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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTAPI, 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 : 2019-08-22

Pay. Date : 2019-04-01

DMF Number : 33752

Submission : 2019-04-03

Status : Active

Type : II

TAPI Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothHonour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.

GDUFA

DMF Review : Complete

Rev. Date : 2021-11-10

Pay. Date : 2021-09-02

DMF Number : 36019

Submission : 2021-09-20

Status : Active

Type : II

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04

PEGS Boston Summit
Not Confirmed

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PEGS Boston Summit
Not Confirmed

Looking for 1577222-14-0 / Diroximel fumarate API manufacturers, exporters & distributors?

Diroximel fumarate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Diroximel fumarate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Diroximel fumarate manufacturer or Diroximel fumarate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Diroximel fumarate manufacturer or Diroximel fumarate supplier.

API | Excipient name

Diroximel fumarate

Synonyms

1577222-14-0, 2-(2,5-dioxopyrrolidin-1-yl)ethyl methyl fumarate, Alks-8700, Vumerity, Diroximel fumarete, Rdc-5108

Cas Number

1577222-14-0

Unique Ingredient Identifier (UNII)

K0N0Z40J3W

About Diroximel fumarate

Multiple Sclerosis (MS) is a chronic, debilitating neurological disease that can lead to profound cognitive and physical symptoms, severely affecting quality of life. It is the main cause of neurological disability not caused by trauma in the young adult population of both North America and Europe. Relapsing-remitting forms of MS lead to neurological symptoms that resolve and recur periodically. More than 80% of patients suffering from this disease have relapsing-remitting MS. Diroximel fumarate is a new drug from the fumarate class formulated to treat various relapsing forms of MS. This drug is bioequivalent to [Dimethyl fumarate](initially manufactured in 2013), but is less likely to cause gastrointestinal side effects, owing to its unique chemical structure. Diroximel fumarate was formulated by Alkermes in collaboration with Biogen, and was approved by the FDA in October 2019 and by the EMA in November 2021.

BIIB098 Manufacturers

A BIIB098 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BIIB098, including repackagers and relabelers. The FDA regulates BIIB098 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BIIB098 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 BIIB098 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.

BIIB098 Suppliers

A BIIB098 supplier is an individual or a company that provides BIIB098 active pharmaceutical ingredient (API) or BIIB098 finished formulations upon request. The BIIB098 suppliers may include BIIB098 API manufacturers, exporters, distributors and traders.

click here to find a list of BIIB098 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.

BIIB098 USDMF

A BIIB098 DMF (Drug Master File) is a document detailing the whole manufacturing process of BIIB098 active pharmaceutical ingredient (API) in detail. Different forms of BIIB098 DMFs exist exist since differing nations have different regulations, such as BIIB098 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A BIIB098 DMF submitted to regulatory agencies in the US is known as a USDMF. BIIB098 USDMF includes data on BIIB098's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BIIB098 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of BIIB098 suppliers with USDMF on PharmaCompass.

BIIB098 Manufacturers | Traders | Suppliers

BIIB098 Manufacturers, Traders, Suppliers 1
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.