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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 300MG
USFDA APPLICATION NUMBER - 16084
DOSAGE - TABLET;ORAL - 200MG;200MG
USFDA APPLICATION NUMBER - 209203
DOSAGE - TABLET;ORAL - 300MG;200MG
USFDA APPLICATION NUMBER - 209203
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ABOUT THIS PAGE
46
PharmaCompass offers a list of Allopurinol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Allopurinol manufacturer or Allopurinol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Allopurinol manufacturer or Allopurinol supplier.
A Apurol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apurol, including repackagers and relabelers. The FDA regulates Apurol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apurol 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 Apurol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Apurol supplier is an individual or a company that provides Apurol active pharmaceutical ingredient (API) or Apurol finished formulations upon request. The Apurol suppliers may include Apurol API manufacturers, exporters, distributors and traders.
click here to find a list of Apurol suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Apurol DMF (Drug Master File) is a document detailing the whole manufacturing process of Apurol active pharmaceutical ingredient (API) in detail. Different forms of Apurol DMFs exist exist since differing nations have different regulations, such as Apurol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Apurol DMF submitted to regulatory agencies in the US is known as a USDMF. Apurol USDMF includes data on Apurol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Apurol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Apurol 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 Apurol Drug Master File in Japan (Apurol JDMF) empowers Apurol 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 Apurol JDMF during the approval evaluation for pharmaceutical products. At the time of Apurol 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 Apurol 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 Apurol Drug Master File in Korea (Apurol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Apurol. The MFDS reviews the Apurol KDMF as part of the drug registration process and uses the information provided in the Apurol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Apurol 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 Apurol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Apurol suppliers with KDMF on PharmaCompass.
A Apurol CEP of the European Pharmacopoeia monograph is often referred to as a Apurol Certificate of Suitability (COS). The purpose of a Apurol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Apurol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Apurol to their clients by showing that a Apurol CEP has been issued for it. The manufacturer submits a Apurol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Apurol CEP holder for the record. Additionally, the data presented in the Apurol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Apurol DMF.
A Apurol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Apurol 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 Apurol suppliers with CEP (COS) on PharmaCompass.
A Apurol written confirmation (Apurol WC) is an official document issued by a regulatory agency to a Apurol manufacturer, verifying that the manufacturing facility of a Apurol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Apurol APIs or Apurol finished pharmaceutical products to another nation, regulatory agencies frequently require a Apurol WC (written confirmation) as part of the regulatory process.
click here to find a list of Apurol 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 Apurol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Apurol 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 Apurol 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 Apurol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Apurol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Apurol suppliers with NDC on PharmaCompass.
Apurol 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 Apurol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Apurol GMP manufacturer or Apurol GMP API supplier for your needs.
A Apurol CoA (Certificate of Analysis) is a formal document that attests to Apurol's compliance with Apurol specifications and serves as a tool for batch-level quality control.
Apurol CoA mostly includes findings from lab analyses of a specific batch. For each Apurol 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.
Apurol may be tested according to a variety of international standards, such as European Pharmacopoeia (Apurol EP), Apurol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Apurol USP).
