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About Tafamidis Meglumine API

Product
  • Therapeutic Category心臓血管

  • API Technology

    Synthetic

  • Dose Form

    Soft Gel Capsule

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    Brazil DMF, USDMF

Mechanism of Action

Tafamidis Meglumine is a drug used to treat transthyretin (TTR) amyloidosis, a rare genetic disease characterized by the buildup of abnormal proteins in various tissues and organs, including the heart, peripheral nerves, and eyes.

The mechanism of action of Tafamidis Meglumine is based on its ability to stabilize the TTR tetramer, which is the native form of the protein. Tafamidis Meglumine binds to the TTR protein and prevents it from undergoing a conformational change that would normally lead to its aggregation and formation of amyloid fibrils. By stabilizing the TTR tetramer, Tafamidis Meglumine slows down the progression of TTR amyloidosis and helps to preserve the function of affected tissues and organs.

In addition, Tafamidis Meglumine has been shown to have an anti-inflammatory effect, which may also contribute to its therapeutic effects in TTR amyloidosis.

Indication

Tafamidis Meglumine is a medication used to treat transthyretin amyloid cardiomyopathy (ATTR-CM), a type of heart disease caused by buildup of amyloid deposits in the heart. It works by stabilizing the transthyretin protein, which helps to prevent the formation of amyloid deposits and slow the progression of heart damage.

Tafamidis Meglumine is indicated for the treatment of transthyretin amyloid cardiomyopathy in adult patients with stage F2 or F3 cardiac symptoms (based on the New York Heart Association [NYHA] functional classification).

It is important to note that Tafamidis Meglumine is not a cure for transthyretin amyloid cardiomyopathy, but it can help to slow the progression of the disease and improve symptoms in some patients.

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Tafamidis Meglumine API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Tafamidis Meglumine API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

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