Introduction
Tadalafil Hydrochloride raw powder — widely known as the active pharmaceutical ingredient (API) of Cialis® — is a leading PDE5 inhibitor used globally for the treatment of erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (PAH).
Since the expiry of its original patents, generic Tadalafil raw powder has become one of the most sought-after APIs in international markets. Sourced primarily from China, India, and regulated Western suppliers, it is available in both bulk API form for manufacturing and research-grade lots for R&D.
This guide is designed for:
- Pharmaceutical manufacturers scaling Cialis® generics
- Wholesalers and distributors sourcing bulk PDE5 inhibitors
- Compounding pharmacies formulating customized ED/BPH therapies
- Research labs exploring novel formulations and PK/PD studies
👉 For direct sourcing, see Buy Tadalafil Powder Online: Verified Sources & Compliance.
What is Tadalafil Raw Powder?
- Chemical Name: Tadalafil
- CAS Number: 171596-29-5
- Molecular Formula: C22H19N3O4
- Molecular Weight: ~389.4 g/mol
- Appearance: White to off-white crystalline powder
- Solubility: Practically insoluble in water; soluble in DMSO and ethanol
- Stability: Stable under 2–8°C, dry, protected from light and humidity
Pharmacology
- Tadalafil inhibits the phosphodiesterase type 5 (PDE5) enzyme, preventing the breakdown of cGMP.
- Increased cGMP promotes smooth muscle relaxation in blood vessels, leading to improved blood flow.
- Its half-life (~17.5 hours) is significantly longer than Sildenafil (~4–5 hours), giving rise to the nickname “the weekend pill.”
Approved Indications
- Erectile Dysfunction (ED): Standard 10–20 mg doses as needed.
- Benign Prostatic Hyperplasia (BPH): Daily low-dose (2.5–5 mg).
- Pulmonary Arterial Hypertension (PAH): Marketed as Adcirca® (40 mg/day).
Pharmaceutical & Research Applications
- Erectile Dysfunction (ED)
- Tadalafil’s long half-life (17.5 hours) allows extended effect.
- Competitive advantage over Sildenafil: daily dosing option and longer activity window.
- Benign Prostatic Hyperplasia (BPH)
- Once-daily low-dose Tadalafil helps relieve urinary symptoms linked to prostate enlargement.
- Unique among PDE5 inhibitors in securing dual FDA approval for ED + BPH.
- Pulmonary Arterial Hypertension (PAH)
- Tadalafil improves exercise capacity and delays disease progression in PAH patients.
- Sold under the brand name Adcirca®.
- Formulation Development & Research
- Used in compounding pharmacies to create custom doses.
- Investigated for ODTs (orally disintegrating tablets), films, and liquid suspensions.
- Important comparator in PDE5 inhibitor pharmacological studies.
👉 For lab applications, see Research-Grade Tadalafil Powder: Applications in ED, BPH & PAH Studies.
Forms of Supply
Tadalafil is supplied in multiple forms across the pharmaceutical supply chain:
- Raw Tadalafil Powder (API)
- White/off-white crystalline API.
- Supplied in bulk drums (25 kg) with foil bags.
- Standard form for generic Cialis® production.
- Tadalafil Citrate Powder
- A salt form offered by some factories.
- More soluble in certain solvents, but less common than pure base API.
- Research-Grade Tadalafil Powder (RUO)
- Sold in 100 g–1 kg packs.
- Labelled For Research Use Only.
- Used by labs and CROs for formulation development, PK/PD trials, and preclinical studies.
- Finished Dosage (Tablets, Capsules, Films)
- Branded (Cialis®, Adcirca®) and generic versions.
- Supplied in fixed 2.5, 5, 10, and 20 mg doses for ED/BPH; 40 mg for PAH.
👉 For comparison, see Tadalafil Powder vs Finished Cialis Tablets: Cost & Flexibility.
Global Market Overview (2025)
The global PDE5 inhibitor market is valued at over $6.5 billion USD in 2025, with Tadalafil holding a strong share due to its dual approval (ED + BPH) and long half-life.
Key Regional Insights:
- China: Largest producer/exporter of raw Tadalafil API. Pricing advantage but variable quality.
- India: WHO-GMP and FDA-audited plants; stronger compliance, slightly higher costs.
- US/EU: No API production at scale; instead, distributors resell small RUO lots at high markups.
Patent Landscape:
- Major patents expired (2017–2020).
- Global expansion of Cialis® generics has fueled API demand.
Growth Drivers:
- Rising ED prevalence: affects ~1 in 3 men over 40 worldwide.
- Increasing use of daily low-dose Cialis® for BPH.
- Expanding adoption of Adcirca® (Tadalafil) for PAH.
- Greater acceptance of compounding pharmacies for customized ED therapy.
Quality Standards & Testing
Before purchase, buyers should verify that Tadalafil API meets USP/EP/ICH standards:
Specifications:
- Purity: ≥99% by HPLC.
- Related Substances: ≤0.5% total impurities.
- Loss on Drying: ≤0.5%.
- Heavy Metals: ≤10 ppm.
- Residual Solvents: Within ICH Q3C guidelines.
Required Documents:
- COA (Certificate of Analysis).
- GMP Certificate.
- MSDS (Material Safety Data Sheet).
- DMF/CEP filings (for FDA/EMA-regulated imports).
Testing Methods:
- HPLC: Confirms purity and assay.
- NMR/IR: Confirms identity.
- Residual Solvent Analysis: GC/MS per ICH guidelines.
- Particle Size Testing: Required for micronized APIs.
👉 Detailed protocols in How to Check Tadalafil Powder Quality: USP Standards, COA & HPLC.
Pricing Benchmarks & Trends (2025)
Global Price Ranges:
| Region | Small Lot (1–5 kg) | Bulk (25+ kg) | Annual Contract (500+ kg) | Notes |
|---|---|---|---|---|
| China | $650–$900/kg | $350–$500/kg | $280–$350/kg | Lowest cost, flexible MOQ |
| India | $700–$950/kg | $400–$600/kg | $350–$450/kg | GMP, DMF-ready, slower delivery |
| US/EU | $1000–$1500/kg | $800–$1100/kg | $650–$850/kg | Research grade, small-lot only |
Cost Drivers:
- MOQ: Small lots cost 2–3x more than 25 kg drums.
- Compliance: DMF/CEP adds $2–5/kg.
- Purity: Micronized & USP-compliant batches cost more.
- Logistics: Air freight adds $20–30/kg; sea freight reduces cost but slower.
⚠️ Buyer Warning: Sub-$280/kg offers are almost always counterfeit or adulterated.
👉 For detailed trends, see Tadalafil Powder Price Analysis 2025.
Supplier Landscape (2025)
1. China Factories
- Advantages: Lowest per-kilo cost ($350–$500/kg bulk), flexible MOQs (as low as 5–10 kg), fast production lead times (1–2 weeks).
- Weaknesses: Variable quality, some exporters act as traders not true factories, counterfeit risks if priced < $280/kg.
- Best For: Cost-sensitive buyers who can run independent third-party testing (HPLC/NMR).
2. India API Plants
- Advantages: WHO-GMP, FDA-audited facilities; DMF/CEP documentation available; strong credibility in regulated imports.
- Weaknesses: Higher base cost ($400–$600/kg bulk), MOQ typically 25+ kg, slower turnaround (4–6 weeks).
- Best For: Buyers in regulated markets (US/EU) requiring strict compliance files.
3. US/EU Distributors
- Advantages: Easy access, fast domestic delivery, strong oversight for research-grade supply.
- Weaknesses: Prices are 2–3x higher than Asia ($800–$1,200/kg), limited to 1–5 kg lots, not scalable for manufacturing.
- Best For: Labs, CROs, compounding pharmacies needing small RUO packs.
MSDS & Safety Guidelines
Hazard Identification (GHS Classification):
- Mild irritant to eyes/skin/respiratory system.
- Harmful if ingested in uncontrolled/raw form.
- Not classified as carcinogenic.
Safe Handling:
- PPE: gloves, goggles, dust mask/respirator, lab coat.
- Work in fume hood or ventilated space.
- Avoid dust formation, use calibrated scoops.
Storage:
- Keep sealed in foil bags inside fiber drums.
- Store at 2–8°C, away from light, moisture, and heat.
- Shelf life: 24–36 months under correct conditions.
Transport:
- HS Code: 29339990.
- Not classified as dangerous under IATA/IMDG, but must ship with COA + MSDS.
👉 Full protocols: Tadalafil Powder MSDS & Handling Guidelines.
Buyer’s Checklist
Before finalizing a Tadalafil powder order, confirm:
- Essential Documents
- COA (batch number, HPLC purity ≥99%).
- GMP Certificate.
- MSDS.
- DMF/CEP (for regulated imports).
- Testing & QA
- Run independent HPLC/NMR.
- Confirm residual solvents & heavy metals.
- Check particle size if micronized powder required.
- Negotiation Tips
- Start with 1–5 kg pilot lot.
- Secure tiered pricing (25 kg, 100 kg, 500+ kg).
- Lock annual contracts for stable supply and 10–20% discounts.
- Red Flags
- Price quotes below $280/kg bulk.
- No GMP/MSDS offered upfront.
- Packaging not double-sealed.
- COA without batch number.
Conclusion & Next Steps
Tadalafil raw powder is a cornerstone PDE5 inhibitor API for ED, BPH, and PAH formulations, with strong demand in both pharma and research.
Key Takeaways:
- China = lowest cost; India = compliance-driven; US/EU = small-lot supply.
- Prices: $350–$500/kg bulk in Asia; $800–$1,200/kg small lots in US/EU.
- Always demand COA, GMP, MSDS, DMF/CEP.
- Start small → verify → scale contracts.
📌 Next Steps:
- Entry-level sourcing
- Bulk scaling
- Factory vetting
- Compliance & safety
By combining cost efficiency, compliance documentation, and rigorous testing, buyers can build a safe, profitable, and long-term Tadalafil supply chain in 2025 and beyond.