Dabired (Dabigatran Pellets) API

作用机制

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.

适应症

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的专长

Dr. Reddy's总部位于印度海得拉巴，是全球领先的活性药物成分（API）供应商之一。 Dr. Reddy's的API业务是美国、欧洲、巴西、拉丁美洲、日本、中国、韩国和新兴市场的制药公司的首选合作伙伴。

Dr. Reddy's博士的API业务在过去30多年来在开发和制造复杂API（如类固醇，多肽，复杂长链分子和高效API（HPAPI /肿瘤药物））方面所建立的深厚技术优势中茁壮成长。 我们在知识产权和法规事务方面的实力可以帮助我们始终如一地达到并超越监管标准，从而为这一专业知识提供补充。 Dr. Reddy's博士 Dabired (Dabigatran Pellets) API是研发，知识产权和监管方面广泛专业知识的结果。

帮助我们的客户率先进入市场的关键组成部分是响应式供应链。 我们通过确保所有设施都高效运行并达到最新的质量，安全和生产率标准来实现这一目标。 业务和工厂之间的强大互联可以快速响应动态的市场变化，从而避免短缺并满足需求的突然激增。