US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Acyclovir Sodium 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 Acyclovir Sodium manufacturer or Acyclovir Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acyclovir Sodium manufacturer or Acyclovir Sodium supplier.
PharmaCompass also assists you with knowing the Acyclovir Sodium API Price utilized in the formulation of products. Acyclovir Sodium API Price is not always fixed or binding as the Acyclovir Sodium Price is obtained through a variety of data sources. The Acyclovir Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Acyclovir Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acyclovir Sodium, including repackagers and relabelers. The FDA regulates Acyclovir Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acyclovir 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.
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A Acyclovir Sodium supplier is an individual or a company that provides Acyclovir Sodium active pharmaceutical ingredient (API) or Acyclovir Sodium finished formulations upon request. The Acyclovir Sodium suppliers may include Acyclovir Sodium API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Acyclovir Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acyclovir Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Acyclovir Sodium active pharmaceutical ingredient (API) in detail. Different forms of Acyclovir Sodium DMFs exist exist since differing nations have different regulations, such as Acyclovir Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acyclovir Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Acyclovir Sodium USDMF includes data on Acyclovir Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acyclovir Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
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A Acyclovir Sodium written confirmation (Acyclovir Sodium WC) is an official document issued by a regulatory agency to a Acyclovir Sodium manufacturer, verifying that the manufacturing facility of a Acyclovir Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acyclovir Sodium APIs or Acyclovir Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Acyclovir Sodium WC (written confirmation) as part of the regulatory process.
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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 Acyclovir Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acyclovir 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 Acyclovir 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 Acyclovir Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acyclovir Sodium NDC to their finished compounded human drug products, they may choose to do so.
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Acyclovir 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 Acyclovir 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 Acyclovir Sodium GMP manufacturer or Acyclovir Sodium GMP API supplier for your needs.
A Acyclovir Sodium CoA (Certificate of Analysis) is a formal document that attests to Acyclovir Sodium's compliance with Acyclovir Sodium specifications and serves as a tool for batch-level quality control.
Acyclovir Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Acyclovir 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.
Acyclovir Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Acyclovir Sodium EP), Acyclovir Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acyclovir Sodium USP).