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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

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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, Price,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.

PharmaCompass also assists you with knowing the Diroximel fumarate API Price utilized in the formulation of products. Diroximel fumarate API Price is not always fixed or binding as the Diroximel fumarate Price is obtained through a variety of data sources. The Diroximel fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

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.

Diroximel fumarate Manufacturers

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

Diroximel fumarate Suppliers

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

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

Diroximel fumarate USDMF

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

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

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

Diroximel fumarate Manufacturers | Traders | Suppliers

Diroximel fumarate Manufacturers, Traders, Suppliers 1
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We have 7 companies offering Diroximel fumarate

Get in contact with the supplier of your choice:

  1. TAPI Technology & API Services
  2. Glenmark Life Sciences
  3. HONOUR LAB LTD
  4. Intas Pharmaceuticals
  5. MSN Laboratories
  6. Sterling Pharma Solutions
  7. Zydus Lifesciences
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.