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