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Looking for 1585984-95-7 / Pegvaliase API manufacturers, exporters & distributors?

Pegvaliase manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Pegvaliase 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 Pegvaliase manufacturer or Pegvaliase supplier for your needs.

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

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

API | Excipient name

Pegvaliase

Synonyms

Ravpal-peg, Peg-pal, Pegvaliase-pqpz, 1585984-95-7, Pegvaliase [inn], Unii-n6uah27euv

Cas Number

1585984-95-7

About Pegvaliase

Pegvaliase is a recombinant phenylalanine ammonia lyase (PAL) enzyme derived from Anabaena variabilis that converts phenylalanine to ammonia and trans-cinnamic acid. Both the U.S. Food and Drug Administration and European Medicines Agency approved pegvaliase-pqpz in May 2018 for the treatment of adult patients with phenylketonuria (PKU). Phenylketonuria is a rare autosomal recessive disorder that is characterized by deficiency of the enzyme phenylalanine hydroxylase (PAH) and affects about 1 in 10,000 to 15,000 people in the United States. PAH deficiency and inability to break down an amino acid phenylalanine (Phe) leads to elevated blood phenylalanine concentrations and accumulation of neurotoxic Phe in the brain, causing chronic intellectual, neurodevelopmental and psychiatric disabilities if untreated. Individuals with PKU also need to be under a strictly restricted diet as Phe is present in foods and products with high-intensity sweeteners. The primary goal of lifelong treatment of PKU, as recommended by the American College of Medical Genetics and Genomics (ACMG) guidelines, is to maintain blood Phe concentration in the range of 120 mol/L to 3690 mol/L. Pegvaliase-pqpz, or PEGylated pegvaliase, is used as a novel enzyme substitution therapy and is marketed as Palynziq for subcutanoues injection. It is advantageous over currently available management therapies for PKU, such as [DB00360], that are ineffective to many patients due to long-term adherence issues or inadequate Phe-lowering effects. The presence of a PEG moiety in pegvaliase-pqpz allows a reduced immune response and improved pharmacodynamic stability.

Pegvaliase Manufacturers

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

Pegvaliase Suppliers

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

Pegvaliase GMP

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

Pegvaliase CoA

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

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

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