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PharmaCompass offers a list of Monosodium Phosphate 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 Monosodium Phosphate manufacturer or Monosodium Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Monosodium Phosphate manufacturer or Monosodium Phosphate supplier.
PharmaCompass also assists you with knowing the Monosodium Phosphate API Price utilized in the formulation of products. Monosodium Phosphate API Price is not always fixed or binding as the Monosodium Phosphate Price is obtained through a variety of data sources. The Monosodium Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 04269_SIAL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 04269_SIAL, including repackagers and relabelers. The FDA regulates 04269_SIAL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 04269_SIAL 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 04269_SIAL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 04269_SIAL supplier is an individual or a company that provides 04269_SIAL active pharmaceutical ingredient (API) or 04269_SIAL finished formulations upon request. The 04269_SIAL suppliers may include 04269_SIAL API manufacturers, exporters, distributors and traders.
click here to find a list of 04269_SIAL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 04269_SIAL DMF (Drug Master File) is a document detailing the whole manufacturing process of 04269_SIAL active pharmaceutical ingredient (API) in detail. Different forms of 04269_SIAL DMFs exist exist since differing nations have different regulations, such as 04269_SIAL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 04269_SIAL DMF submitted to regulatory agencies in the US is known as a USDMF. 04269_SIAL USDMF includes data on 04269_SIAL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 04269_SIAL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 04269_SIAL 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 04269_SIAL Drug Master File in Japan (04269_SIAL JDMF) empowers 04269_SIAL 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 04269_SIAL JDMF during the approval evaluation for pharmaceutical products. At the time of 04269_SIAL 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 04269_SIAL suppliers with JDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing 04269_SIAL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 04269_SIAL API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture 04269_SIAL as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain 04269_SIAL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 04269_SIAL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 04269_SIAL suppliers with NDC on PharmaCompass.
04269_SIAL 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 04269_SIAL 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 04269_SIAL GMP manufacturer or 04269_SIAL GMP API supplier for your needs.
A 04269_SIAL CoA (Certificate of Analysis) is a formal document that attests to 04269_SIAL's compliance with 04269_SIAL specifications and serves as a tool for batch-level quality control.
04269_SIAL CoA mostly includes findings from lab analyses of a specific batch. For each 04269_SIAL 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.
04269_SIAL may be tested according to a variety of international standards, such as European Pharmacopoeia (04269_SIAL EP), 04269_SIAL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (04269_SIAL USP).
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