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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Evonik
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REF. STANDARDS & IMPURITIES
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ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
37
PharmaCompass offers a list of Ketoprofen API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ketoprofen manufacturer or Ketoprofen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ketoprofen manufacturer or Ketoprofen supplier.
A Orudis KT manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orudis KT, including repackagers and relabelers. The FDA regulates Orudis KT manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orudis KT 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 Orudis KT manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Orudis KT supplier is an individual or a company that provides Orudis KT active pharmaceutical ingredient (API) or Orudis KT finished formulations upon request. The Orudis KT suppliers may include Orudis KT API manufacturers, exporters, distributors and traders.
click here to find a list of Orudis KT suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Orudis KT DMF (Drug Master File) is a document detailing the whole manufacturing process of Orudis KT active pharmaceutical ingredient (API) in detail. Different forms of Orudis KT DMFs exist exist since differing nations have different regulations, such as Orudis KT USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Orudis KT DMF submitted to regulatory agencies in the US is known as a USDMF. Orudis KT USDMF includes data on Orudis KT's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Orudis KT USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Orudis KT suppliers with USDMF 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 Orudis KT Drug Master File in Japan (Orudis KT JDMF) empowers Orudis KT 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 Orudis KT JDMF during the approval evaluation for pharmaceutical products. At the time of Orudis KT 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 Orudis KT suppliers with JDMF 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 Orudis KT Drug Master File in Korea (Orudis KT KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Orudis KT. The MFDS reviews the Orudis KT KDMF as part of the drug registration process and uses the information provided in the Orudis KT KDMF to evaluate the safety and efficacy of the drug.
After submitting a Orudis KT 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 Orudis KT API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Orudis KT suppliers with KDMF on PharmaCompass.
A Orudis KT CEP of the European Pharmacopoeia monograph is often referred to as a Orudis KT Certificate of Suitability (COS). The purpose of a Orudis KT CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Orudis KT EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Orudis KT to their clients by showing that a Orudis KT CEP has been issued for it. The manufacturer submits a Orudis KT CEP (COS) as part of the market authorization procedure, and it takes on the role of a Orudis KT CEP holder for the record. Additionally, the data presented in the Orudis KT CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Orudis KT DMF.
A Orudis KT CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Orudis KT 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 Orudis KT suppliers with CEP (COS) on PharmaCompass.
A Orudis KT written confirmation (Orudis KT WC) is an official document issued by a regulatory agency to a Orudis KT manufacturer, verifying that the manufacturing facility of a Orudis KT active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Orudis KT APIs or Orudis KT finished pharmaceutical products to another nation, regulatory agencies frequently require a Orudis KT WC (written confirmation) as part of the regulatory process.
click here to find a list of Orudis KT 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 Orudis KT as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Orudis KT 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 Orudis KT 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 Orudis KT and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Orudis KT NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Orudis KT suppliers with NDC on PharmaCompass.
Orudis KT 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 Orudis KT GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Orudis KT GMP manufacturer or Orudis KT GMP API supplier for your needs.
A Orudis KT CoA (Certificate of Analysis) is a formal document that attests to Orudis KT's compliance with Orudis KT specifications and serves as a tool for batch-level quality control.
Orudis KT CoA mostly includes findings from lab analyses of a specific batch. For each Orudis KT 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.
Orudis KT may be tested according to a variety of international standards, such as European Pharmacopoeia (Orudis KT EP), Orudis KT JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Orudis KT USP).
