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API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE;ORAL - EQ 200MG BASE
USFDA APPLICATION NUMBER - 17604
DOSAGE - CAPSULE;ORAL - EQ 400MG BASE
USFDA APPLICATION NUMBER - 17604
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SPI Pharma
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
30
PharmaCompass offers a list of Fenoprofen Calcium 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 Fenoprofen Calcium manufacturer or Fenoprofen Calcium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fenoprofen Calcium manufacturer or Fenoprofen Calcium supplier.
PharmaCompass also assists you with knowing the Fenoprofen Calcium API Price utilized in the formulation of products. Fenoprofen Calcium API Price is not always fixed or binding as the Fenoprofen Calcium Price is obtained through a variety of data sources. The Fenoprofen Calcium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fenoprofen Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenoprofen Calcium, including repackagers and relabelers. The FDA regulates Fenoprofen Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenoprofen Calcium 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 Fenoprofen Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fenoprofen Calcium supplier is an individual or a company that provides Fenoprofen Calcium active pharmaceutical ingredient (API) or Fenoprofen Calcium finished formulations upon request. The Fenoprofen Calcium suppliers may include Fenoprofen Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Fenoprofen Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fenoprofen Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Fenoprofen Calcium active pharmaceutical ingredient (API) in detail. Different forms of Fenoprofen Calcium DMFs exist exist since differing nations have different regulations, such as Fenoprofen Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fenoprofen Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Fenoprofen Calcium USDMF includes data on Fenoprofen Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fenoprofen Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fenoprofen Calcium suppliers with USDMF on PharmaCompass.
A Fenoprofen Calcium written confirmation (Fenoprofen Calcium WC) is an official document issued by a regulatory agency to a Fenoprofen Calcium manufacturer, verifying that the manufacturing facility of a Fenoprofen Calcium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fenoprofen Calcium APIs or Fenoprofen Calcium finished pharmaceutical products to another nation, regulatory agencies frequently require a Fenoprofen Calcium WC (written confirmation) as part of the regulatory process.
click here to find a list of Fenoprofen Calcium 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 Fenoprofen Calcium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fenoprofen Calcium 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 Fenoprofen Calcium 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 Fenoprofen Calcium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fenoprofen Calcium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fenoprofen Calcium suppliers with NDC on PharmaCompass.
Fenoprofen Calcium 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 Fenoprofen Calcium 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 Fenoprofen Calcium GMP manufacturer or Fenoprofen Calcium GMP API supplier for your needs.
A Fenoprofen Calcium CoA (Certificate of Analysis) is a formal document that attests to Fenoprofen Calcium's compliance with Fenoprofen Calcium specifications and serves as a tool for batch-level quality control.
Fenoprofen Calcium CoA mostly includes findings from lab analyses of a specific batch. For each Fenoprofen Calcium 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.
Fenoprofen Calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (Fenoprofen Calcium EP), Fenoprofen Calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fenoprofen Calcium USP).
