Tadalafil — API | CAS 171596-29-5

TCS Industries Limited (China-sourced API supplier) supplies Tadalafil — API CAS 171596-29-5 for pharmaceutical B2B procurement — COA, MSDS, and technical documentation available on request.

> Overview

Product Name Tadalafil
Structural Formula Tadalafil CAS 171596-29-5 structural formula
CAS Number 171596-29-5
Molecular Formula C22H19N3O4
Molecular Weight 389.4 g/mol
InChIKey WOXKDUGGOYFFRN-IIBYNOLFSA-N
SMILES Available on request where applicable
Appearance White to off-white crystalline powder
Purity / Grade By agreed specification and batch COA
Storage Room temperature, protect from moisture

Tadalafil (CAS 171596-29-5) is a PDE5 inhibitor with the formula C₂₂H₁₉N₃O₄ (MW 389.40). It selectively inhibits phosphodiesterase type 5 (PDE5), increasing cyclic guanosine monophosphate levels in smooth muscle and causing vasodilation. Tadalafil is used for erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension.

TCS Industries Limited, a Hong Kong-based trading and sourcing company, supplies Tadalafil API in pharmaceutical grade for global procurement programs.

> Applications

Erectile dysfunction and BPH

Tadalafil 5–20 mg is used for erectile dysfunction (on-demand 10–20 mg or daily 2.5–5 mg). Its uniquely long duration of action (up to 36 hours, half-life ~17.5 hours) distinguishes it from sildenafil and vardenafil. Daily 5 mg dosing is also FDA-approved for BPH symptoms. Brock et al. (J Urol, 2002, 168:1332–1336) demonstrated the efficacy of tadalafil across all severity levels of erectile dysfunction with its prolonged duration of action enabling a wider treatment window.

Pulmonary arterial hypertension

Tadalafil 40 mg once daily (Adcirca) is approved for pulmonary arterial hypertension (PAH). PDE5 inhibition in pulmonary vasculature reduces pulmonary vascular resistance and improves exercise capacity. Tadalafil has the advantage of once-daily dosing for PAH (vs. sildenafil TID).

> Sourcing & Supply

TCS Industries Limited supports development, qualification and commercial purchasing discussions for Tadalafil with buyers in Australia, New Zealand, Canada and South Korea.

  • Evaluation and commercial quantities: 500 g samples for formulation development; 5 kg and 25 kg for production. Pharmaceutical (USP/Ph.Eur.) grade crystalline powder. DMF reference letters available.
  • Pallet quantities and production campaigns: repeat supply is coordinated against packaging, lead time, annual demand and destination-market import requirements.

> Quality & Documentation

Key specification parameters include assay (≥99.0%), related substances (individual ≤0.15%, total ≤0.5%), specific optical rotation, loss on drying, residual solvents, heavy metals, particle size distribution, and microbial limits. White to off-white crystalline powder. Practically insoluble in water, slightly soluble in ethanol. Identity by HPLC, IR, and specific optical rotation. Meets USP (Tadalafil) and Ph.Eur. COA and MSDS are standard.

> Packaging

Tadalafil is a white to off-white crystalline powder. Standard packaging includes double PE-lined foil bags in fibre drums (1 kg, 5 kg, or 25 kg). Store at controlled room temperature (15–25 °C). Protect from moisture. Shelf life is typically 36 months. Labels and documents are checked before dispatch.

> Pricing & MOQ

Pricing is quoted by specification, packaging and destination. Common commercial discussions use 25 kg bag/drum formats, pallet quantities and production-campaign planning; smaller samples may be reviewed for qualified formulation teams.

> Regulatory & Compounding Context

Tadalafil is monographed in USP and Ph.Eur. FDA-approved in 2003 (Cialis for ED, 5/10/20 mg) and 2009 (Adcirca for PAH, 40 mg). EMA-authorized. Off-patent in the US since 2018. Multiple generic approvals. Daily 5 mg dosing for BPH approved in 2011. DMF support available.

> Alias Index

  • INN: Tadalafil
  • CAS Number: 171596-29-5
  • Formula: C₂₂H₁₉N₃O₄ (MW 389.40)
  • Brand names: Cialis (ED/BPH), Adcirca (PAH)
  • ATC code: G04BE08
  • Commercial request terms: tadalafil API, Cialis generic, PDE5 inhibitor, pulmonary hypertension API, TCS Industries Limited

> FAQ

Why does Tadalafil last 36 hours?

Tadalafil has a half-life of ~17.5 hours (vs. ~4 hours for sildenafil). This is due to its methylenedioxyphenyl structure, which resists CYP3A4-mediated metabolism. The 36-hour clinical window eliminates the need for timed dosing around sexual activity, enabling both on-demand and daily dosing regimens.

What documents are available for Tadalafil orders?

COA and MSDS are standard for commercial discussions. COO, packing list, invoice and other import-support documents can be arranged according to order scope.

Do you supply Tadalafil to Australia and Canada?

Yes. We support B2B buyers in Australia, New Zealand, Canada and South Korea, subject to route and document review.

Do you supply New Zealand and South Korea?

Yes. We review Australia, New Zealand, Canada and South Korea for project supply, import documents, packaging and logistics planning before quotation.

Can Tadalafil be used daily?

Yes. Daily 2.5–5 mg tadalafil provides continuous PDE5 inhibition for both ED and BPH. This approach maintains steady-state drug levels, eliminates timing concerns, and provides concurrent BPH symptom relief. Daily dosing requires ~5 days to reach steady state.

How does the PAH dose differ from the ED dose?

PAH requires 40 mg once daily (Adcirca) — 2–8× higher than ED doses (5–20 mg). The higher dose is needed to achieve sustained pulmonary vasodilation throughout the 24-hour dosing interval. PAH patients need continuous hemodynamic improvement, not intermittent effect. Adcirca and Cialis tablets are not interchangeable.

Can you arrange samples before commercial purchasing?

Samples or evaluation quantities may be reviewed for qualified buyers after target specification, application and destination-market requirements are clarified.

How is Tadalafil packaged for export?

Packaging is confirmed by quantity and material properties. Typical options include foil bags, HDPE containers, fibre drums, 25 kg bags or palletized export packaging.

Can buyer-defined specifications be reviewed?

Yes. Send the specification, methods, impurity limits and required documents. TCS can review feasibility before confirming quotation and lead time.

What payment terms are normally used?

Standard payment is 100% T/T before dispatch unless a different arrangement has been approved for an established commercial account.

What lead time should buyers expect?

Lead time depends on stock, batch size, document scope and destination. Available stock can move faster; made-to-order or pallet programs require longer planning.

Is a DMF available?

Yes. TCS sources tadalafil from manufacturers who maintain active DMFs with the FDA and ASMF/CEP with EMA. Off-patent with extensive generic competition. COA, stability data, and DMF reference letters are provided for ANDA and generic dossier support.

Last reviewed: June 2026

Evaluation and research orders (≤10 kg) are shipped with COA, MSDS, and certificate of origin. Bulk commercial orders (>10 kg) qualify for volume pricing with a full technical documentation package available on request.

> Request a Quote

If your team already has a target application, estimated quantity, destination market, or documentation requirements, send those details so the commercial response can be prepared more efficiently.

Contact the Commercial Team

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