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の専門知識・技術

ハイデラバード（インド）に本社を構えるDr. Reddy’s Laboratoriesは、世界的に有名な原薬（API）供給業者です。Dr. Reddy’sのAPIビジネスは米国、ヨーロッパ、ブラジル、南米、日本、中国、韓国、その他の新興市場において製薬会社の推奨パートナーとなっています。

Dr. Reddy’sのAPIビジネスは、ステロイド、ペプチド、複合長鎖分子、高薬理活性API（HPAPI /腫瘍学薬）など、複合APIの開発・製造において、30年以上にわたり高度な技術的実績を築き上げ、成長しています。この専門知識・技術は弊社の知的財産および規制関連業務の実績と共に、一貫して規制基準を満たし、それを超える優れた価値を生み出しています。Dr. Reddyの(-) API, R&D (研究開発)、IP、規制の高度な専門知識・技能の結果です。

顧客が真っ先に市場に参入するのに重要な要素は、機敏な供給網です。弊社は全施設を効率的に、そしてコストを最適化して稼働させ、品質と安全性、また、生産性の最新基準に従うことで、そうした供給網を実現させます。オフィスと工場の結びつきを強化し、ダイナミックな市場の変化に迅速に対応しています。そうした理由から、弊社は不足を解消して突発的な供給を満たすことができるのです。