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