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Looking for 162359-56-0 / Fingolimod Hydrochloride API manufacturers, exporters & distributors?

Fingolimod Hydrochloride manufacturers, exporters & distributors 1

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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.

API | Excipient name

Fingolimod Hydrochloride

Synonyms

162359-56-0, Fty720, Fingolimod hcl, Gilenia, Gilenya, Fty 720

Cas Number

162359-56-0

Unique Ingredient Identifier (UNII)

G926EC510T

About Fingolimod Hydrochloride

A sphingosine-derivative and IMMUNOSUPPRESSIVE AGENT that blocks the migration and homing of LYMPHOCYTES to the CENTRAL NERVOUS SYSTEM through its action on SPHINGOSINE 1-PHOSPHATE RECEPTORS. It is used in the treatment of MULTIPLE SCLEROSIS.

Fingolimod Hydrochloride Manufacturers

A Fingolimod Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fingolimod Hydrochloride, including repackagers and relabelers. The FDA regulates Fingolimod Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fingolimod Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Fingolimod Hydrochloride Suppliers

A Fingolimod Hydrochloride supplier is an individual or a company that provides Fingolimod Hydrochloride active pharmaceutical ingredient (API) or Fingolimod Hydrochloride finished formulations upon request. The Fingolimod Hydrochloride suppliers may include Fingolimod Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Fingolimod Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Fingolimod Hydrochloride USDMF

A Fingolimod Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Fingolimod Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Fingolimod Hydrochloride DMFs exist exist since differing nations have different regulations, such as Fingolimod Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Fingolimod Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Fingolimod Hydrochloride USDMF includes data on Fingolimod Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fingolimod Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Fingolimod Hydrochloride suppliers with USDMF on PharmaCompass.

Fingolimod Hydrochloride JDMF

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 Hydrochloride Drug Master File in Japan (Fingolimod Hydrochloride JDMF) empowers Fingolimod Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Fingolimod Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.

Fingolimod Hydrochloride CEP

A Fingolimod Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Fingolimod Hydrochloride Certificate of Suitability (COS). The purpose of a Fingolimod Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fingolimod Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fingolimod Hydrochloride to their clients by showing that a Fingolimod Hydrochloride CEP has been issued for it. The manufacturer submits a Fingolimod Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fingolimod Hydrochloride CEP holder for the record. Additionally, the data presented in the Fingolimod Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fingolimod Hydrochloride DMF.

A Fingolimod Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fingolimod Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Fingolimod Hydrochloride WC

A Fingolimod Hydrochloride written confirmation (Fingolimod Hydrochloride WC) is an official document issued by a regulatory agency to a Fingolimod Hydrochloride manufacturer, verifying that the manufacturing facility of a Fingolimod Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Fingolimod Hydrochloride APIs or Fingolimod Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Fingolimod Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Fingolimod Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Fingolimod Hydrochloride NDC

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 Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Fingolimod Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Hydrochloride 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Fingolimod Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fingolimod Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Fingolimod Hydrochloride suppliers with NDC on PharmaCompass.

Fingolimod Hydrochloride GMP

Fingolimod Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Fingolimod Hydrochloride GMP API supplier for your needs.

Fingolimod Hydrochloride CoA

A Fingolimod Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Fingolimod Hydrochloride's compliance with Fingolimod Hydrochloride specifications and serves as a tool for batch-level quality control.

Fingolimod Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Fingolimod Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Fingolimod Hydrochloride EP), Fingolimod Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fingolimod Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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