01 1F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.
01 1ATALUREN
01 1Italy
NDC Package Code : 48087-0138
Start Marketing Date : 2018-11-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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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.
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.
click here to find a list of Ataluren manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
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.
click here to find a list of Ataluren suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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).
The FDA updates the NDC directory daily. The NDC numbers for Ataluren API and other APIs are published in this directory by the FDA.
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.
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.
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