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Athena Athena

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

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01 Lonza Inc & Lonza America Inc (1)

02 Blank (3)

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01 TOLRESTAT (3)

02 TOLRESTAT AND ITS INTERMEDIATES (1)

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01 U.S.A (1)

02 Blank (3)

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01 Inactive (4)

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01 Blank (4)

URL Supplier Web Content
6144
Inactive
1985-11-01
N/A
II
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ETHYL CORP

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6559
Inactive
1986-08-29
N/A
II
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ETHYL CORP

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6163
Inactive
1985-11-21
N/A
II
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GANES CHEMICALS INC PENNSVILLE DIV

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6134
Inactive
1985-12-16
N/A
II
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Looking for 82964-04-3 / Tolrestat API manufacturers, exporters & distributors?

Tolrestat manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Tolrestat

Synonyms

82964-04-3, Alredase, Lorestat, Tolrestatin, Ay-27773, Tolrestatum

Cas Number

82964-04-3

Unique Ingredient Identifier (UNII)

0T93LG5NMK

About Tolrestat

Tolrestat (INN) (AY-27773) is an aldose reductase inhibitor which was approved for the control of certain diabetic complications. While it was approved for marketed in several countries, it failed a Phase III trial in the U.S. due to toxicity and never received FDA approval. It was sold under the tradename Alredase but was discontinued by Wyeth in 1997 because of the risk of severe liver toxicity and death.

Alrestin Manufacturers

A Alrestin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alrestin, including repackagers and relabelers. The FDA regulates Alrestin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alrestin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Alrestin Suppliers

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

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

Alrestin USDMF

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

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

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

Alrestin Manufacturers | Traders | Suppliers

Alrestin Manufacturers, Traders, Suppliers 1
99

We have 1 companies offering Alrestin

Get in contact with the supplier of your choice:

  1. Lonza Inc & Lonza America Inc
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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