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API SUPPLIERS
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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USDMF
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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INTERMEDIATE SUPPLIERS
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Agomelatin Zentiva
Dosage Form : Filmtabl
Dosage Strength : 25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Agomelatin Zentiva
Dosage Form : Filmtabl
Dosage Strength : 25mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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Market Place
APIs
Reply
08 Feb 2019
Reply
25 Oct 2017
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ANALYTICAL
ABOUT THIS PAGE
53
PharmaCompass offers a list of Agomelatine 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 Agomelatine manufacturer or Agomelatine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Agomelatine manufacturer or Agomelatine supplier.
PharmaCompass also assists you with knowing the Agomelatine API Price utilized in the formulation of products. Agomelatine API Price is not always fixed or binding as the Agomelatine Price is obtained through a variety of data sources. The Agomelatine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Agomelatine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Agomelatine, including repackagers and relabelers. The FDA regulates Agomelatine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Agomelatine 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 Agomelatine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Agomelatine supplier is an individual or a company that provides Agomelatine active pharmaceutical ingredient (API) or Agomelatine finished formulations upon request. The Agomelatine suppliers may include Agomelatine API manufacturers, exporters, distributors and traders.
click here to find a list of Agomelatine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Agomelatine DMF (Drug Master File) is a document detailing the whole manufacturing process of Agomelatine active pharmaceutical ingredient (API) in detail. Different forms of Agomelatine DMFs exist exist since differing nations have different regulations, such as Agomelatine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Agomelatine DMF submitted to regulatory agencies in the US is known as a USDMF. Agomelatine USDMF includes data on Agomelatine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Agomelatine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Agomelatine suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Agomelatine Drug Master File in Korea (Agomelatine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Agomelatine. The MFDS reviews the Agomelatine KDMF as part of the drug registration process and uses the information provided in the Agomelatine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Agomelatine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Agomelatine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Agomelatine suppliers with KDMF on PharmaCompass.
A Agomelatine written confirmation (Agomelatine WC) is an official document issued by a regulatory agency to a Agomelatine manufacturer, verifying that the manufacturing facility of a Agomelatine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Agomelatine APIs or Agomelatine finished pharmaceutical products to another nation, regulatory agencies frequently require a Agomelatine WC (written confirmation) as part of the regulatory process.
click here to find a list of Agomelatine 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 Agomelatine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Agomelatine 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 Agomelatine 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 Agomelatine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Agomelatine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Agomelatine suppliers with NDC on PharmaCompass.
Agomelatine 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 Agomelatine 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 Agomelatine GMP manufacturer or Agomelatine GMP API supplier for your needs.
A Agomelatine CoA (Certificate of Analysis) is a formal document that attests to Agomelatine's compliance with Agomelatine specifications and serves as a tool for batch-level quality control.
Agomelatine CoA mostly includes findings from lab analyses of a specific batch. For each Agomelatine 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.
Agomelatine may be tested according to a variety of international standards, such as European Pharmacopoeia (Agomelatine EP), Agomelatine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Agomelatine USP).
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