Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Europe
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
NDC
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Neuland Laboratories- A dedicated 100% API provider.
NDC
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-15
Pay. Date : 2022-03-30
DMF Number : 36646
Submission : 2021-12-30
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-26
Pay. Date : 2021-12-17
DMF Number : 35473
Submission : 2021-01-22
Status :
Type : II
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38220
Submission : 2023-03-27
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36636
Submission : 2022-02-25
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36947
Submission : 2022-03-31
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
INTERMEDIATE SUPPLIERS
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
Patent Expiration Date : 2028-11-07
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
US Patent Number : 11459305
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 213388
Patent Use Code : U-2842
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-11-07
Patent Expiration Date : 2034-03-14
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
US Patent Number : 11045470
Drug Substance Claim :
Drug Product Claim :
Application Number : 213388
Patent Use Code : U-2842
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2034-03-14
Patent Expiration Date : 2038-08-20
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
US Patent Number : 12083227
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 213388
Patent Use Code : U-2842
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-08-20
Patent Expiration Date : 2040-08-27
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
US Patent Number : 11690845
Drug Substance Claim :
Drug Product Claim :
Application Number : 213388
Patent Use Code : U-3655
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-08-27
Patent Expiration Date : 2029-07-06
ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
US Patent Number : 7419983
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 213388
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2029-07-06
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Elagolix 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 Elagolix manufacturer or Elagolix supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Elagolix manufacturer or Elagolix supplier.
PharmaCompass also assists you with knowing the Elagolix API Price utilized in the formulation of products. Elagolix API Price is not always fixed or binding as the Elagolix Price is obtained through a variety of data sources. The Elagolix Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Elagolix Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elagolix Sodium, including repackagers and relabelers. The FDA regulates Elagolix Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elagolix Sodium 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 Elagolix Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Elagolix Sodium supplier is an individual or a company that provides Elagolix Sodium active pharmaceutical ingredient (API) or Elagolix Sodium finished formulations upon request. The Elagolix Sodium suppliers may include Elagolix Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Elagolix Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Elagolix Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Elagolix Sodium active pharmaceutical ingredient (API) in detail. Different forms of Elagolix Sodium DMFs exist exist since differing nations have different regulations, such as Elagolix Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Elagolix Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Elagolix Sodium USDMF includes data on Elagolix Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Elagolix Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Elagolix Sodium suppliers with USDMF on PharmaCompass.
A Elagolix Sodium written confirmation (Elagolix Sodium WC) is an official document issued by a regulatory agency to a Elagolix Sodium manufacturer, verifying that the manufacturing facility of a Elagolix Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Elagolix Sodium APIs or Elagolix Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Elagolix Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Elagolix Sodium 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 Elagolix Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Elagolix Sodium 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 Elagolix Sodium 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 Elagolix Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elagolix Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Elagolix Sodium suppliers with NDC on PharmaCompass.
Elagolix Sodium 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 Elagolix Sodium 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 Elagolix Sodium GMP manufacturer or Elagolix Sodium GMP API supplier for your needs.
A Elagolix Sodium CoA (Certificate of Analysis) is a formal document that attests to Elagolix Sodium's compliance with Elagolix Sodium specifications and serves as a tool for batch-level quality control.
Elagolix Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Elagolix Sodium 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.
Elagolix Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Elagolix Sodium EP), Elagolix Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elagolix Sodium USP).
