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DOSAGE - CAPSULE;ORAL - EQ 200MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17604
DOSAGE - CAPSULE;ORAL - EQ 400MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 17604
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ABOUT THIS PAGE
28
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 Calcium fenoprofen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium fenoprofen, including repackagers and relabelers. The FDA regulates Calcium fenoprofen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium fenoprofen 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 Calcium fenoprofen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium fenoprofen supplier is an individual or a company that provides Calcium fenoprofen active pharmaceutical ingredient (API) or Calcium fenoprofen finished formulations upon request. The Calcium fenoprofen suppliers may include Calcium fenoprofen API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium fenoprofen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium fenoprofen DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcium fenoprofen active pharmaceutical ingredient (API) in detail. Different forms of Calcium fenoprofen DMFs exist exist since differing nations have different regulations, such as Calcium fenoprofen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcium fenoprofen DMF submitted to regulatory agencies in the US is known as a USDMF. Calcium fenoprofen USDMF includes data on Calcium fenoprofen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcium fenoprofen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calcium fenoprofen suppliers with USDMF on PharmaCompass.
A Calcium fenoprofen written confirmation (Calcium fenoprofen WC) is an official document issued by a regulatory agency to a Calcium fenoprofen manufacturer, verifying that the manufacturing facility of a Calcium fenoprofen active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Calcium fenoprofen APIs or Calcium fenoprofen finished pharmaceutical products to another nation, regulatory agencies frequently require a Calcium fenoprofen WC (written confirmation) as part of the regulatory process.
click here to find a list of Calcium fenoprofen 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 Calcium fenoprofen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Calcium fenoprofen 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 Calcium fenoprofen 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 Calcium fenoprofen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcium fenoprofen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Calcium fenoprofen suppliers with NDC on PharmaCompass.
Calcium fenoprofen 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 Calcium fenoprofen 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 Calcium fenoprofen GMP manufacturer or Calcium fenoprofen GMP API supplier for your needs.
A Calcium fenoprofen CoA (Certificate of Analysis) is a formal document that attests to Calcium fenoprofen's compliance with Calcium fenoprofen specifications and serves as a tool for batch-level quality control.
Calcium fenoprofen CoA mostly includes findings from lab analyses of a specific batch. For each Calcium fenoprofen 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.
Calcium fenoprofen may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcium fenoprofen EP), Calcium fenoprofen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcium fenoprofen USP).
