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PharmaCompass offers a list of Magnesium Sulfate 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 Magnesium Sulfate manufacturer or Magnesium Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Magnesium Sulfate manufacturer or Magnesium Sulfate supplier.
PharmaCompass also assists you with knowing the Magnesium Sulfate API Price utilized in the formulation of products. Magnesium Sulfate API Price is not always fixed or binding as the Magnesium Sulfate Price is obtained through a variety of data sources. The Magnesium Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 00627_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 00627_FLUKA, including repackagers and relabelers. The FDA regulates 00627_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 00627_FLUKA 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 00627_FLUKA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 00627_FLUKA supplier is an individual or a company that provides 00627_FLUKA active pharmaceutical ingredient (API) or 00627_FLUKA finished formulations upon request. The 00627_FLUKA suppliers may include 00627_FLUKA API manufacturers, exporters, distributors and traders.
click here to find a list of 00627_FLUKA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 00627_FLUKA DMF (Drug Master File) is a document detailing the whole manufacturing process of 00627_FLUKA active pharmaceutical ingredient (API) in detail. Different forms of 00627_FLUKA DMFs exist exist since differing nations have different regulations, such as 00627_FLUKA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 00627_FLUKA DMF submitted to regulatory agencies in the US is known as a USDMF. 00627_FLUKA USDMF includes data on 00627_FLUKA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 00627_FLUKA USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 00627_FLUKA Drug Master File in Japan (00627_FLUKA JDMF) empowers 00627_FLUKA 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 00627_FLUKA JDMF during the approval evaluation for pharmaceutical products. At the time of 00627_FLUKA JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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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 00627_FLUKA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 00627_FLUKA 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 00627_FLUKA 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 00627_FLUKA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 00627_FLUKA NDC to their finished compounded human drug products, they may choose to do so.
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00627_FLUKA 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 00627_FLUKA 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 00627_FLUKA GMP manufacturer or 00627_FLUKA GMP API supplier for your needs.
A 00627_FLUKA CoA (Certificate of Analysis) is a formal document that attests to 00627_FLUKA's compliance with 00627_FLUKA specifications and serves as a tool for batch-level quality control.
00627_FLUKA CoA mostly includes findings from lab analyses of a specific batch. For each 00627_FLUKA 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.
00627_FLUKA may be tested according to a variety of international standards, such as European Pharmacopoeia (00627_FLUKA EP), 00627_FLUKA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (00627_FLUKA USP).
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