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List of Drug Master Files (DMF) of Idebenone Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Industriale Chimica s.r.l. (1)

02 Suzhou Lixin Pharmaceutical (1)

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01 IDEBENONE (1)

02 IDEBENONE (NON-STERILE) (1)

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01 China (1)

02 Italy (1)

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01 Active (2)

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01 Blank (2)

URL Supplier Web Content
18428
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2005-06-08
N/A
II
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URL Supplier Web Content
32079
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2017-08-28
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Looking for 58186-27-9 / Idebenone API manufacturers, exporters & distributors?

Idebenone manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Idebenone

Synonyms

58186-27-9, 2-(10-hydroxydecyl)-5,6-dimethoxy-3-methylcyclohexa-2,5-diene-1,4-dione, Idebenona, Idebenonum, Sovrima, Hydroxydecyl ubiquinone

Cas Number

58186-27-9

Unique Ingredient Identifier (UNII)

HB6PN45W4J

Idebenone Manufacturers

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

Idebenone Suppliers

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

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

Idebenone USDMF

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

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

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

Idebenone Manufacturers | Traders | Suppliers

Idebenone Manufacturers, Traders, Suppliers 1
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We have 2 companies offering Idebenone

Get in contact with the supplier of your choice:

  1. Industriale Chimica s.r.l.
  2. Suzhou Lixin 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.
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