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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]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Listed Suppliers
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REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Catalase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Catalase, including repackagers and relabelers. The FDA regulates Catalase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Catalase 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 Catalase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Catalase supplier is an individual or a company that provides Catalase active pharmaceutical ingredient (API) or Catalase finished formulations upon request. The Catalase suppliers may include Catalase API manufacturers, exporters, distributors and traders.
click here to find a list of Catalase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Catalase DMF (Drug Master File) is a document detailing the whole manufacturing process of Catalase active pharmaceutical ingredient (API) in detail. Different forms of Catalase DMFs exist exist since differing nations have different regulations, such as Catalase USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Catalase DMF submitted to regulatory agencies in the US is known as a USDMF. Catalase USDMF includes data on Catalase's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Catalase USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Catalase suppliers with USDMF on PharmaCompass.
A Catalase CEP of the European Pharmacopoeia monograph is often referred to as a Catalase Certificate of Suitability (COS). The purpose of a Catalase CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Catalase EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Catalase to their clients by showing that a Catalase CEP has been issued for it. The manufacturer submits a Catalase CEP (COS) as part of the market authorization procedure, and it takes on the role of a Catalase CEP holder for the record. Additionally, the data presented in the Catalase CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Catalase DMF.
A Catalase CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Catalase 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 Catalase suppliers with CEP (COS) on PharmaCompass.
Catalase 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 Catalase 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 Catalase GMP manufacturer or Catalase GMP API supplier for your needs.
A Catalase CoA (Certificate of Analysis) is a formal document that attests to Catalase's compliance with Catalase specifications and serves as a tool for batch-level quality control.
Catalase CoA mostly includes findings from lab analyses of a specific batch. For each Catalase 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.
Catalase may be tested according to a variety of international standards, such as European Pharmacopoeia (Catalase EP), Catalase JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Catalase USP).
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