Tadalafil（171596-29-5）

1. Product Basic Information

Product Name: TadalafilCAS Number: 171596-29-5Molecular Formula: C₂₂H₁₉N₃O₄Molecular Weight: 389.40Chemical Name: (6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':4,5]pyrrolo[3,4-b]indole-1,4-dioneAppearance: White to off-white crystalline powder, odorlessSolubility: Practically insoluble in water, slightly soluble in ethanol, soluble in DMSO, dichloromethaneMelting Point: 296–300°CPurity: 98%, 99%, customizableStorage: Sealed, protected from light, stored in cool and dry area

Tadalafil is a highly selective, reversible, long-acting phosphodiesterase type 5 (PDE5) inhibitor. It is a first-line API for the treatment of male erectile dysfunction (ED) and for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH) in men with ED. Compared with similar drugs, Tadalafil features fast onset, long duration (up to 36 hours), no interference by food or alcohol, high safety and good tolerance. It has become one of the most widely used and recognized APIs in andrology.

Shaanxi Cuikang Pharmaceutical Technology Co., Ltd. specializes in R&D, production and sales of high-end pharmaceutical APIs and intermediates. With mature synthetic processes, strict quality control and large-scale production capacity, we provide high-purity, high-quality and stable Tadalafil for global pharmaceutical enterprises.

2. Mechanism of Action

Tadalafil acts through highly selective inhibition of PDE5 with a clear mechanism:Under sexual stimulation, nitric oxide (NO) is released in the corpus cavernosum, activating guanylate cyclase and increasing cyclic guanosine monophosphate (cGMP). This relaxes smooth muscle and increases blood flow, leading to erection.

PDE5 degrades cGMP rapidly and weakens erection. Tadalafil selectively inhibits PDE5 to reduce cGMP breakdown, prolonging and enhancing the erectile response, helping patients achieve and maintain effective erection.

Tadalafil shows high selectivity for PDE5 and weak inhibition on other PDE isoenzymes (PDE1, PDE2, PDE3, PDE4, etc.), resulting in minimal cardiovascular effects and excellent safety. Its long half-life provides a 36-hour therapeutic window for flexible use.

3. Core Advantages

1. High selectivity & excellent safetyHighly specific to PDE5; mild and transient side effects; higher safety than similar products.

2. Long-acting & flexible dosingLasts up to 36 hours, much longer than sildenafil or vardenafil.

3. No interference by food or alcoholHigh-fat meals and moderate alcohol do not affect absorption or efficacy.

4. Rapid onset & stable effectAbsorbs quickly; effective in 15–30 minutes with reliable performance.

5. Dual indication benefitTreats ED and improves lower urinary tract symptoms (LUTS) in BPH patients.

6. High purity, low impurities & great stabilityPurity ≥99%; strict control of impurities, heavy metals and residual solvents.

4. Indications & Clinical Applications

1. Treatment of male erectile dysfunction (ED)

Effective for organic, psychogenic and mixed ED; helps restore normal erectile function.

2. Treatment of ED with benign prostatic hyperplasia (BPH)

Improves LUTS (frequency, urgency, weak stream, nocturia) and erectile function.

3. Treatment of pulmonary hypertension (PH)

Used for pulmonary arterial hypertension to improve exercise capacity and quality of life (under medical guidance).

5. Production & Quality Advantages

We operate under GMP-like standards with full-process quality control:

1. Advanced synthetic routeHigh yield, low impurity, eco-friendly process with stable crystal form.

2. Strict quality testingAppearance, melting point, optical rotation, HPLC purity, related substances, heavy metals, residual solvents and microbial limits.

3. Stable large-scale supplyConsistent batches from gram to kilogram and 100-kilogram scale.

4. Full technical supportCOA, HPLC, MS, NMR and complete documentation for registration and audit.

6. Application & Market Position

Tadalafil is the largest, fastest-growing, first-choice PDE5 inhibitor API worldwide, widely used in:

• Oral tablets, orally disintegrating tablets, dispersible tablets

• First-line clinical andrology drugs

• Urology, endocrinology and cardiovascular combination therapy

• Global mainstream ED treatment drugs

With long-acting, safe and convenient advantages, Tadalafil is increasingly preferred in global markets.

7. Storage, Packaging & Transportation

• Storage: Sealed, dry, cool, away from light, acids and oxidizers

• Packaging: 1kg/bag, 5kg/drum, 25kg/drum, customizable

• Transport: Normal chemical transport; moisture-proof, light-proof

• Shelf Life: 24 months under proper storage

8. Summary

Tadalafil is a potent, safe, long-acting and highly selective PDE5 inhibitor, serving as a core API for male erectile dysfunction with great clinical value and market potential.

Based on advanced technology, strict quality control, stable production and professional service, Shaanxi Cuikang Pharma provides high-quality Tadalafil to global partners and is your reliable long-term supplier.