Product Overview

Ursodeoxycholic acid API , or UDCA, also referred to as ursodiol, is a secondary bile acid that is present in trace amounts in human bile.

White to off-white crystalline powder when pure. It is water-insoluble but alcohol-soluble in titanic amounts.

UDCA is an asset because it is less “harsh” than certain other bile acids.

It also prevents bile from being more toxic to liver cells and may even increase bile flow.

Such an action is desirable to the function of the liver in most conditions where bile is concentrated or cholesterol-rich.

UDCA exerts its effect by multiple straightforward, interrelated mechanisms.

It lowers the cholesterol content of bile, preventing stone formation and slowly decreasing the size of certain stones.

It also replaces more toxic bile acids in the pool of bile, thus protecting liver and bile duct cell membranes.

UDCA can actually increase the secretion of bile, too.

These multiple effects are the causes UDCA is used in gallbladder and liver therapy.

The drug is synthesized under controlled conditions to meet specified quality standards to be used as an active pharmaceutical ingredient.

Therapeutic Applications

UDCA API is supplied to pharmaceutical industries to make drugs for liver and bile disorders.

It is used in formulations for stimulating bile flow and reducing the bile cholesterol content.

UDCA, in final preparations, can be used where the composition of the bile would need to be altered.

The API is also integrated into drugs used in the treatment of certain chronic cholestatic liver diseases.

Another application is in preparations utilized to prevent the creation of bile stones in high-risk conditions.

Pediatric use is restricted and should follow strict medical guidance.

Specification Parameters

Packaging & Storage:

UDCA API may be supplied in fibre or HDPE drums with a food-grade inner liner.

It comes in pack sizes of 5 kg, 10 kg, and 25 kg as standard pack sizes.

Other pack sizes are also available to meet specific customers’ needs.

Keep the product in a dry, cool area. The optimum temperature is less than 25 °C.

Store tightly sealed containers when not in use. Avoid intense heat or direct sunlight.

Keep the API out of excessive humidity. Stability and potency are maintained with good storage conditions.

36 months’ shelf life after date of manufacture when stored according to instructions.

Use immediately upon opening a container. If partially filling drums, reseal tightly to reduce exposure to moisture and air.

During transit, have drums upright and away from water, sunlight, and impact.

Comply with all applicable laws for handling and transportation of chemical products.

Why Choose Us

Actiza Pharmaceutical Pvt Ltd is a specialist in the production and worldwide supply of pure ursodeoxycholic acid API, as per rigorous pharmacopeia standards.

In our GMP-certified processing facilities, we follow rigorous quality control protocols from raw material sourcing to end packaging.