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Faran Shimi Pharmaceutical
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ABOUT THIS PAGE
A Ofatumumab manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ofatumumab, including repackagers and relabelers. The FDA regulates Ofatumumab manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ofatumumab API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Ofatumumab supplier is an individual or a company that provides Ofatumumab active pharmaceutical ingredient (API) or Ofatumumab finished formulations upon request. The Ofatumumab suppliers may include Ofatumumab API manufacturers, exporters, distributors and traders.
click here to find a list of Ofatumumab suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Ofatumumab Drug Master File in Japan (Ofatumumab JDMF) empowers Ofatumumab 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 Ofatumumab JDMF during the approval evaluation for pharmaceutical products. At the time of Ofatumumab 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 Ofatumumab suppliers with JDMF on PharmaCompass.
Ofatumumab 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 Ofatumumab 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 Ofatumumab GMP manufacturer or Ofatumumab GMP API supplier for your needs.
A Ofatumumab CoA (Certificate of Analysis) is a formal document that attests to Ofatumumab's compliance with Ofatumumab specifications and serves as a tool for batch-level quality control.
Ofatumumab CoA mostly includes findings from lab analyses of a specific batch. For each Ofatumumab 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.
Ofatumumab may be tested according to a variety of international standards, such as European Pharmacopoeia (Ofatumumab EP), Ofatumumab JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ofatumumab USP).
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