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