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