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PharmaCompass offers a list of Norethisterone Acetate 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 Norethisterone Acetate manufacturer or Norethisterone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Norethisterone Acetate manufacturer or Norethisterone Acetate supplier.
PharmaCompass also assists you with knowing the Norethisterone Acetate API Price utilized in the formulation of products. Norethisterone Acetate API Price is not always fixed or binding as the Norethisterone Acetate Price is obtained through a variety of data sources. The Norethisterone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate, including repackagers and relabelers. The FDA regulates 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate supplier is an individual or a company that provides 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate active pharmaceutical ingredient (API) or 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate finished formulations upon request. The 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate suppliers may include 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate API manufacturers, exporters, distributors and traders.
click here to find a list of 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate active pharmaceutical ingredient (API) in detail. Different forms of 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate DMFs exist exist since differing nations have different regulations, such as 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate DMF submitted to regulatory agencies in the US is known as a USDMF. 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate USDMF includes data on 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate Drug Master File in Japan (17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate JDMF) empowers 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate JDMF during the approval evaluation for pharmaceutical products. At the time of 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate CEP of the European Pharmacopoeia monograph is often referred to as a 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate Certificate of Suitability (COS). The purpose of a 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate to their clients by showing that a 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate CEP has been issued for it. The manufacturer submits a 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate CEP holder for the record. Additionally, the data presented in the 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate DMF.
A 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate written confirmation (17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate WC) is an official document issued by a regulatory agency to a 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate manufacturer, verifying that the manufacturing facility of a 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate APIs or 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate suppliers with Written Confirmation (WC) 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 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate 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 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate 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 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate NDC to their finished compounded human drug products, they may choose to do so.
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17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate 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 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate 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 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate GMP manufacturer or 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate GMP API supplier for your needs.
A 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate CoA (Certificate of Analysis) is a formal document that attests to 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate's compliance with 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate specifications and serves as a tool for batch-level quality control.
17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate CoA mostly includes findings from lab analyses of a specific batch. For each 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate 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.
17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate EP), 17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate USP).