01 1BIOCON LIMITED
02 1Emcure Pharmaceuticals Limited
03 2Everlight Chemical Industrial Corporation Kuanyin II Plant
04 1Glenmark Life Sciences Limited
05 1Honour Lab Limited
06 3MSN Laboratories Private Limited
07 1MYLAN LABORATORIES LIMITED
08 1Maprimed S.A.
09 1Novartis Pharma Schweizerhalle AG
10 1Ruyuan HEC Pharm Co., Ltd.
11 1SHILPA PHARMA LIFESCIENCES LIMITED
12 1TAPI Czech Industries s.r.o.
13 1Teva Czech Industries s.r.o
14 1Viyash Life Sciences Private Limited
01 1FINGOLIMOD HYDROCHLORIDE
02 2Fingolimod
03 2Fingolimod HCl
04 8Fingolimod Hydrochloride
05 1Fingolimod Hydrochloride (Form-I)
06 1Fingolimod hydrochloride
07 2fingolimod hydrochloride
01 1Argentina
02 1China
03 9India
04 1Israel
05 1Switzerland
06 2Taiwan
07 1U.S.A
08 1Blank
NDC Package Code : 14593-902
Start Marketing Date : 2023-12-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65035-138
Start Marketing Date : 2017-11-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65035-201
Start Marketing Date : 2011-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 57741-3100
Start Marketing Date : 2012-09-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 54893-0025
Start Marketing Date : 2013-12-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 54893-0026
Start Marketing Date : 2014-05-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 54893-0071
Start Marketing Date : 2018-03-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 44139-0103
Start Marketing Date : 2010-09-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 47848-043
Start Marketing Date : 2013-01-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65015-834
Start Marketing Date : 2015-02-19
End Marketing Date : 2026-12-01
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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.
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.
We have 13 companies offering gilenya
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