Tadalafil 171596-29-5 — China API Manufacturer | USP/EP/BP R&D to Production

China Manufacturing Landscape for Tadalafil

Tadalafil (CAS 171596-29-5) is a phosphodiesterase type 5 (PDE5) inhibitor used in the treatment of erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. As one of the highest-volume generic APIs globally, Tadalafil manufacturing in China has reached industrial maturity, with multiple quality-certified manufacturers operating dedicated production lines that collectively supply a significant share of the world’s generic Tadalafil API requirements. Our facility is a recognized leader in this category, with established supply relationships spanning pharmaceutical manufacturers in India, Southeast Asia, the Middle East, Africa, Latin America, and Europe.

The commercial scale of Tadalafil production in China has driven continuous process optimization, resulting in highly efficient synthetic routes, excellent solvent recovery rates, and production economics that no other manufacturing geography can match at equivalent quality levels. Our vertical integration extends from key starting material synthesis through final API production, eliminating dependencies on external intermediate suppliers and providing full traceability from raw materials to finished API.

Manufacturing Process & Facility

Tadalafil synthesis follows a well-established multi-step chemical route beginning with L-tryptophan as the chiral starting material, proceeding through Pictet-Spengler cyclization to form the tetrahydro-β-carboline core structure, followed by piperazinedione ring construction through coupling with chloroacetyl chloride and piperonal-derived intermediates. The stereochemical outcome of the Pictet-Spengler reaction is controlled through optimized reaction conditions and chiral induction from the L-tryptophan substrate, yielding the required (6R,12aR) stereochemistry with high diastereoselectivity.

Final purification involves recrystallization from validated solvent systems to achieve both the required purity and the correct polymorphic form. The manufacturing facility includes glass-lined and stainless steel reactors from 500 L to 6,000 L capacity, centrifugal filtration systems, vacuum dryers, and dedicated micronization equipment for particle size reduction to meet formulation requirements. The facility operates under NMPA certification with annual production capacity exceeding 50 metric tons of Tadalafil API.

Quality Standards & Multi-Pharmacopeial Compliance

Tadalafil manufactured at our facility meets USP, EP, and BP pharmacopeial specifications. HPLC purity consistently exceeds 99.5%, with individual specified impurities (including the (6S,12aR) diastereomer) controlled below 0.15% and total impurities below 0.5%. Chiral purity is verified by chiral HPLC to confirm >99.5% enantiomeric excess. Polymorphic form identity is confirmed by X-ray powder diffraction for every production batch to ensure consistent dissolution behavior in finished dosage forms.

Complete quality testing includes HPLC assay and related substances, chiral purity, polymorphic form by XRPD, residual solvents by headspace GC, elemental impurities by ICP-MS, water content, sulfated ash, particle size distribution by laser diffraction, and microbial limits. All methods are validated per ICH Q2(R1). Stability data under ICH Q1A conditions supports a 48-month retest period at room temperature storage.

Regulatory Documentation

Our Tadalafil regulatory package includes US FDA Type II Drug Master File, EU ASMF, and WHO Prequalification-compatible documentation. CTD Module 3.2.S documentation is maintained current with all post-approval variations incorporated. We provide genotoxic impurity assessment reports per ICH M7, nitrosamine risk evaluation documentation per regulatory authority guidance, elemental impurity risk assessment per ICH Q3D, and complete starting material justification packages. quality certificates, site master files, and inspection history documentation are available upon request, and we actively support customer regulatory filings with responsive technical queries handling.

Packaging & Logistics

Tadalafil API is packaged in double PE bag-lined fiber drums, with standard pack sizes of 5 kg, 10 kg, and 25 kg. Custom packaging configurations including HDPE containers for smaller quantities are available upon request. All packaging materials are qualified for long-term stability compatibility. Shipments are arranged via sea freight for bulk commercial orders (typical transit 20-35 days to destination ports) and air freight for development quantities or urgent orders (5-10 days). Complete export documentation including MSDS, CoA, phytosanitary certificates, and customs classification guidance is provided. DDP, CIF, FOB, and EXW Incoterms are supported.

Competitive Pricing & Supply Reliability

Our high-volume Tadalafil production platform delivers industry-leading pricing that direct customers consistently confirm as the most competitive available from any quality-certified source globally. Price quotations are provided on a per-kilogram basis with significant volume breaks at 100 kg, 500 kg, and 1,000 kg+ annual commitment levels. Lead times are typically 2-4 weeks for standard orders from maintained inventory, and 4-6 weeks for custom campaigns. We maintain rolling inventory of 3-5 metric tons to support immediate dispatch requirements, ensuring that our customers’ formulation schedules are never delayed by API availability constraints.

Tadalafil Specifications