Product Overview

Bicalutamide is a non-steroidal anti-androgen active pharmaceutical ingredient (API).

Bicalutamide is a racemic compound with the R-enantiomer considered to be the active anti-androgen.

It works as an anti-androgen by inhibiting the function of male sexual hormones called androgens.

For this reason, it is often the active ingredient of choice for products employed in the treatment of prostate disease.

This blocks the effect of natural androgens on prostate tissue.

Over time, this helps slow the growth of hormone-dependent tumour cells.

This material is made for industrial use only. It must first be formulated, tested, and approved by regulators.

The API is suitable for blending, granulation, and tablet compression in a GMP setting.

Its solid form supports consistent handling, sampling, and in-process control.

Therapeutic Applications

Bicalutamide is used as an API in anti-androgen medicines. It is not a finished medicine, neither intended for direct patient use.

Common target uses on the product level include:

Treatment of advanced or metastatic prostate cancer

Treatment of locally advanced prostate cancer

Use with other hormone-lowering agents in combined therapy

Specification Parameters

Packaging & Storage

Bicalutamide is packaged in tight, light-resistant containers.

Typical packages include HDPE or fibre drums with inner polyethylene or foil bags. Each container is well labeled with:

Store the API in a cool and dry location. Protect from direct light, heat, or moisture.

Keep the container tightly closed, especially when not in use.

Under the recommended storage conditions, bicalutamide has been shown to remain within specification for its full validated shelf life.

Storage and handling instructions are repeated on the CoA and Safety Data Sheet.

Why Choose Us

We provide bicalutamide as a high-purity, regular API for oral preparations.

Our manufacturing process is done based on tight quality systems and GMP-aligned controls.

You get a complete documentation package with every shipment, including CoA and SDS.

We are able to align our specifications with your internal standards.

Further, we provide support for technical questions on handling, processing, and stability during development and scale-up.