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