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