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FDA Orange Book
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API SUPPLIERS
Jai Radhe Sales is your partner for all your sourcing needs.
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USDMF
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Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
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Market Place
REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Magnesium Stearate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Magnesium Stearate API, including repackagers and relabelers. The FDA regulates Magnesium Stearate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Magnesium Stearate API 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 Magnesium Stearate API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Magnesium Stearate API supplier is an individual or a company that provides Magnesium Stearate API active pharmaceutical ingredient (API) or Magnesium Stearate API finished formulations upon request. The Magnesium Stearate API suppliers may include Magnesium Stearate API API manufacturers, exporters, distributors and traders.
click here to find a list of Magnesium Stearate API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Magnesium Stearate API DMF (Drug Master File) is a document detailing the whole manufacturing process of Magnesium Stearate API active pharmaceutical ingredient (API) in detail. Different forms of Magnesium Stearate API DMFs exist exist since differing nations have different regulations, such as Magnesium Stearate API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Magnesium Stearate API DMF submitted to regulatory agencies in the US is known as a USDMF. Magnesium Stearate API USDMF includes data on Magnesium Stearate API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Magnesium Stearate API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Magnesium Stearate API suppliers with USDMF on PharmaCompass.
A Magnesium Stearate API CEP of the European Pharmacopoeia monograph is often referred to as a Magnesium Stearate API Certificate of Suitability (COS). The purpose of a Magnesium Stearate API CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Magnesium Stearate API EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Magnesium Stearate API to their clients by showing that a Magnesium Stearate API CEP has been issued for it. The manufacturer submits a Magnesium Stearate API CEP (COS) as part of the market authorization procedure, and it takes on the role of a Magnesium Stearate API CEP holder for the record. Additionally, the data presented in the Magnesium Stearate API CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Magnesium Stearate API DMF.
A Magnesium Stearate API CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Magnesium Stearate API 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 Magnesium Stearate API suppliers with CEP (COS) on PharmaCompass.
Magnesium Stearate API 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 Magnesium Stearate API 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 Magnesium Stearate API GMP manufacturer or Magnesium Stearate API GMP API supplier for your needs.
A Magnesium Stearate API CoA (Certificate of Analysis) is a formal document that attests to Magnesium Stearate API's compliance with Magnesium Stearate API specifications and serves as a tool for batch-level quality control.
Magnesium Stearate API CoA mostly includes findings from lab analyses of a specific batch. For each Magnesium Stearate API 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.
Magnesium Stearate API may be tested according to a variety of international standards, such as European Pharmacopoeia (Magnesium Stearate API EP), Magnesium Stearate API JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Magnesium Stearate API USP).
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