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ABOUT THIS PAGE
A Folotyn manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Folotyn, including repackagers and relabelers. The FDA regulates Folotyn manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Folotyn 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 Folotyn manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Folotyn supplier is an individual or a company that provides Folotyn active pharmaceutical ingredient (API) or Folotyn finished formulations upon request. The Folotyn suppliers may include Folotyn API manufacturers, exporters, distributors and traders.
click here to find a list of Folotyn suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Folotyn DMF (Drug Master File) is a document detailing the whole manufacturing process of Folotyn active pharmaceutical ingredient (API) in detail. Different forms of Folotyn DMFs exist exist since differing nations have different regulations, such as Folotyn USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Folotyn DMF submitted to regulatory agencies in the US is known as a USDMF. Folotyn USDMF includes data on Folotyn's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Folotyn USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Folotyn suppliers with USDMF on PharmaCompass.
A Folotyn written confirmation (Folotyn WC) is an official document issued by a regulatory agency to a Folotyn manufacturer, verifying that the manufacturing facility of a Folotyn active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Folotyn APIs or Folotyn finished pharmaceutical products to another nation, regulatory agencies frequently require a Folotyn WC (written confirmation) as part of the regulatory process.
click here to find a list of Folotyn suppliers with Written Confirmation (WC) 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 Folotyn as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Folotyn 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 Folotyn 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 Folotyn and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Folotyn NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Folotyn suppliers with NDC on PharmaCompass.
Folotyn 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 Folotyn 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 Folotyn GMP manufacturer or Folotyn GMP API supplier for your needs.
A Folotyn CoA (Certificate of Analysis) is a formal document that attests to Folotyn's compliance with Folotyn specifications and serves as a tool for batch-level quality control.
Folotyn CoA mostly includes findings from lab analyses of a specific batch. For each Folotyn 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.
Folotyn may be tested according to a variety of international standards, such as European Pharmacopoeia (Folotyn EP), Folotyn JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Folotyn USP).
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