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