About Dabigatran Etexilate Mesylate API

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.
RFQ Form
FAQs
Prevents stroke and systemic embolism in patients with non-valvular atrial fibrillation
Treats deep vein thrombosis (DVT) and pulmonary embolism (PE)
Available as oral capsules: 75 mg, 110 mg, 150 mg
Store at 20°C to 25°C (68°F to 77°F), in the original container, protect from moisture