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ABOUT THIS PAGE
A Diethylstilbestrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diethylstilbestrol, including repackagers and relabelers. The FDA regulates Diethylstilbestrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diethylstilbestrol 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 Diethylstilbestrol supplier is an individual or a company that provides Diethylstilbestrol active pharmaceutical ingredient (API) or Diethylstilbestrol finished formulations upon request. The Diethylstilbestrol suppliers may include Diethylstilbestrol API manufacturers, exporters, distributors and traders.
click here to find a list of Diethylstilbestrol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diethylstilbestrol DMF (Drug Master File) is a document detailing the whole manufacturing process of Diethylstilbestrol active pharmaceutical ingredient (API) in detail. Different forms of Diethylstilbestrol DMFs exist exist since differing nations have different regulations, such as Diethylstilbestrol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diethylstilbestrol DMF submitted to regulatory agencies in the US is known as a USDMF. Diethylstilbestrol USDMF includes data on Diethylstilbestrol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diethylstilbestrol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diethylstilbestrol suppliers with USDMF on PharmaCompass.
A Diethylstilbestrol CEP of the European Pharmacopoeia monograph is often referred to as a Diethylstilbestrol Certificate of Suitability (COS). The purpose of a Diethylstilbestrol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Diethylstilbestrol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Diethylstilbestrol to their clients by showing that a Diethylstilbestrol CEP has been issued for it. The manufacturer submits a Diethylstilbestrol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Diethylstilbestrol CEP holder for the record. Additionally, the data presented in the Diethylstilbestrol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Diethylstilbestrol DMF.
A Diethylstilbestrol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Diethylstilbestrol 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 Diethylstilbestrol suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Diethylstilbestrol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Diethylstilbestrol API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Diethylstilbestrol as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Diethylstilbestrol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Diethylstilbestrol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Diethylstilbestrol suppliers with NDC on PharmaCompass.
Diethylstilbestrol 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 Diethylstilbestrol 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 Diethylstilbestrol GMP manufacturer or Diethylstilbestrol GMP API supplier for your needs.
A Diethylstilbestrol CoA (Certificate of Analysis) is a formal document that attests to Diethylstilbestrol's compliance with Diethylstilbestrol specifications and serves as a tool for batch-level quality control.
Diethylstilbestrol CoA mostly includes findings from lab analyses of a specific batch. For each Diethylstilbestrol 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.
Diethylstilbestrol may be tested according to a variety of international standards, such as European Pharmacopoeia (Diethylstilbestrol EP), Diethylstilbestrol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Diethylstilbestrol USP).
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