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