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Dutasteride Structure

Product Type

API

Grade

BP/USP

Chemical Formula

C27H30F6N2O2

IUPAC Name

(5α,17β)-N-{2,5-bis(trifluoromethyl)phenyl}-3-oxo-4-azaandrost-1-ene-17-carboxamide

CAS No.

164656-23-9

Molecular Weight

528.53 g/mol

Chemical Class

Steroid derivatives

Therapeutic Class

Anti-BPH

Synonyms

PHYSIOCHEMICAL PROPERTIES

Appearance Off-White Crystalline Solid
Solubility Highly soluble in DMSO
Melting point 242–250 °C
pH Less than 2

Product Description

Dutasteride is a synthetic 4-azasteroid compound that selectively inhibits both the type I and type II isoforms of steroid 5α-reductase, an intracellular enzyme that converts testosterone to 5α-dihydrotestosterone (DHT). Dutasteride works by reducing the levels of circulating DHT. It was also shown to reduce the size of the prostate gland, improve urinary flow, and symptoms of benign prostatic hyperplasia alone or in combination with tamsulosin.

How Dutasteride Works

Dutasteride works by inhibiting both type I and type II isoforms of the enzyme 5-alpha reductase, which converts testosterone into dihydrotestosterone (DHT), a hormone that plays a key role in prostate growth and hair loss. By significantly reducing DHT levels in the blood and tissues (by over 90%), dutasteride helps shrink an enlarged prostate in men with benign prostatic hyperplasia (BPH), improving urinary flow and symptoms. It may also slow or prevent hair loss by reducing DHT activity in hair follicles, although this use is considered off-label in some regions.

Use(s)

Adverse Effects

Why choose Salius for Dutasteride?

  1. WHO-GMP Certified Manufacturing
    Salius Pharma produces Dutasteride in facilities certified by the World Health Organization’s Good Manufacturing Practices (WHO-GMP), ensuring the API meets high-quality, safety, and purity standards required globally.
  2. Consistent Quality and Reliability
    They maintain strict quality control protocols to provide consistent, pharmaceutical-grade Dutasteride. This reliability helps pharmaceutical companies avoid batch failures and regulatory issues.
  3. Global Export Experience & Documentation Support
    Salius regularly exports APIs, provides regulatory documents (DMF, impurity profiles), and supports filings for international clients—even in stringent regulated markets
  4. Documents We Provide
  5. Focus on Chronic Therapy APIs
    Salius specializes in APIs for chronic diseases, demonstrating expertise in producing reliable compounds like Dutasteride, often used in long-term treatments.
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO GMP, ISO 9001:2015, FDA audited facilities
Affordability & Generic Access Cost competitive generics for global supply
Export Experience Proven track record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

Dutasteride API is the pure, active pharmaceutical ingredient used to formulate medications for treating benign prostatic hyperplasia (BPH) and, off-label, male pattern baldness.

Dutasteride inhibits type I and type II 5-alpha reductase enzymes, reducing the conversion of testosterone to dihydrotestosterone (DHT), a hormone linked to prostate growth and hair loss.

No, it is not recommended for women, especially those who are or may become pregnant, due to the risk of fetal harm.

Serum testosterone levels may increase slightly (10–20%) due to feedback inhibition after DHT reduction, but it usually remains within the normal range.

Yes, Salius Pharma exports Dutasteride API to several African countries, including Nigeria, Kenya, South Africa, Egypt, Ghana, Tanzania, Uganda, Ethiopia, Morocco, and Algeria. Their broad export network and certifications (WHO-GMP, USFDA, UK MHRA) support their presence across these regions in Africa.

Place an Order or Request a Quote

Looking to source Dutasteride or other high-quality pharmaceutical products? We’re here to help. Whether you need Active Pharmaceutical Ingredients (APIs), finished formulations, or regulatory support, our team is ready to provide dependable, compliant, and cost-effective solutions tailored to your market needs.

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