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Looking for 775304-57-9 / Ataluren API manufacturers, exporters & distributors?

Ataluren manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ataluren

Synonyms

775304-57-9, Ptc124, 3-(5-(2-fluorophenyl)-1,2,4-oxadiazol-3-yl)benzoic acid, 3-[5-(2-fluorophenyl)-1,2,4-oxadiazol-3-yl]benzoic acid, Ptc-124, Ataluren (ptc124)

Cas Number

775304-57-9

Unique Ingredient Identifier (UNII)

K16AME9I3V

About Ataluren

Ataluren is a novel, orally administered drug that targets nonsense mutations. Ataluren is approved for use by the European Medicines Agency to treat Duchenne Muscular Dystrophy in patients aged 5 years and older who are able to walk. More specifically, ataluren is used in the small group of patients whose disease is caused by a specific genetic defect (called a nonsense mutation) in the dystrophin gene. This drug does not yet have approval by the US Food and Drug Administration or by Health Canada for any indications.

Ataluren Manufacturers

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

Ataluren Suppliers

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

Ataluren NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ataluren as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ataluren API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Ataluren as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Ataluren and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ataluren NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Ataluren suppliers with NDC on PharmaCompass.

Ataluren GMP

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

Ataluren CoA

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

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

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