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