Synopsis
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
FDF
0
FDA Orange Book
0
Canada
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Gestodene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gestodene, including repackagers and relabelers. The FDA regulates Gestodene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gestodene 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 Gestodene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gestodene supplier is an individual or a company that provides Gestodene active pharmaceutical ingredient (API) or Gestodene finished formulations upon request. The Gestodene suppliers may include Gestodene API manufacturers, exporters, distributors and traders.
click here to find a list of Gestodene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gestodene DMF (Drug Master File) is a document detailing the whole manufacturing process of Gestodene active pharmaceutical ingredient (API) in detail. Different forms of Gestodene DMFs exist exist since differing nations have different regulations, such as Gestodene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gestodene DMF submitted to regulatory agencies in the US is known as a USDMF. Gestodene USDMF includes data on Gestodene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gestodene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gestodene suppliers with USDMF on PharmaCompass.
A Gestodene CEP of the European Pharmacopoeia monograph is often referred to as a Gestodene Certificate of Suitability (COS). The purpose of a Gestodene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gestodene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gestodene to their clients by showing that a Gestodene CEP has been issued for it. The manufacturer submits a Gestodene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gestodene CEP holder for the record. Additionally, the data presented in the Gestodene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gestodene DMF.
A Gestodene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gestodene 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 Gestodene 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 Gestodene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gestodene 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 Gestodene 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 Gestodene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gestodene NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gestodene suppliers with NDC on PharmaCompass.
Gestodene 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 Gestodene 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 Gestodene GMP manufacturer or Gestodene GMP API supplier for your needs.
A Gestodene CoA (Certificate of Analysis) is a formal document that attests to Gestodene's compliance with Gestodene specifications and serves as a tool for batch-level quality control.
Gestodene CoA mostly includes findings from lab analyses of a specific batch. For each Gestodene 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.
Gestodene may be tested according to a variety of international standards, such as European Pharmacopoeia (Gestodene EP), Gestodene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gestodene USP).
LOOKING FOR A SUPPLIER?
