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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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
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REF. STANDARDS & IMPURITIES
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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 Fingolimod manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fingolimod, including repackagers and relabelers. The FDA regulates Fingolimod manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fingolimod 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 Fingolimod manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fingolimod supplier is an individual or a company that provides Fingolimod active pharmaceutical ingredient (API) or Fingolimod finished formulations upon request. The Fingolimod suppliers may include Fingolimod API manufacturers, exporters, distributors and traders.
click here to find a list of Fingolimod suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fingolimod DMF (Drug Master File) is a document detailing the whole manufacturing process of Fingolimod active pharmaceutical ingredient (API) in detail. Different forms of Fingolimod DMFs exist exist since differing nations have different regulations, such as Fingolimod USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fingolimod DMF submitted to regulatory agencies in the US is known as a USDMF. Fingolimod USDMF includes data on Fingolimod's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fingolimod USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fingolimod 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 Fingolimod Drug Master File in Japan (Fingolimod JDMF) empowers Fingolimod 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 Fingolimod JDMF during the approval evaluation for pharmaceutical products. At the time of Fingolimod 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 Fingolimod suppliers with JDMF on PharmaCompass.
A Fingolimod CEP of the European Pharmacopoeia monograph is often referred to as a Fingolimod Certificate of Suitability (COS). The purpose of a Fingolimod CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fingolimod EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fingolimod to their clients by showing that a Fingolimod CEP has been issued for it. The manufacturer submits a Fingolimod CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fingolimod CEP holder for the record. Additionally, the data presented in the Fingolimod CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fingolimod DMF.
A Fingolimod CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fingolimod 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 Fingolimod suppliers with CEP (COS) on PharmaCompass.
A Fingolimod written confirmation (Fingolimod WC) is an official document issued by a regulatory agency to a Fingolimod manufacturer, verifying that the manufacturing facility of a Fingolimod active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fingolimod APIs or Fingolimod finished pharmaceutical products to another nation, regulatory agencies frequently require a Fingolimod WC (written confirmation) as part of the regulatory process.
click here to find a list of Fingolimod 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 Fingolimod as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fingolimod 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 Fingolimod 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 Fingolimod and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fingolimod NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fingolimod suppliers with NDC on PharmaCompass.
Fingolimod 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 Fingolimod 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 Fingolimod GMP manufacturer or Fingolimod GMP API supplier for your needs.
A Fingolimod CoA (Certificate of Analysis) is a formal document that attests to Fingolimod's compliance with Fingolimod specifications and serves as a tool for batch-level quality control.
Fingolimod CoA mostly includes findings from lab analyses of a specific batch. For each Fingolimod 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.
Fingolimod may be tested according to a variety of international standards, such as European Pharmacopoeia (Fingolimod EP), Fingolimod JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fingolimod USP).
