Synopsis
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CEP/COS
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JDMF
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EU WC
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KDMF
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NDC API
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VMF
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FDF
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FDA Orange Book
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Europe
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Australia
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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EDQM
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USP
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JP
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
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]Listed Suppliers
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ABOUT THIS PAGE
A Calamine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calamine, including repackagers and relabelers. The FDA regulates Calamine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calamine 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 Calamine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calamine supplier is an individual or a company that provides Calamine active pharmaceutical ingredient (API) or Calamine finished formulations upon request. The Calamine suppliers may include Calamine API manufacturers, exporters, distributors and traders.
click here to find a list of Calamine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calamine DMF (Drug Master File) is a document detailing the whole manufacturing process of Calamine active pharmaceutical ingredient (API) in detail. Different forms of Calamine DMFs exist exist since differing nations have different regulations, such as Calamine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calamine DMF submitted to regulatory agencies in the US is known as a USDMF. Calamine USDMF includes data on Calamine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calamine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calamine suppliers with USDMF on PharmaCompass.
Calamine 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 Calamine 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 Calamine GMP manufacturer or Calamine GMP API supplier for your needs.
A Calamine CoA (Certificate of Analysis) is a formal document that attests to Calamine's compliance with Calamine specifications and serves as a tool for batch-level quality control.
Calamine CoA mostly includes findings from lab analyses of a specific batch. For each Calamine 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.
Calamine may be tested according to a variety of international standards, such as European Pharmacopoeia (Calamine EP), Calamine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calamine USP).
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