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