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ABOUT THIS PAGE
A Maxacalcitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maxacalcitol, including repackagers and relabelers. The FDA regulates Maxacalcitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maxacalcitol 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 Maxacalcitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Maxacalcitol supplier is an individual or a company that provides Maxacalcitol active pharmaceutical ingredient (API) or Maxacalcitol finished formulations upon request. The Maxacalcitol suppliers may include Maxacalcitol API manufacturers, exporters, distributors and traders.
click here to find a list of Maxacalcitol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Maxacalcitol DMF (Drug Master File) is a document detailing the whole manufacturing process of Maxacalcitol active pharmaceutical ingredient (API) in detail. Different forms of Maxacalcitol DMFs exist exist since differing nations have different regulations, such as Maxacalcitol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Maxacalcitol DMF submitted to regulatory agencies in the US is known as a USDMF. Maxacalcitol USDMF includes data on Maxacalcitol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Maxacalcitol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Maxacalcitol 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 Maxacalcitol Drug Master File in Japan (Maxacalcitol JDMF) empowers Maxacalcitol 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 Maxacalcitol JDMF during the approval evaluation for pharmaceutical products. At the time of Maxacalcitol 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 Maxacalcitol suppliers with JDMF on PharmaCompass.
Maxacalcitol 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 Maxacalcitol 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 Maxacalcitol GMP manufacturer or Maxacalcitol GMP API supplier for your needs.
A Maxacalcitol CoA (Certificate of Analysis) is a formal document that attests to Maxacalcitol's compliance with Maxacalcitol specifications and serves as a tool for batch-level quality control.
Maxacalcitol CoA mostly includes findings from lab analyses of a specific batch. For each Maxacalcitol 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.
Maxacalcitol may be tested according to a variety of international standards, such as European Pharmacopoeia (Maxacalcitol EP), Maxacalcitol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Maxacalcitol USP).
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