Calcium Dobesilate

Microangiopathy is a common complication of chronic diseases such as diabetes and chronic venous insufficiency. Its long-term progression can lead to serious adverse outcomes including retinal injury and decreased renal function, and there has been a persistent lack of targeted microvascular protection regimens in clinical practice. Calcium dobesilate is a microvascular protective agent that improves the pathological damage of microvascular walls by reducing vascular permeability, inhibiting platelet aggregation and alleviating blood hyperviscosity. At present, it is widely used in the clinical treatment of diseases such as diabetic retinopathy, diabetic nephropathy, chronic venous insufficiency and varicose vein syndrome, covering patient groups in multiple departments including endocrinology, ophthalmology and vascular surgery.

Currently, the global market size of calcium dobesilate is stably above 1.2 billion US dollars, and the annual growth rate of the Chinese market remains at around 8%, making it a commonly used mature variety in the field of microangiopathy. The domestic competitive landscape is dominated by generic drugs, with more than 15 preparation enterprises having passed the consistency evaluation. It has been included in multiple batches of provincial centralized procurement, and the price reduction of winning bids is generally 50%-70%, which drives the continuous increase in demand for cost-effective active pharmaceutical ingredients (APIs) from downstream preparation enterprises. At present, there are nearly 10 domestic API registration enterprises, which can fully support the demand for preparation capacity expansion.

The original research enterprise of calcium dobesilate is Ebewe Pharma Ges.m.b.H. Austria, with the original brand name "Doxium". The core compound patent expired globally before 2000. At present, the mainstream dosage form is capsule, with conventional specifications of 0.25g and 0.5g. The original preparation has been included in the China Listed Drug Catalogue as the reference listed drug, and is also included in the FDA Reference Listed Drug Directory. According to the domestic API registration platform, there are currently 12 calcium dobesilate API registration numbers with A status, and more than 30 domestic enterprises have obtained approval for domestic preparations, which can meet the production needs of different dosage forms. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of calcium dobesilate impurity reference standards. Most products are directly available in stock, and spot orders placed before 16:00 can be shipped on the same day. All products comply with the regulatory requirements of multiple regions including the Chinese Pharmacopoeia and FDA, and can fully support the whole-process R&D and production scenarios such as API quality research and preparation consistency evaluation.