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