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ABOUT THIS PAGE
A Ganciclovir Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ganciclovir Sodium, including repackagers and relabelers. The FDA regulates Ganciclovir Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ganciclovir Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ganciclovir Sodium supplier is an individual or a company that provides Ganciclovir Sodium active pharmaceutical ingredient (API) or Ganciclovir Sodium finished formulations upon request. The Ganciclovir Sodium suppliers may include Ganciclovir Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Ganciclovir Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ganciclovir Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Ganciclovir Sodium active pharmaceutical ingredient (API) in detail. Different forms of Ganciclovir Sodium DMFs exist exist since differing nations have different regulations, such as Ganciclovir Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ganciclovir Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Ganciclovir Sodium USDMF includes data on Ganciclovir Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ganciclovir Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ganciclovir Sodium suppliers with USDMF 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 Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ganciclovir Sodium 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 Sodium 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 Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ganciclovir Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ganciclovir Sodium suppliers with NDC on PharmaCompass.
Ganciclovir Sodium 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 Sodium 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 Sodium GMP manufacturer or Ganciclovir Sodium GMP API supplier for your needs.
A Ganciclovir Sodium CoA (Certificate of Analysis) is a formal document that attests to Ganciclovir Sodium's compliance with Ganciclovir Sodium specifications and serves as a tool for batch-level quality control.
Ganciclovir Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Ganciclovir Sodium 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 Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Ganciclovir Sodium EP), Ganciclovir Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ganciclovir Sodium USP).
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