US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Gemcitabine 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 Gemcitabine manufacturer or Gemcitabine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gemcitabine manufacturer or Gemcitabine supplier.
PharmaCompass also assists you with knowing the Gemcitabine API Price utilized in the formulation of products. Gemcitabine API Price is not always fixed or binding as the Gemcitabine Price is obtained through a variety of data sources. The Gemcitabine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gemcitabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gemcitabine, including repackagers and relabelers. The FDA regulates Gemcitabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gemcitabine 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 Gemcitabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gemcitabine supplier is an individual or a company that provides Gemcitabine active pharmaceutical ingredient (API) or Gemcitabine finished formulations upon request. The Gemcitabine suppliers may include Gemcitabine API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Gemcitabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gemcitabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Gemcitabine active pharmaceutical ingredient (API) in detail. Different forms of Gemcitabine DMFs exist exist since differing nations have different regulations, such as Gemcitabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gemcitabine DMF submitted to regulatory agencies in the US is known as a USDMF. Gemcitabine USDMF includes data on Gemcitabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gemcitabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Gemcitabine Drug Master File in Japan (Gemcitabine JDMF) empowers Gemcitabine 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 Gemcitabine JDMF during the approval evaluation for pharmaceutical products. At the time of Gemcitabine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Gemcitabine Drug Master File in Korea (Gemcitabine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gemcitabine. The MFDS reviews the Gemcitabine KDMF as part of the drug registration process and uses the information provided in the Gemcitabine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gemcitabine 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 Gemcitabine API can apply through the Korea Drug Master File (KDMF).
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A Gemcitabine CEP of the European Pharmacopoeia monograph is often referred to as a Gemcitabine Certificate of Suitability (COS). The purpose of a Gemcitabine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gemcitabine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gemcitabine to their clients by showing that a Gemcitabine CEP has been issued for it. The manufacturer submits a Gemcitabine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gemcitabine CEP holder for the record. Additionally, the data presented in the Gemcitabine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gemcitabine DMF.
A Gemcitabine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gemcitabine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Gemcitabine written confirmation (Gemcitabine WC) is an official document issued by a regulatory agency to a Gemcitabine manufacturer, verifying that the manufacturing facility of a Gemcitabine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gemcitabine APIs or Gemcitabine finished pharmaceutical products to another nation, regulatory agencies frequently require a Gemcitabine 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 Gemcitabine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gemcitabine 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 Gemcitabine 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 Gemcitabine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gemcitabine NDC to their finished compounded human drug products, they may choose to do so.
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Gemcitabine 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 Gemcitabine 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 Gemcitabine GMP manufacturer or Gemcitabine GMP API supplier for your needs.
A Gemcitabine CoA (Certificate of Analysis) is a formal document that attests to Gemcitabine's compliance with Gemcitabine specifications and serves as a tool for batch-level quality control.
Gemcitabine CoA mostly includes findings from lab analyses of a specific batch. For each Gemcitabine 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.
Gemcitabine may be tested according to a variety of international standards, such as European Pharmacopoeia (Gemcitabine EP), Gemcitabine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gemcitabine USP).