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ABOUT THIS PAGE
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PharmaCompass offers a list of Felypressin 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 Felypressin manufacturer or Felypressin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Felypressin manufacturer or Felypressin supplier.
PharmaCompass also assists you with knowing the Felypressin API Price utilized in the formulation of products. Felypressin API Price is not always fixed or binding as the Felypressin Price is obtained through a variety of data sources. The Felypressin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Felipresina manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Felipresina, including repackagers and relabelers. The FDA regulates Felipresina manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Felipresina 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 Felipresina manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Felipresina supplier is an individual or a company that provides Felipresina active pharmaceutical ingredient (API) or Felipresina finished formulations upon request. The Felipresina suppliers may include Felipresina API manufacturers, exporters, distributors and traders.
click here to find a list of Felipresina suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Felipresina Drug Master File in Japan (Felipresina JDMF) empowers Felipresina 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 Felipresina JDMF during the approval evaluation for pharmaceutical products. At the time of Felipresina 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 Felipresina suppliers with JDMF on PharmaCompass.
A Felipresina CEP of the European Pharmacopoeia monograph is often referred to as a Felipresina Certificate of Suitability (COS). The purpose of a Felipresina CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Felipresina EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Felipresina to their clients by showing that a Felipresina CEP has been issued for it. The manufacturer submits a Felipresina CEP (COS) as part of the market authorization procedure, and it takes on the role of a Felipresina CEP holder for the record. Additionally, the data presented in the Felipresina CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Felipresina DMF.
A Felipresina CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Felipresina 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 Felipresina suppliers with CEP (COS) 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 Felipresina as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Felipresina 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 Felipresina 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 Felipresina and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Felipresina NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Felipresina suppliers with NDC on PharmaCompass.
Felipresina 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 Felipresina 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 Felipresina GMP manufacturer or Felipresina GMP API supplier for your needs.
A Felipresina CoA (Certificate of Analysis) is a formal document that attests to Felipresina's compliance with Felipresina specifications and serves as a tool for batch-level quality control.
Felipresina CoA mostly includes findings from lab analyses of a specific batch. For each Felipresina 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.
Felipresina may be tested according to a variety of international standards, such as European Pharmacopoeia (Felipresina EP), Felipresina JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Felipresina USP).
