Synopsis
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
US Patents
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US Exclusivities
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Health Canada Patents
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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
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USDMF
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-04
Pay. Date : 2017-10-18
DMF Number : 29582
Submission : 2015-07-22
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 : 13913
Submission : 1998-12-23
Status :
Type : II
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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 pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Temad- We think of world-class quality.
About the Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Ira...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22033
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22033
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NEWS #PharmaBuzz
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Fluvoxamine 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 Fluvoxamine manufacturer or Fluvoxamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluvoxamine manufacturer or Fluvoxamine supplier.
PharmaCompass also assists you with knowing the Fluvoxamine API Price utilized in the formulation of products. Fluvoxamine API Price is not always fixed or binding as the Fluvoxamine Price is obtained through a variety of data sources. The Fluvoxamine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Desiflu manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Desiflu, including repackagers and relabelers. The FDA regulates Desiflu manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Desiflu 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 Desiflu manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Desiflu supplier is an individual or a company that provides Desiflu active pharmaceutical ingredient (API) or Desiflu finished formulations upon request. The Desiflu suppliers may include Desiflu API manufacturers, exporters, distributors and traders.
click here to find a list of Desiflu suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Desiflu DMF (Drug Master File) is a document detailing the whole manufacturing process of Desiflu active pharmaceutical ingredient (API) in detail. Different forms of Desiflu DMFs exist exist since differing nations have different regulations, such as Desiflu USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Desiflu DMF submitted to regulatory agencies in the US is known as a USDMF. Desiflu USDMF includes data on Desiflu's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Desiflu USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Desiflu suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Desiflu Drug Master File in Japan (Desiflu JDMF) empowers Desiflu API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Desiflu JDMF during the approval evaluation for pharmaceutical products. At the time of Desiflu JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Desiflu suppliers with JDMF on PharmaCompass.
A Desiflu CEP of the European Pharmacopoeia monograph is often referred to as a Desiflu Certificate of Suitability (COS). The purpose of a Desiflu CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Desiflu EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Desiflu to their clients by showing that a Desiflu CEP has been issued for it. The manufacturer submits a Desiflu CEP (COS) as part of the market authorization procedure, and it takes on the role of a Desiflu CEP holder for the record. Additionally, the data presented in the Desiflu CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Desiflu DMF.
A Desiflu CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Desiflu 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 Desiflu suppliers with CEP (COS) on PharmaCompass.
A Desiflu written confirmation (Desiflu WC) is an official document issued by a regulatory agency to a Desiflu manufacturer, verifying that the manufacturing facility of a Desiflu active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Desiflu APIs or Desiflu finished pharmaceutical products to another nation, regulatory agencies frequently require a Desiflu WC (written confirmation) as part of the regulatory process.
click here to find a list of Desiflu 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 Desiflu as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Desiflu 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 Desiflu 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 Desiflu and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Desiflu NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Desiflu suppliers with NDC on PharmaCompass.
Desiflu 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 Desiflu 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 Desiflu GMP manufacturer or Desiflu GMP API supplier for your needs.
A Desiflu CoA (Certificate of Analysis) is a formal document that attests to Desiflu's compliance with Desiflu specifications and serves as a tool for batch-level quality control.
Desiflu CoA mostly includes findings from lab analyses of a specific batch. For each Desiflu 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.
Desiflu may be tested according to a variety of international standards, such as European Pharmacopoeia (Desiflu EP), Desiflu JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Desiflu USP).
