X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
0
EU WC
0
Listed Suppliers
0
USA (Orange Book)
Europe
0
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
68
PharmaCompass offers a list of Norgestimate 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 Norgestimate manufacturer or Norgestimate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Norgestimate manufacturer or Norgestimate supplier.
PharmaCompass also assists you with knowing the Norgestimate API Price utilized in the formulation of products. Norgestimate API Price is not always fixed or binding as the Norgestimate Price is obtained through a variety of data sources. The Norgestimate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dexnorgestrel acetime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dexnorgestrel acetime, including repackagers and relabelers. The FDA regulates Dexnorgestrel acetime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dexnorgestrel acetime 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 Dexnorgestrel acetime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dexnorgestrel acetime supplier is an individual or a company that provides Dexnorgestrel acetime active pharmaceutical ingredient (API) or Dexnorgestrel acetime finished formulations upon request. The Dexnorgestrel acetime suppliers may include Dexnorgestrel acetime API manufacturers, exporters, distributors and traders.
click here to find a list of Dexnorgestrel acetime suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dexnorgestrel acetime DMF (Drug Master File) is a document detailing the whole manufacturing process of Dexnorgestrel acetime active pharmaceutical ingredient (API) in detail. Different forms of Dexnorgestrel acetime DMFs exist exist since differing nations have different regulations, such as Dexnorgestrel acetime USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dexnorgestrel acetime DMF submitted to regulatory agencies in the US is known as a USDMF. Dexnorgestrel acetime USDMF includes data on Dexnorgestrel acetime's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dexnorgestrel acetime USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dexnorgestrel acetime suppliers with USDMF on PharmaCompass.
A Dexnorgestrel acetime CEP of the European Pharmacopoeia monograph is often referred to as a Dexnorgestrel acetime Certificate of Suitability (COS). The purpose of a Dexnorgestrel acetime CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dexnorgestrel acetime EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dexnorgestrel acetime to their clients by showing that a Dexnorgestrel acetime CEP has been issued for it. The manufacturer submits a Dexnorgestrel acetime CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dexnorgestrel acetime CEP holder for the record. Additionally, the data presented in the Dexnorgestrel acetime CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dexnorgestrel acetime DMF.
A Dexnorgestrel acetime CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dexnorgestrel acetime 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 Dexnorgestrel acetime 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 Dexnorgestrel acetime as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dexnorgestrel acetime 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 Dexnorgestrel acetime 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 Dexnorgestrel acetime and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dexnorgestrel acetime NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dexnorgestrel acetime suppliers with NDC on PharmaCompass.
Dexnorgestrel acetime 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 Dexnorgestrel acetime 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 Dexnorgestrel acetime GMP manufacturer or Dexnorgestrel acetime GMP API supplier for your needs.
A Dexnorgestrel acetime CoA (Certificate of Analysis) is a formal document that attests to Dexnorgestrel acetime's compliance with Dexnorgestrel acetime specifications and serves as a tool for batch-level quality control.
Dexnorgestrel acetime CoA mostly includes findings from lab analyses of a specific batch. For each Dexnorgestrel acetime 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.
Dexnorgestrel acetime may be tested according to a variety of international standards, such as European Pharmacopoeia (Dexnorgestrel acetime EP), Dexnorgestrel acetime JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dexnorgestrel acetime USP).
Market Place
