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