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PharmaCompass offers a list of 2-Methoxyestradiol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right 2-Methoxyestradiol manufacturer or 2-Methoxyestradiol supplier for your needs.
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A 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether, including repackagers and relabelers. The FDA regulates 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether 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 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether supplier is an individual or a company that provides 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether active pharmaceutical ingredient (API) or 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether finished formulations upon request. The 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether suppliers may include 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether API manufacturers, exporters, distributors and traders.
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A 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether DMF (Drug Master File) is a document detailing the whole manufacturing process of 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether active pharmaceutical ingredient (API) in detail. Different forms of 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether DMFs exist exist since differing nations have different regulations, such as 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether DMF submitted to regulatory agencies in the US is known as a USDMF. 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether USDMF includes data on 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether 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 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether 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 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether NDC to their finished compounded human drug products, they may choose to do so.
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1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether 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 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether 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 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether GMP manufacturer or 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether GMP API supplier for your needs.
A 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether CoA (Certificate of Analysis) is a formal document that attests to 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether's compliance with 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether specifications and serves as a tool for batch-level quality control.
1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether CoA mostly includes findings from lab analyses of a specific batch. For each 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether 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.
1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether may be tested according to a variety of international standards, such as European Pharmacopoeia (1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether EP), 1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1,3,5(10)-Estratriene-2,3,17-triol 2-methyl ether USP).