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ABOUT THIS PAGE
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PharmaCompass offers a list of Iguratimod 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 Iguratimod manufacturer or Iguratimod supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Iguratimod manufacturer or Iguratimod supplier.
PharmaCompass also assists you with knowing the Iguratimod API Price utilized in the formulation of products. Iguratimod API Price is not always fixed or binding as the Iguratimod Price is obtained through a variety of data sources. The Iguratimod Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Iguratimod manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iguratimod, including repackagers and relabelers. The FDA regulates Iguratimod manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iguratimod 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 Iguratimod manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iguratimod supplier is an individual or a company that provides Iguratimod active pharmaceutical ingredient (API) or Iguratimod finished formulations upon request. The Iguratimod suppliers may include Iguratimod API manufacturers, exporters, distributors and traders.
click here to find a list of Iguratimod suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iguratimod DMF (Drug Master File) is a document detailing the whole manufacturing process of Iguratimod active pharmaceutical ingredient (API) in detail. Different forms of Iguratimod DMFs exist exist since differing nations have different regulations, such as Iguratimod USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iguratimod DMF submitted to regulatory agencies in the US is known as a USDMF. Iguratimod USDMF includes data on Iguratimod's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iguratimod USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iguratimod 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 Iguratimod Drug Master File in Japan (Iguratimod JDMF) empowers Iguratimod 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 Iguratimod JDMF during the approval evaluation for pharmaceutical products. At the time of Iguratimod 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 Iguratimod suppliers with JDMF on PharmaCompass.
Iguratimod 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 Iguratimod 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 Iguratimod GMP manufacturer or Iguratimod GMP API supplier for your needs.
A Iguratimod CoA (Certificate of Analysis) is a formal document that attests to Iguratimod's compliance with Iguratimod specifications and serves as a tool for batch-level quality control.
Iguratimod CoA mostly includes findings from lab analyses of a specific batch. For each Iguratimod 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.
Iguratimod may be tested according to a variety of international standards, such as European Pharmacopoeia (Iguratimod EP), Iguratimod JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Iguratimod USP).
