Silodosin Capsule 4mg & 8mg Suppliers & Bulk Manufacturers

Available Forms: Capsule

Available Strengths: 4mg & 8mg

Reference Brands: Silodyx (US & EU), Rapaflo (USA), Urorec(EU)

Category: Urology

Silodosin is a powerful alpha-blocker used to treat benign prostatic hyperplasia (BPH), improving urinary flow and reducing prostate-related discomfort. Available in 4mg and 8mg capsules

Product Description:

Silodosin is a selective alpha-1A adrenoceptor blocker used to relieve the urinary symptoms of benign prostatic hyperplasia (BPH) in men. Because it acts mainly on receptors in the prostate, bladder neck and urethra, it is less likely than non-selective alpha-blockers to cause blood-pressure side effects such as dizziness on standing, although abnormal or retrograde ejaculation is very common. It was discovered by Kissei Pharmaceutical in Japan and is sold as Rapaflo in the US and as Urorec or Silodyx in Europe. In the US and EU the usual dose is one 8 mg capsule daily with food, or 4 mg in moderate kidney impairment.

Silodosin manufacturing in India

Generic silodosin is widely made and sold in India and many other markets, and Indian manufacturers produce it both as API and as 4 mg and 8 mg capsules.

When sourcing silodosin API, ask for:

• Enantiomeric purity. Silodosin is a single enantiomer, so the specification should control the unwanted isomer.
• Grade and documents. A Certificate of Analysis to the pharmacopoeia or specification your registration uses, a DMF or CEP where your market needs one, and the site's GMP certificate.
• A nitrosamine risk assessment, which most regulators now expect for every API.

For capsules, confirm the strength, pack and registration status in your market. Our explainers on the Drug Master File and the Certificate of Analysis cover the documents in more detail, and our capsule contract manufacturing page covers own-brand supply. Send us an RFQ with the form, quantity and destination market.