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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Istradefylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Istradefylline, including repackagers and relabelers. The FDA regulates Istradefylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Istradefylline 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 Istradefylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Istradefylline supplier is an individual or a company that provides Istradefylline active pharmaceutical ingredient (API) or Istradefylline finished formulations upon request. The Istradefylline suppliers may include Istradefylline API manufacturers, exporters, distributors and traders.
click here to find a list of Istradefylline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Istradefylline DMF (Drug Master File) is a document detailing the whole manufacturing process of Istradefylline active pharmaceutical ingredient (API) in detail. Different forms of Istradefylline DMFs exist exist since differing nations have different regulations, such as Istradefylline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Istradefylline DMF submitted to regulatory agencies in the US is known as a USDMF. Istradefylline USDMF includes data on Istradefylline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Istradefylline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Istradefylline suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Istradefylline Drug Master File in Japan (Istradefylline JDMF) empowers Istradefylline API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Istradefylline JDMF during the approval evaluation for pharmaceutical products. At the time of Istradefylline JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Istradefylline suppliers with JDMF 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 Istradefylline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Istradefylline 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 Istradefylline 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 Istradefylline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Istradefylline NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Istradefylline suppliers with NDC on PharmaCompass.
Istradefylline 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 Istradefylline 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 Istradefylline GMP manufacturer or Istradefylline GMP API supplier for your needs.
A Istradefylline CoA (Certificate of Analysis) is a formal document that attests to Istradefylline's compliance with Istradefylline specifications and serves as a tool for batch-level quality control.
Istradefylline CoA mostly includes findings from lab analyses of a specific batch. For each Istradefylline 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.
Istradefylline may be tested according to a variety of international standards, such as European Pharmacopoeia (Istradefylline EP), Istradefylline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Istradefylline USP).
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