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About Dabigatran Etexilate Mesylate API

Product
  • Therapeutic CategoryCardiovascular

  • API Technology

    Synthetic

  • Dose Form

    Oral Solid/Capsules

  • Dr Reddy's Development Status

    Available (Commercial)

  • Available Regulatory Filing

    USDMF, Brazil DMF, EUDMF, Canada DMF, China DMF, CEP Submitted, Russia DMF

Mechanism of Action

Dabigatran and its acyl glucuronides are competitive, direct thrombin inhibitors. Because thrombin (serine protease) enables the conversion of fibrinogen into fibrin during the coagulation cascade, its inhibition prevents the development of a thrombus. Both free and clot-bound thrombin, and thrombin-induced platelet aggregation are inhibited by the active moieties.

Indication

PRADAXA is a direct thrombin inhibitor indicated:

  • To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation
  • For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days
  • To reduce the risk of recurrence of DVT and PE in patients who have been previously treated
  • For the prophylaxis of DVT and PE in patients who have undergone hip replacement surgery

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 Dabigatran Etexilate Mesylate 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 Dabigatran Etexilate Mesylate 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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FAQs

What is Dabigatran Etexilate Mesylate API used for?
  • Prevents stroke and systemic embolism in patients with non-valvular atrial fibrillation
    Treats deep vein thrombosis (DVT) and pulmonary embolism (PE)

What is the dosage form and strength currently available for Dabigatran Etexilate Mesylate?
  • Available as oral capsules: 75 mg, 110 mg, 150 mg

How do you store Dabigatran Etexilate Mesylate API?
  • Store at 20°C to 25°C (68°F to 77°F), in the original container, protect from moisture

Disclaimer: Products under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act (Bolar Exemption) and not for commercial sale.