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01 1Apotex Pharmachem

02 1Dipharma

03 1Glenmark Life Sciences

04 1Hetero Drugs

05 1Lupin Ltd

06 2MSN Laboratories

07 1Micro Labs Limited

08 1Zhejiang Jiuzhou Pharmaceutical

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PharmaCompass

01

The Generic Rx Session
Not Confirmed

03

The Generic Rx Session
Not Confirmed

04

The Generic Rx Session
Not Confirmed

04

The Generic Rx Session
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2021-10-07

Pay. Date : 2021-07-13

DMF Number : 36077

Submission : 2021-08-18

Status : Active

Type : II

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05

The Generic Rx Session
Not Confirmed

06

The Generic Rx Session
Not Confirmed

06

07

The Generic Rx Session
Not Confirmed

Looking for 106308-44-5 / Rufinamide API manufacturers, exporters & distributors?

Rufinamide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Rufinamide 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 Rufinamide manufacturer or Rufinamide supplier for your needs.

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

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

API | Excipient name

Rufinamide

Synonyms

106308-44-5, Banzel, Inovelon, 1-(2,6-difluorobenzyl)-1h-1,2,3-triazole-4-carboxamide, Cgp 33101, Cgp-33101

Cas Number

106308-44-5

Unique Ingredient Identifier (UNII)

WFW942PR79

About Rufinamide

Rufinamide is a triazole derivative and an anticonvulsant medication to treat seizure disorders like Lennox-Gastuat syndrome, a form of childhood epilepsy. Clinical trials suggest its efficacy in the treatment of partial seizures.

Rufinamide Manufacturers

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

Rufinamide Suppliers

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

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

Rufinamide USDMF

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

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

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

Rufinamide Manufacturers | Traders | Suppliers

Rufinamide Manufacturers, Traders, Suppliers 1
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We have 8 companies offering Rufinamide

Get in contact with the supplier of your choice:

  1. Apotex Pharmachem
  2. Dipharma
  3. Glenmark Life Sciences
  4. Hetero Drugs
  5. Lupin Ltd
  6. Micro Labs Limited
  7. MSN Laboratories
  8. Zhejiang Jiuzhou Pharmaceutical
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.