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