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PharmaCompass offers a list of Calcium Stearate API 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 Calcium Stearate API manufacturer or Calcium Stearate API supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Calcium Stearate API manufacturer or Calcium Stearate API supplier.
PharmaCompass also assists you with knowing the Calcium Stearate API API Price utilized in the formulation of products. Calcium Stearate API API Price is not always fixed or binding as the Calcium Stearate API Price is obtained through a variety of data sources. The Calcium Stearate API Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A sodium stearate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of sodium stearate, including repackagers and relabelers. The FDA regulates sodium stearate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. sodium stearate 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 stearate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A sodium stearate supplier is an individual or a company that provides sodium stearate active pharmaceutical ingredient (API) or sodium stearate finished formulations upon request. The sodium stearate suppliers may include sodium stearate API manufacturers, exporters, distributors and traders.
click here to find a list of sodium stearate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A sodium stearate DMF (Drug Master File) is a document detailing the whole manufacturing process of sodium stearate active pharmaceutical ingredient (API) in detail. Different forms of sodium stearate DMFs exist exist since differing nations have different regulations, such as sodium stearate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A sodium stearate DMF submitted to regulatory agencies in the US is known as a USDMF. sodium stearate USDMF includes data on sodium stearate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The sodium stearate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of sodium stearate suppliers with USDMF on PharmaCompass.
A sodium stearate CEP of the European Pharmacopoeia monograph is often referred to as a sodium stearate Certificate of Suitability (COS). The purpose of a sodium stearate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of sodium stearate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of sodium stearate to their clients by showing that a sodium stearate CEP has been issued for it. The manufacturer submits a sodium stearate CEP (COS) as part of the market authorization procedure, and it takes on the role of a sodium stearate CEP holder for the record. Additionally, the data presented in the sodium stearate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the sodium stearate DMF.
A sodium stearate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. sodium stearate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of sodium stearate suppliers with CEP (COS) on PharmaCompass.
sodium stearate 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 stearate 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 stearate GMP manufacturer or sodium stearate GMP API supplier for your needs.
A sodium stearate CoA (Certificate of Analysis) is a formal document that attests to sodium stearate's compliance with sodium stearate specifications and serves as a tool for batch-level quality control.
sodium stearate CoA mostly includes findings from lab analyses of a specific batch. For each sodium stearate 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 stearate may be tested according to a variety of international standards, such as European Pharmacopoeia (sodium stearate EP), sodium stearate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (sodium stearate USP).
