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