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Rochem International Inc
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ganciclovir 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 Ganciclovir manufacturer or Ganciclovir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ganciclovir manufacturer or Ganciclovir supplier.
PharmaCompass also assists you with knowing the Ganciclovir API Price utilized in the formulation of products. Ganciclovir API Price is not always fixed or binding as the Ganciclovir Price is obtained through a variety of data sources. The Ganciclovir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one, including repackagers and relabelers. The FDA regulates 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one supplier is an individual or a company that provides 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one active pharmaceutical ingredient (API) or 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one finished formulations upon request. The 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one suppliers may include 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one API manufacturers, exporters, distributors and traders.
click here to find a list of 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one DMF (Drug Master File) is a document detailing the whole manufacturing process of 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one active pharmaceutical ingredient (API) in detail. Different forms of 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one DMFs exist exist since differing nations have different regulations, such as 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one DMF submitted to regulatory agencies in the US is known as a USDMF. 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one USDMF includes data on 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one Drug Master File in Japan (2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one JDMF) empowers 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one JDMF during the approval evaluation for pharmaceutical products. At the time of 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one suppliers with JDMF on PharmaCompass.
A 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one CEP of the European Pharmacopoeia monograph is often referred to as a 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one Certificate of Suitability (COS). The purpose of a 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one to their clients by showing that a 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one CEP has been issued for it. The manufacturer submits a 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one CEP (COS) as part of the market authorization procedure, and it takes on the role of a 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one CEP holder for the record. Additionally, the data presented in the 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one DMF.
A 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one suppliers with CEP (COS) on PharmaCompass.
A 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one written confirmation (2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one WC) is an official document issued by a regulatory agency to a 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one manufacturer, verifying that the manufacturing facility of a 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one APIs or 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one finished pharmaceutical products to another nation, regulatory agencies frequently require a 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one WC (written confirmation) as part of the regulatory process.
click here to find a list of 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one suppliers with NDC on PharmaCompass.
2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one GMP manufacturer or 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one GMP API supplier for your needs.
A 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one CoA (Certificate of Analysis) is a formal document that attests to 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one's compliance with 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one specifications and serves as a tool for batch-level quality control.
2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one CoA mostly includes findings from lab analyses of a specific batch. For each 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one 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.
2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one may be tested according to a variety of international standards, such as European Pharmacopoeia (2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one EP), 2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one JP (Japanese Pharmacopeia) and the US Pharmacopoeia (2-amino-9-(1,3-dihydroxypropan-2-yloxymethyl)-3H-purin-6-one USP).
