01 1Loba biotech GmbH
01 13 4 Diaminopyridine
01 1Austria
NDC Package Code : 62668-3331
Start Marketing Date : 2018-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Amifampridine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amifampridine, including repackagers and relabelers. The FDA regulates Amifampridine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amifampridine 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 Amifampridine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amifampridine supplier is an individual or a company that provides Amifampridine active pharmaceutical ingredient (API) or Amifampridine finished formulations upon request. The Amifampridine suppliers may include Amifampridine API manufacturers, exporters, distributors and traders.
click here to find a list of Amifampridine 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 Amifampridine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amifampridine 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 Amifampridine 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 Amifampridine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amifampridine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amifampridine suppliers with NDC on PharmaCompass.
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