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