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