Synopsis
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JDMF
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EU WC
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KDMF
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VMF
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Europe
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Australia
DRUG PRODUCT COMPOSITIONS0
US Patents
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US Exclusivities
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Health Canada Patents
US Medicaid
NA
Annual Reports
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Regulatory FDF Prices
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2364
Submission : 1974-11-26
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14241
Submission : 1999-06-25
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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**Fe...DOSAGE - TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
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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 PREFEST-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PREFEST-1, including repackagers and relabelers. The FDA regulates PREFEST-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PREFEST-1 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 PREFEST-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A PREFEST-1 supplier is an individual or a company that provides PREFEST-1 active pharmaceutical ingredient (API) or PREFEST-1 finished formulations upon request. The PREFEST-1 suppliers may include PREFEST-1 API manufacturers, exporters, distributors and traders.
click here to find a list of PREFEST-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A PREFEST-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of PREFEST-1 active pharmaceutical ingredient (API) in detail. Different forms of PREFEST-1 DMFs exist exist since differing nations have different regulations, such as PREFEST-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A PREFEST-1 DMF submitted to regulatory agencies in the US is known as a USDMF. PREFEST-1 USDMF includes data on PREFEST-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The PREFEST-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of PREFEST-1 suppliers with USDMF on PharmaCompass.
A PREFEST-1 CEP of the European Pharmacopoeia monograph is often referred to as a PREFEST-1 Certificate of Suitability (COS). The purpose of a PREFEST-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of PREFEST-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of PREFEST-1 to their clients by showing that a PREFEST-1 CEP has been issued for it. The manufacturer submits a PREFEST-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a PREFEST-1 CEP holder for the record. Additionally, the data presented in the PREFEST-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the PREFEST-1 DMF.
A PREFEST-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. PREFEST-1 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 PREFEST-1 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 PREFEST-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for PREFEST-1 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 PREFEST-1 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 PREFEST-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a PREFEST-1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of PREFEST-1 suppliers with NDC on PharmaCompass.
PREFEST-1 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 PREFEST-1 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 PREFEST-1 GMP manufacturer or PREFEST-1 GMP API supplier for your needs.
A PREFEST-1 CoA (Certificate of Analysis) is a formal document that attests to PREFEST-1's compliance with PREFEST-1 specifications and serves as a tool for batch-level quality control.
PREFEST-1 CoA mostly includes findings from lab analyses of a specific batch. For each PREFEST-1 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.
PREFEST-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (PREFEST-1 EP), PREFEST-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (PREFEST-1 USP).
