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