X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
43
PharmaCompass offers a list of Norethisterone 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 manufacturer or Norethisterone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Norethisterone manufacturer or Norethisterone supplier.
PharmaCompass also assists you with knowing the Norethisterone API Price utilized in the formulation of products. Norethisterone API Price is not always fixed or binding as the Norethisterone Price is obtained through a variety of data sources. The Norethisterone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Norethindrone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norethindrone, including repackagers and relabelers. The FDA regulates Norethindrone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norethindrone 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 Norethindrone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Norethindrone supplier is an individual or a company that provides Norethindrone active pharmaceutical ingredient (API) or Norethindrone finished formulations upon request. The Norethindrone suppliers may include Norethindrone API manufacturers, exporters, distributors and traders.
click here to find a list of Norethindrone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Norethindrone DMF (Drug Master File) is a document detailing the whole manufacturing process of Norethindrone active pharmaceutical ingredient (API) in detail. Different forms of Norethindrone DMFs exist exist since differing nations have different regulations, such as Norethindrone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Norethindrone DMF submitted to regulatory agencies in the US is known as a USDMF. Norethindrone USDMF includes data on Norethindrone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Norethindrone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Norethindrone suppliers with USDMF on PharmaCompass.
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 Norethindrone Drug Master File in Japan (Norethindrone JDMF) empowers Norethindrone 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 Norethindrone JDMF during the approval evaluation for pharmaceutical products. At the time of Norethindrone JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Norethindrone suppliers with JDMF on PharmaCompass.
A Norethindrone CEP of the European Pharmacopoeia monograph is often referred to as a Norethindrone Certificate of Suitability (COS). The purpose of a Norethindrone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Norethindrone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Norethindrone to their clients by showing that a Norethindrone CEP has been issued for it. The manufacturer submits a Norethindrone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Norethindrone CEP holder for the record. Additionally, the data presented in the Norethindrone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Norethindrone DMF.
A Norethindrone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Norethindrone 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 Norethindrone suppliers with CEP (COS) on PharmaCompass.
A Norethindrone written confirmation (Norethindrone WC) is an official document issued by a regulatory agency to a Norethindrone manufacturer, verifying that the manufacturing facility of a Norethindrone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Norethindrone APIs or Norethindrone finished pharmaceutical products to another nation, regulatory agencies frequently require a Norethindrone WC (written confirmation) as part of the regulatory process.
click here to find a list of Norethindrone 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 Norethindrone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Norethindrone 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 Norethindrone 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 Norethindrone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Norethindrone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Norethindrone suppliers with NDC on PharmaCompass.
Norethindrone 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 Norethindrone 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 Norethindrone GMP manufacturer or Norethindrone GMP API supplier for your needs.
A Norethindrone CoA (Certificate of Analysis) is a formal document that attests to Norethindrone's compliance with Norethindrone specifications and serves as a tool for batch-level quality control.
Norethindrone CoA mostly includes findings from lab analyses of a specific batch. For each Norethindrone 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.
Norethindrone may be tested according to a variety of international standards, such as European Pharmacopoeia (Norethindrone EP), Norethindrone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Norethindrone USP).
Market Place
