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JDMF
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FDF Dossiers
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FDA Orange Book
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USP
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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US Medicaid
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API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Sodium carbonate, monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium carbonate, monohydrate, including repackagers and relabelers. The FDA regulates Sodium carbonate, monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium carbonate, monohydrate 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 Sodium carbonate, monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium carbonate, monohydrate supplier is an individual or a company that provides Sodium carbonate, monohydrate active pharmaceutical ingredient (API) or Sodium carbonate, monohydrate finished formulations upon request. The Sodium carbonate, monohydrate suppliers may include Sodium carbonate, monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium carbonate, monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium carbonate, monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium carbonate, monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Sodium carbonate, monohydrate DMFs exist exist since differing nations have different regulations, such as Sodium carbonate, monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium carbonate, monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium carbonate, monohydrate USDMF includes data on Sodium carbonate, monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium carbonate, monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium carbonate, monohydrate suppliers with USDMF 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 Sodium carbonate, monohydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium carbonate, monohydrate 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 Sodium carbonate, monohydrate 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 Sodium carbonate, monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium carbonate, monohydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium carbonate, monohydrate suppliers with NDC on PharmaCompass.
Sodium carbonate, monohydrate 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 Sodium carbonate, monohydrate 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 Sodium carbonate, monohydrate GMP manufacturer or Sodium carbonate, monohydrate GMP API supplier for your needs.
A Sodium carbonate, monohydrate CoA (Certificate of Analysis) is a formal document that attests to Sodium carbonate, monohydrate's compliance with Sodium carbonate, monohydrate specifications and serves as a tool for batch-level quality control.
Sodium carbonate, monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium carbonate, monohydrate 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.
Sodium carbonate, monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium carbonate, monohydrate EP), Sodium carbonate, monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium carbonate, monohydrate USP).
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