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KDMF
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DRUG PRODUCT COMPOSITIONS
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API SUPPLIERS
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USDMF
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API Imports and Exports
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Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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Direct Compression
Thickeners and Stabilizers
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Granulation
Co-Processed Excipients
Chewable & Orodispersible Aids
Parenteral
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Lubricants & Glidants
Coating Systems & Additives
Solubilizers
Controlled & Modified Release
Empty Capsules
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API Stability Enhancers
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Global Sales Information
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
A Ganciclovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganciclovir, including repackagers and relabelers. The FDA regulates Ganciclovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganciclovir 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 Ganciclovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganciclovir supplier is an individual or a company that provides Ganciclovir active pharmaceutical ingredient (API) or Ganciclovir finished formulations upon request. The Ganciclovir suppliers may include Ganciclovir API manufacturers, exporters, distributors and traders.
click here to find a list of Ganciclovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ganciclovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Ganciclovir active pharmaceutical ingredient (API) in detail. Different forms of Ganciclovir DMFs exist exist since differing nations have different regulations, such as Ganciclovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ganciclovir DMF submitted to regulatory agencies in the US is known as a USDMF. Ganciclovir USDMF includes data on Ganciclovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ganciclovir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ganciclovir 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 Ganciclovir Drug Master File in Japan (Ganciclovir JDMF) empowers Ganciclovir 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 Ganciclovir JDMF during the approval evaluation for pharmaceutical products. At the time of Ganciclovir 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 Ganciclovir suppliers with JDMF on PharmaCompass.
A Ganciclovir CEP of the European Pharmacopoeia monograph is often referred to as a Ganciclovir Certificate of Suitability (COS). The purpose of a Ganciclovir CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ganciclovir EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ganciclovir to their clients by showing that a Ganciclovir CEP has been issued for it. The manufacturer submits a Ganciclovir CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ganciclovir CEP holder for the record. Additionally, the data presented in the Ganciclovir CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ganciclovir DMF.
A Ganciclovir CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ganciclovir 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 Ganciclovir suppliers with CEP (COS) on PharmaCompass.
A Ganciclovir written confirmation (Ganciclovir WC) is an official document issued by a regulatory agency to a Ganciclovir manufacturer, verifying that the manufacturing facility of a Ganciclovir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ganciclovir APIs or Ganciclovir finished pharmaceutical products to another nation, regulatory agencies frequently require a Ganciclovir WC (written confirmation) as part of the regulatory process.
click here to find a list of Ganciclovir 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 Ganciclovir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ganciclovir 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 Ganciclovir 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 Ganciclovir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ganciclovir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ganciclovir suppliers with NDC on PharmaCompass.
Ganciclovir 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 Ganciclovir 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 Ganciclovir GMP manufacturer or Ganciclovir GMP API supplier for your needs.
A Ganciclovir CoA (Certificate of Analysis) is a formal document that attests to Ganciclovir's compliance with Ganciclovir specifications and serves as a tool for batch-level quality control.
Ganciclovir CoA mostly includes findings from lab analyses of a specific batch. For each Ganciclovir 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.
Ganciclovir may be tested according to a variety of international standards, such as European Pharmacopoeia (Ganciclovir EP), Ganciclovir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ganciclovir USP).
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