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API SUPPLIERS
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USDMF
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Anlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.
About the Company : Anlon Healthcare is a research-focused pharmaceutical manufacturer based in Rajkot, specializing in bulk drugs and intermediates. The company’s products comply with international...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products with a focus on rapid development and cost-effective production. Its fully equipped research labs, pilot...
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PharmaCompass offers a list of Loxoprofen Sodium 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 Loxoprofen Sodium manufacturer or Loxoprofen Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Loxoprofen Sodium manufacturer or Loxoprofen Sodium supplier.
A Oxeno manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxeno, including repackagers and relabelers. The FDA regulates Oxeno manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxeno 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 Oxeno manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Oxeno supplier is an individual or a company that provides Oxeno active pharmaceutical ingredient (API) or Oxeno finished formulations upon request. The Oxeno suppliers may include Oxeno API manufacturers, exporters, distributors and traders.
click here to find a list of Oxeno suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Oxeno DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxeno active pharmaceutical ingredient (API) in detail. Different forms of Oxeno DMFs exist exist since differing nations have different regulations, such as Oxeno USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxeno DMF submitted to regulatory agencies in the US is known as a USDMF. Oxeno USDMF includes data on Oxeno's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxeno USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxeno 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 Oxeno Drug Master File in Japan (Oxeno JDMF) empowers Oxeno 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 Oxeno JDMF during the approval evaluation for pharmaceutical products. At the time of Oxeno 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 Oxeno 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 Oxeno Drug Master File in Korea (Oxeno KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oxeno. The MFDS reviews the Oxeno KDMF as part of the drug registration process and uses the information provided in the Oxeno KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oxeno 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 Oxeno API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oxeno suppliers with KDMF on PharmaCompass.
A Oxeno written confirmation (Oxeno WC) is an official document issued by a regulatory agency to a Oxeno manufacturer, verifying that the manufacturing facility of a Oxeno active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxeno APIs or Oxeno finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxeno WC (written confirmation) as part of the regulatory process.
click here to find a list of Oxeno 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 Oxeno as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxeno 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 Oxeno 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 Oxeno and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxeno NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxeno suppliers with NDC on PharmaCompass.
Oxeno 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 Oxeno GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Oxeno GMP manufacturer or Oxeno GMP API supplier for your needs.
A Oxeno CoA (Certificate of Analysis) is a formal document that attests to Oxeno's compliance with Oxeno specifications and serves as a tool for batch-level quality control.
Oxeno CoA mostly includes findings from lab analyses of a specific batch. For each Oxeno 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.
Oxeno may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxeno EP), Oxeno JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxeno USP).
