Synopsis
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS
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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
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2014-04-25
DMF Number : 28148
Submission : 2014-04-27
Status :
Type : II
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-20
Pay. Date : 2014-06-16
DMF Number : 28225
Submission : 2014-04-22
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 the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Synnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.
About the Company : Synnat Pharma is a fast-growing pharmaceutical company dedicated to the identification, development, production and distribution of potent phytochemicals and botanical extracts. AP...
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...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...
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Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Fingolimod Hydrochloride 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 Fingolimod Hydrochloride manufacturer or Fingolimod Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fingolimod Hydrochloride manufacturer or Fingolimod Hydrochloride supplier.
PharmaCompass also assists you with knowing the Fingolimod Hydrochloride API Price utilized in the formulation of products. Fingolimod Hydrochloride API Price is not always fixed or binding as the Fingolimod Hydrochloride Price is obtained through a variety of data sources. The Fingolimod Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A gilenya manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gilenya, including repackagers and relabelers. The FDA regulates gilenya manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gilenya 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 gilenya manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A gilenya supplier is an individual or a company that provides gilenya active pharmaceutical ingredient (API) or gilenya finished formulations upon request. The gilenya suppliers may include gilenya API manufacturers, exporters, distributors and traders.
click here to find a list of gilenya suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A gilenya DMF (Drug Master File) is a document detailing the whole manufacturing process of gilenya active pharmaceutical ingredient (API) in detail. Different forms of gilenya DMFs exist exist since differing nations have different regulations, such as gilenya USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A gilenya DMF submitted to regulatory agencies in the US is known as a USDMF. gilenya USDMF includes data on gilenya's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The gilenya USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of gilenya 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 gilenya Drug Master File in Japan (gilenya JDMF) empowers gilenya 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 gilenya JDMF during the approval evaluation for pharmaceutical products. At the time of gilenya 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 gilenya suppliers with JDMF on PharmaCompass.
A gilenya CEP of the European Pharmacopoeia monograph is often referred to as a gilenya Certificate of Suitability (COS). The purpose of a gilenya CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of gilenya EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of gilenya to their clients by showing that a gilenya CEP has been issued for it. The manufacturer submits a gilenya CEP (COS) as part of the market authorization procedure, and it takes on the role of a gilenya CEP holder for the record. Additionally, the data presented in the gilenya CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the gilenya DMF.
A gilenya CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. gilenya 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 gilenya suppliers with CEP (COS) on PharmaCompass.
A gilenya written confirmation (gilenya WC) is an official document issued by a regulatory agency to a gilenya manufacturer, verifying that the manufacturing facility of a gilenya active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting gilenya APIs or gilenya finished pharmaceutical products to another nation, regulatory agencies frequently require a gilenya WC (written confirmation) as part of the regulatory process.
click here to find a list of gilenya 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 gilenya as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for gilenya 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 gilenya 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 gilenya and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a gilenya NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of gilenya suppliers with NDC on PharmaCompass.
gilenya 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 gilenya 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 gilenya GMP manufacturer or gilenya GMP API supplier for your needs.
A gilenya CoA (Certificate of Analysis) is a formal document that attests to gilenya's compliance with gilenya specifications and serves as a tool for batch-level quality control.
gilenya CoA mostly includes findings from lab analyses of a specific batch. For each gilenya 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.
gilenya may be tested according to a variety of international standards, such as European Pharmacopoeia (gilenya EP), gilenya JP (Japanese Pharmacopeia) and the US Pharmacopoeia (gilenya USP).
