US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Pentoxifylline 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 Pentoxifylline manufacturer or Pentoxifylline supplier for your needs.
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PharmaCompass also assists you with knowing the Pentoxifylline API Price utilized in the formulation of products. Pentoxifylline API Price is not always fixed or binding as the Pentoxifylline Price is obtained through a variety of data sources. The Pentoxifylline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Pentoxifylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentoxifylline, including repackagers and relabelers. The FDA regulates Pentoxifylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentoxifylline API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Pentoxifylline supplier is an individual or a company that provides Pentoxifylline active pharmaceutical ingredient (API) or Pentoxifylline finished formulations upon request. The Pentoxifylline suppliers may include Pentoxifylline API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Pentoxifylline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentoxifylline DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentoxifylline active pharmaceutical ingredient (API) in detail. Different forms of Pentoxifylline DMFs exist exist since differing nations have different regulations, such as Pentoxifylline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentoxifylline DMF submitted to regulatory agencies in the US is known as a USDMF. Pentoxifylline USDMF includes data on Pentoxifylline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentoxifylline USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Pentoxifylline Drug Master File in Korea (Pentoxifylline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pentoxifylline. The MFDS reviews the Pentoxifylline KDMF as part of the drug registration process and uses the information provided in the Pentoxifylline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pentoxifylline 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 Pentoxifylline API can apply through the Korea Drug Master File (KDMF).
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A Pentoxifylline CEP of the European Pharmacopoeia monograph is often referred to as a Pentoxifylline Certificate of Suitability (COS). The purpose of a Pentoxifylline CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pentoxifylline EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pentoxifylline to their clients by showing that a Pentoxifylline CEP has been issued for it. The manufacturer submits a Pentoxifylline CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pentoxifylline CEP holder for the record. Additionally, the data presented in the Pentoxifylline CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pentoxifylline DMF.
A Pentoxifylline CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pentoxifylline CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Pentoxifylline written confirmation (Pentoxifylline WC) is an official document issued by a regulatory agency to a Pentoxifylline manufacturer, verifying that the manufacturing facility of a Pentoxifylline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pentoxifylline APIs or Pentoxifylline finished pharmaceutical products to another nation, regulatory agencies frequently require a Pentoxifylline WC (written confirmation) as part of the regulatory process.
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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 Pentoxifylline as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pentoxifylline 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 Pentoxifylline 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 Pentoxifylline and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pentoxifylline NDC to their finished compounded human drug products, they may choose to do so.
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Pentoxifylline 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 Pentoxifylline 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 Pentoxifylline GMP manufacturer or Pentoxifylline GMP API supplier for your needs.
A Pentoxifylline CoA (Certificate of Analysis) is a formal document that attests to Pentoxifylline's compliance with Pentoxifylline specifications and serves as a tool for batch-level quality control.
Pentoxifylline CoA mostly includes findings from lab analyses of a specific batch. For each Pentoxifylline 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.
Pentoxifylline may be tested according to a variety of international standards, such as European Pharmacopoeia (Pentoxifylline EP), Pentoxifylline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pentoxifylline USP).