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Pirfenidone API

Name of Product Perfinidone
CAS No 53179-13-8
Therapeutic use:- Anti‑Inflammatory
Grade BP/USP
Form:- API Powder
Status Commercial

Product Overview

Pirfenidone API is a small, synthetic Active Pharmaceutical Ingredient.

It has a clear chemical structure and a reliable quality profile.

It is supplied for use in solid oral dosage formulations such as tablets and capsules.

The API is made with strict quality systems. It meets key pharmacopeial standards and supports global drug markets.

Therapeutic Applications

Pirfenidone API is used to create finished products.

It works well for solid oral products that need consistent quality and stability.

The API aids formulation development in regulated markets.

It’s designed for research, scale-up, and commercial manufacturing.

All of these meet approved pharmaceutical standards.

Specification Parameters

Pirfenidone API specifications show their identity. They also detail purity and quality needs.

These are crucial for steady drug production.

  • Chemical Name (IUPAC): 5-Methyl-1-phenyl-2-(1H)-pyridone

  • CAS Number: 53179-13-8

  • Molecular Formula: C₁₂H₁₁NO

  • Molecular Weight: 185.22 g/mol

  • Appearance: White to off-white crystalline powder

  • Identification Tests: IR Spectrum, HPLC Retention Time

  • Assay Method: HPLC (on dried basis)

  • Related Substances / Impurities: Controlled by HPLC limits

  • Residual Solvents: As per ICH Q3C requirements.

  • Elemental Impurities: Complies with ICH Q3D guidelines.

  • Loss on Drying / Water Content: Within specified limits

  • Residue on Ignition: Meets pharmacopeial limits

  • Microbial Limits: Not applicable for API grade.

  • Polymorphic Form: Stable crystalline form

      Packaging & Storage

      Pirfenidone API in bulk is packed inside HDPE or fiber drums for safe handling.

      The API is carefully stored in a cool, dry space, away from light and moisture.

      Containers are kept tightly closed to ensure top-notch quality.

      Why Choose Us

      Actiza Pharmaceutical Pvt. Ltd. is a trusted Indian maker of APIs. They consistently provide high-quality Pirfenidone API.

      Quality Focus

      Our Pirfenidone API is made with strict processes and tested at each stage.

      This provides stable quality and high purity. It also meets key international pharmacopeial standards.

      Certified Systems

      We’re WHO-GMP certified, which means our facilities follow strict quality systems.

      This gives us a strong base. It helps with manufacturing, documentation, and meeting global regulatory standards.

      Modern Facilities

      Our manufacturing units use advanced equipment and automated systems.

      Dedicated production areas boost efficiency. They lower cross-contamination risks.

      They also ensure that each batch maintains consistent quality.

      Reliable Supply

      We handle everything in-house, so deliveries are always on time and supplies keep coming.

      We plan carefully and manage logistics to keep our partnerships running smoothly and our API available 24/7.