Synopsis
Synopsis
0
API Suppliers
0
USDMF
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
Listed Suppliers
0
API
0
FDF
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. Pegunigalsidase-alfa
2. Q27270744
| Molecular Weight | 560.6 g/mol |
|---|---|
| Molecular Formula | C24H44N6O9 |
| XLogP3 | -8 |
| Hydrogen Bond Donor Count | 8 |
| Hydrogen Bond Acceptor Count | 11 |
| Rotatable Bond Count | 24 |
| Exact Mass | 560.31697700 g/mol |
| Monoisotopic Mass | 560.31697700 g/mol |
| Topological Polar Surface Area | 252 Ų |
| Heavy Atom Count | 39 |
| Formal Charge | 0 |
| Complexity | 719 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Treatment of Fabry disease
A - Alimentary tract and metabolism
A16 - Other alimentary tract and metabolism products
A16A - Other alimentary tract and metabolism products
A16AB - Enzymes
A16AB20 - Pegunigalsidase alfa
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
ABOUT THIS PAGE
A Pegunigalsidase alfa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pegunigalsidase alfa, including repackagers and relabelers. The FDA regulates Pegunigalsidase alfa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pegunigalsidase alfa API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Pegunigalsidase alfa supplier is an individual or a company that provides Pegunigalsidase alfa active pharmaceutical ingredient (API) or Pegunigalsidase alfa finished formulations upon request. The Pegunigalsidase alfa suppliers may include Pegunigalsidase alfa API manufacturers, exporters, distributors and traders.
Pegunigalsidase alfa 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 Pegunigalsidase alfa 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 Pegunigalsidase alfa GMP manufacturer or Pegunigalsidase alfa GMP API supplier for your needs.
A Pegunigalsidase alfa CoA (Certificate of Analysis) is a formal document that attests to Pegunigalsidase alfa's compliance with Pegunigalsidase alfa specifications and serves as a tool for batch-level quality control.
Pegunigalsidase alfa CoA mostly includes findings from lab analyses of a specific batch. For each Pegunigalsidase alfa 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.
Pegunigalsidase alfa may be tested according to a variety of international standards, such as European Pharmacopoeia (Pegunigalsidase alfa EP), Pegunigalsidase alfa JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pegunigalsidase alfa USP).
LOOKING FOR A SUPPLIER?
