Dabired (Dabigatran Pellets) API

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

About Dabired

Dabired is ready to fill Dabigatran Etexilate Mesylate 42.04% w/w pellets which are designed to integrate seamlessly into your encapsulation process. Manufactured using the Wurster Coating Process, the layering of Dabired pellets, and the components of each layer, have been intricately designed and optimised applying QbD methodologies.

The Dabired Advantage

• Bio- compliant

Dabired has successfully demonstrated in-vivo bio-equivalence which makes it possible to significantly accelerate your time to market.

• Faster formulation development

Dabired pellets are ready to fill into capsules, and help reduce the steps to the complete formulation development

• Significant cost savings

Dabired gives you a great reduction in cost including research , manpower along with freeing up manufacturing capacities.

• Process controlled impurity profile

Robust process design, packaging and analytical methods ensure well controlled impurity profile, including critical amide degradation impurities

• Order Flexibility

Dabired comes to you in quantities that you need. It is available in stable packs, ranging from kilos to metric tonnes

The Complete Package

With Dabired, Dr. Reddy’s API business offers an integrated package of high-quality product, along with services that give you a distinct advantage.

• R&D capabilities

Fully integrated expertise across API’s and formulation development, backed by bio-clinical and regulatory teams.

• Supply assurance

Capacities and supply chain plans are designed to meet global requirements for Dabired and the API.

• Global reach                                                                                            

Dabired brings global regulatory requirements, to enable your geographic expansion plans.

Value-added services

• Regulatory services

Our team of regulatory experts can support filing activities in countries of interest.

• Tech transfer

Knowledge transfer support, according to the customer requirements, to enable local manufacturing.

•  Bio-study design support

An experienced clinical pharmacokinetic team, available to extend their support.

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 Dabired (Dabigatran Pellets) 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 Dabired (Dabigatran Pellets) 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.