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PharmaCompass offers a list of ubenimex 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 ubenimex manufacturer or ubenimex supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred ubenimex manufacturer or ubenimex supplier.
PharmaCompass also assists you with knowing the ubenimex API Price utilized in the formulation of products. ubenimex API Price is not always fixed or binding as the ubenimex Price is obtained through a variety of data sources. The ubenimex Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ubenimex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ubenimex, including repackagers and relabelers. The FDA regulates ubenimex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ubenimex 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 ubenimex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ubenimex supplier is an individual or a company that provides ubenimex active pharmaceutical ingredient (API) or ubenimex finished formulations upon request. The ubenimex suppliers may include ubenimex API manufacturers, exporters, distributors and traders.
click here to find a list of ubenimex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ubenimex DMF (Drug Master File) is a document detailing the whole manufacturing process of ubenimex active pharmaceutical ingredient (API) in detail. Different forms of ubenimex DMFs exist exist since differing nations have different regulations, such as ubenimex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ubenimex DMF submitted to regulatory agencies in the US is known as a USDMF. ubenimex USDMF includes data on ubenimex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ubenimex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ubenimex 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 ubenimex Drug Master File in Japan (ubenimex JDMF) empowers ubenimex 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 ubenimex JDMF during the approval evaluation for pharmaceutical products. At the time of ubenimex 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 ubenimex suppliers with JDMF on PharmaCompass.
ubenimex 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 ubenimex 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 ubenimex GMP manufacturer or ubenimex GMP API supplier for your needs.
A ubenimex CoA (Certificate of Analysis) is a formal document that attests to ubenimex's compliance with ubenimex specifications and serves as a tool for batch-level quality control.
ubenimex CoA mostly includes findings from lab analyses of a specific batch. For each ubenimex 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.
ubenimex may be tested according to a variety of international standards, such as European Pharmacopoeia (ubenimex EP), ubenimex JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ubenimex USP).
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