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PharmaCompass offers a list of Pirfenidone 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 Pirfenidone manufacturer or Pirfenidone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pirfenidone manufacturer or Pirfenidone supplier.
PharmaCompass also assists you with knowing the Pirfenidone API Price utilized in the formulation of products. Pirfenidone API Price is not always fixed or binding as the Pirfenidone Price is obtained through a variety of data sources. The Pirfenidone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pirfenidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pirfenidone, including repackagers and relabelers. The FDA regulates Pirfenidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pirfenidone 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 Pirfenidone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pirfenidone supplier is an individual or a company that provides Pirfenidone active pharmaceutical ingredient (API) or Pirfenidone finished formulations upon request. The Pirfenidone suppliers may include Pirfenidone API manufacturers, exporters, distributors and traders.
click here to find a list of Pirfenidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pirfenidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Pirfenidone active pharmaceutical ingredient (API) in detail. Different forms of Pirfenidone DMFs exist exist since differing nations have different regulations, such as Pirfenidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pirfenidone DMF submitted to regulatory agencies in the US is known as a USDMF. Pirfenidone USDMF includes data on Pirfenidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pirfenidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pirfenidone 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 Pirfenidone Drug Master File in Japan (Pirfenidone JDMF) empowers Pirfenidone 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 Pirfenidone JDMF during the approval evaluation for pharmaceutical products. At the time of Pirfenidone 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 Pirfenidone suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pirfenidone Drug Master File in Korea (Pirfenidone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pirfenidone. The MFDS reviews the Pirfenidone KDMF as part of the drug registration process and uses the information provided in the Pirfenidone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pirfenidone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Pirfenidone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pirfenidone suppliers with KDMF on PharmaCompass.
A Pirfenidone CEP of the European Pharmacopoeia monograph is often referred to as a Pirfenidone Certificate of Suitability (COS). The purpose of a Pirfenidone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pirfenidone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pirfenidone to their clients by showing that a Pirfenidone CEP has been issued for it. The manufacturer submits a Pirfenidone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pirfenidone CEP holder for the record. Additionally, the data presented in the Pirfenidone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pirfenidone DMF.
A Pirfenidone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pirfenidone CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Pirfenidone suppliers with CEP (COS) on PharmaCompass.
A Pirfenidone written confirmation (Pirfenidone WC) is an official document issued by a regulatory agency to a Pirfenidone manufacturer, verifying that the manufacturing facility of a Pirfenidone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pirfenidone APIs or Pirfenidone finished pharmaceutical products to another nation, regulatory agencies frequently require a Pirfenidone WC (written confirmation) as part of the regulatory process.
click here to find a list of Pirfenidone 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 Pirfenidone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pirfenidone 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 Pirfenidone 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 Pirfenidone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pirfenidone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pirfenidone suppliers with NDC on PharmaCompass.
Pirfenidone 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 Pirfenidone 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 Pirfenidone GMP manufacturer or Pirfenidone GMP API supplier for your needs.
A Pirfenidone CoA (Certificate of Analysis) is a formal document that attests to Pirfenidone's compliance with Pirfenidone specifications and serves as a tool for batch-level quality control.
Pirfenidone CoA mostly includes findings from lab analyses of a specific batch. For each Pirfenidone 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.
Pirfenidone may be tested according to a variety of international standards, such as European Pharmacopoeia (Pirfenidone EP), Pirfenidone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pirfenidone USP).
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