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DOSAGE - TABLET;ORAL-28 - 0.035MG;0.25MG **Fe...DOSAGE - TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19653
DOSAGE - TABLET;ORAL-28 - 0.035MG,0.035MG,0.0...DOSAGE - TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19697
DOSAGE - TABLET;ORAL-28 - 0.025MG,0.025MG,0.0...DOSAGE - TABLET;ORAL-28 - 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21241
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ABOUT THIS PAGE
A Norgestimate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norgestimate, including repackagers and relabelers. The FDA regulates Norgestimate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norgestimate 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 Norgestimate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Norgestimate supplier is an individual or a company that provides Norgestimate active pharmaceutical ingredient (API) or Norgestimate finished formulations upon request. The Norgestimate suppliers may include Norgestimate API manufacturers, exporters, distributors and traders.
click here to find a list of Norgestimate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Norgestimate DMF (Drug Master File) is a document detailing the whole manufacturing process of Norgestimate active pharmaceutical ingredient (API) in detail. Different forms of Norgestimate DMFs exist exist since differing nations have different regulations, such as Norgestimate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Norgestimate DMF submitted to regulatory agencies in the US is known as a USDMF. Norgestimate USDMF includes data on Norgestimate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Norgestimate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Norgestimate suppliers with USDMF on PharmaCompass.
A Norgestimate CEP of the European Pharmacopoeia monograph is often referred to as a Norgestimate Certificate of Suitability (COS). The purpose of a Norgestimate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Norgestimate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Norgestimate to their clients by showing that a Norgestimate CEP has been issued for it. The manufacturer submits a Norgestimate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Norgestimate CEP holder for the record. Additionally, the data presented in the Norgestimate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Norgestimate DMF.
A Norgestimate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Norgestimate 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 Norgestimate 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 Norgestimate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Norgestimate 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 Norgestimate 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 Norgestimate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Norgestimate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Norgestimate suppliers with NDC on PharmaCompass.
Norgestimate 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 Norgestimate 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 Norgestimate GMP manufacturer or Norgestimate GMP API supplier for your needs.
A Norgestimate CoA (Certificate of Analysis) is a formal document that attests to Norgestimate's compliance with Norgestimate specifications and serves as a tool for batch-level quality control.
Norgestimate CoA mostly includes findings from lab analyses of a specific batch. For each Norgestimate 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.
Norgestimate may be tested according to a variety of international standards, such as European Pharmacopoeia (Norgestimate EP), Norgestimate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Norgestimate USP).
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