Dabired (Dabigatran Pellets) API

Mecanismo de acción

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.

Indicación

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.

Experiencia de Dr. Reddy

Con sede en Hyderabad, India, Dr. Reddy's Laboratories es uno de los principales proveedores de ingredientes farmacéuticos activos (API) a nivel mundial. El negocio API de Dr. Reddy es considerado como un socio preferido de las compañías farmacéuticas en los Estados Unidos, Europa, Brasil, América Latina, Japón, China, Corea y los mercados emergentes.

El negocio de API de Dr. Reddy se nutre de las fortalezas técnicas profundas establecidas en los últimos 30 años en el desarrollo y fabricación de API complejas como esteroides, péptidos, moléculas complejas de cadena larga y API altamente potentes (HPAPI / medicamentos oncológicos). Esta experiencia se complementa con nuestra destreza en propiedad intelectual y asuntos regulatorios que nos ayudan a cumplir y superar los estándares regulatorios de manera consistente. Los APIs de Dr. Reddy´s Dabired (Dabigatran Pellets) es el resultado de la amplia experiencia en R&D, IP y Normatividad Aplicable.

Un componente clave para ayudar a nuestros clientes a ser los primeros en comercializar es una cadena de suministro receptiva. Logramos esto al asegurarnos de que todas nuestras instalaciones funcionen de manera eficiente y con los últimos estándares de calidad, seguridad y productividad. Una fuerte interconexión entre las empresas y las fábricas permite una reacción rápida a los cambios dinámicos del mercado, de modo que podamos evitar la escasez y satisfacer los repentinos aumentos de la demanda.