Premium Avanafil API in Pakistan: Advanced Raw Material for Pharmaceutical Formulators

Premium Avanafil API in Pakistan: Advanced Raw Material for Pharmaceutical Formulators

Product Name: Avanafil (Active Pharmaceutical Ingredient)

Brand/Supplier: Morgan

Therapeutic Category: Phosphodiesterase Type 5 (PDE5) Inhibitor

Indications: Erectile Dysfunction (ED)

Compliance Notice: This technical catalog is intended exclusively for B2B pharmaceutical manufacturers, contract manufacturing organizations (CMOs), and analytical laboratories. The Avanafil supplied by Morgan is a highly purified Active Pharmaceutical Ingredient (API) strictly for commercial formulation and R&D. It is not a finished medicine.

About Morgan: Morgan Chemicals (Pvt.) Ltd. is a pharmaceutical raw material trading and distribution company. We source APIs from DRAP-registered and internationally certified manufacturers and supply exclusively to licensed pharmaceutical companies, CMOs, and research facilities. We do not manufacture APIs or sell finished medicines.

Product Overview and Mechanism of Action

Avanafil is an orally active, highly selective Active Pharmaceutical Ingredient (API) classified as a phosphodiesterase type 5 (PDE5) inhibitor. In urological and reproductive pharmacology, it is utilized to address male erectile dysfunction (ED) by facilitating targeted vascular engorgement.

Unlike older generations of PDE5 inhibitors, Avanafil is distinguished by its rapid pharmacokinetic profile and exceptionally high receptor selectivity. It functions by competitively inhibiting the PDE5 enzyme, which is responsible for the degradation of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum. During sexual stimulation, local release of nitric oxide stimulates the synthesis of cGMP, leading to smooth muscle relaxation and increased inflow of blood into penile tissues.

By preventing cGMP degradation, Avanafil sustains smooth muscle relaxation and enhances the erectile response. Notably, Avanafil exhibits significantly higher selectivity for PDE5 over other phosphodiesterase isozymes (such as PDE1, PDE3, and PDE6) compared to legacy APIs like sildenafil or tadalafil. For formulation scientists, this translates to a finished drug profile with a drastically reduced incidence of systemic side effects, such as visual disturbances or cardiovascular hypotension. In finished dosage forms, this API is typically formulated as rapid-acting 50 mg, 100 mg, or 200 mg oral solid tablets.

Sourcing Avanafil Pakistan: Morgan’s Supply Network

For pharmaceutical formulation facilities in the region, relying on overseas API procurement can introduce variability in lead times and complicate regulatory approvals. Procuring Avanafil Pakistan through Morgan’s localized supply network provides distinct operational advantages for commercial manufacturing.

We supply pilot-scale and commercial-scale quantities synthesized in strict adherence to ICH Q7 Good Manufacturing Practice (GMP) guidelines for active pharmaceutical ingredients.

Partnering with Morgan provides your procurement and R&D teams with the following provisions:

• DRAP Registration Support: We supply comprehensive regulatory documentation, including the open parts of the Drug Master File (DMF), detailed impurity profiles, and accelerated stability data. This facilitates streamlined dossier submissions to the Drug Regulatory Authority of Pakistan (DRAP).
• Supply Chain Stability: By maintaining local API inventory, Morgan eliminates international transit delays and customs clearance variables, ensuring your commercial batch schedules are met without interruption.
• Batch-to-Batch Uniformity: Every delivery is accompanied by a verified Certificate of Analysis (CoA). We ensure strict adherence to specifications for chemical purity, moisture content, and particle size distribution (PSD), enabling predictable blending, direct compression, and film-coating behavior.

Technical Specifications for QA & R&D

The structural and chemical integrity of the active ingredient dictates the bioavailability, onset of action, and safety of the finished drug. Morgan’s Avanafil API is subject to rigorous analytical testing to meet international pharmacopeial standards.

• Chemical Name: (S)-4-(3-chloro-4-methoxybenzylamino)-2-[2-(hydroxymethyl)-1-pyrrolidinyl]-N-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide
• CAS Number: 330784-47-9
• Appearance: White to off-white crystalline solid powder
• Molecular Formula: C23H26ClN7O3
• Molecular Weight: 483.95 g/mol
• Assay / Purity (HPLC): ≥ 99.0%
• Solubility: Soluble in specific organic solvents; practically insoluble in water. Detailed solubility parameters across standard solvents and aqueous buffers are available in Morgan's technical data sheet to assist with dissolution profiling and bioavailability enhancement.

Manufacturing and Handling Guidelines

While Avanafil does not carry the severe teratogenic risks of some cardiovascular APIs, it remains a pharmacologically active compound that requires strict occupational exposure limits (OEL) during formulation.

• Storage Conditions: Store the raw API powder in well-closed, light-resistant containers. Maintain climate-controlled conditions as specified by the batch protocol (typically protected from extreme heat and excess humidity) to prevent chemical degradation.
• Occupational Safety: Manufacturing personnel handling the raw powder must adhere to standard active ingredient containment protocols. Processing requires appropriate Personal Protective Equipment (PPE), including P3/N95 industrial respirators, chemical-resistant nitrile gloves, and protective laboratory garments. Dispensing, milling, and granulation stages should be executed under localized exhaust ventilation or within containment isolators to prevent inhalation of airborne particulates and cross-contamination.

Distributor Disclaimer: Morgan Chemicals is a pharmaceutical raw material trading and distribution company. This API is sourced from DRAP-registered, GMP-certified manufacturing partners. Morgan Chemicals does not manufacture APIs, does not hold DRAP manufacturing registration, and does not sell finished medicines. This product is supplied exclusively to licensed pharmaceutical companies, CMOs, and research facilities in Pakistan — not for individual or consumer sale.