Synopsis
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CEP/COS
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NDC API
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FDA Orange Book
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API SUPPLIERS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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USDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 365
Submission : 1960-03-03
Status :
Type : IV
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DATA COMPILATION #PharmaFlow
ABOUT THIS PAGE
A Emulphor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Emulphor, including repackagers and relabelers. The FDA regulates Emulphor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Emulphor API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Emulphor supplier is an individual or a company that provides Emulphor active pharmaceutical ingredient (API) or Emulphor finished formulations upon request. The Emulphor suppliers may include Emulphor API manufacturers, exporters, distributors and traders.
click here to find a list of Emulphor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Emulphor DMF (Drug Master File) is a document detailing the whole manufacturing process of Emulphor active pharmaceutical ingredient (API) in detail. Different forms of Emulphor DMFs exist exist since differing nations have different regulations, such as Emulphor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Emulphor DMF submitted to regulatory agencies in the US is known as a USDMF. Emulphor USDMF includes data on Emulphor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Emulphor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Emulphor suppliers with USDMF on PharmaCompass.
Emulphor 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 Emulphor 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 Emulphor GMP manufacturer or Emulphor GMP API supplier for your needs.
A Emulphor CoA (Certificate of Analysis) is a formal document that attests to Emulphor's compliance with Emulphor specifications and serves as a tool for batch-level quality control.
Emulphor CoA mostly includes findings from lab analyses of a specific batch. For each Emulphor 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.
Emulphor may be tested according to a variety of international standards, such as European Pharmacopoeia (Emulphor EP), Emulphor JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Emulphor USP).
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