COA 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, and COA 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, 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).