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Looking for 2055732-84-6 / Viltolarsen API manufacturers, exporters & distributors?

Viltolarsen manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Viltolarsen

Synonyms

Ncnp-01, Gtpl11430, Ns-065

Cas Number

2055732-84-6

About Viltolarsen

Duchenne muscular dystrophy (DMD) is an X-linked recessive allelic disorder characterized by a lack of functional dystrophin protein, which leads to progressive ambulatory, pulmonary, and cardiac function and is invariably fatal. A related, albeit a less severe, form of muscular dystrophy known as Becker muscular dystrophy (BMD) is characterized by the production of shortened and partially functional dystrophin protein. Although corticosteroids are effective in slowing disease progression in both DMD and BMD patients, they do not address the underlying molecular pathogenesis. The application of antisense oligonucleotides in DMD patients with specific mutations allows for exon skipping, which retains a productive reading frame and results in the production of truncated BMD-like dystrophin proteins. These shortened forms of dystrophin can restore partial muscle function and slow the progression of DMD. Viltolarsen is a phosphorodiamidate morpholino oligonucleotide (PMO); PMOs are oligonucleotides in which the five-membered ribofuranosyl ring is replaced with a six-membered morpholino ring, and the phosphodiester links between nucleotides are replaced with a phosphorodiamidate linkage. In this manner, PMOs are much less susceptible to endo- and exonucleases and exhibit drastically reduced metabolic degradation compared to traditional synthetic oligonucleotides. Hence, viltolarsen is similar to another PMO, [eteplirsen], which gained FDA approval on September 19, 2016; however, [eteplirsen] is specific for exon 51 skipping while viltolarsen is specific for exon 53 skipping. Viltolarsen was granted accelerated FDA approval on August 12, 2020, based on data showing an increase in dystrophin levels in skeletal muscle of patients treated with viltolarsen; this approval is contingent on further verification in confirmatory trials. Viltolarsen was developed by Nippon Shinyaku Co LTD and is being marketed under the name VILTEPSO.

Viltolarsen Manufacturers

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

Viltolarsen Suppliers

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

Viltolarsen GMP

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

Viltolarsen CoA

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

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

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