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