Fenofibrate API: Specifications, Grades, and Global Export Requirements Table of Contents Fenofibrate is a widely prescribed
Blog
By riya
December 24, 2025
Fenofibrate API: Specifications, Grades, and Global Export Requirements
By riya
December 24, 2025
Fenofibrate API: Specifications, Grades, and Global Export Requirements
Table of Contents
Fenofibrate is a widely prescribed medication used to manage high cholesterol and triglyceride levels in the blood. Its active pharmaceutical ingredient (API) plays a critical role in the effectiveness of the final formulation, making quality control, proper specifications, and adherence to international standards essential. For pharmaceutical companies, suppliers, and exporters, understanding the nuances of Fenofibrate API is crucial to ensure safe and effective products reach the global market.
In this blog, we explore the key specifications, grades, and regulatory requirements involved in the production and export of Fenofibrate API. This guide is intended for manufacturers, distributors, and importers looking to make informed decisions when sourcing this important pharmaceutical ingredient.
Understanding Fenofibrate API
Fenofibrate API is the raw form of the active compound used in tablets, capsules, and other formulations aimed at controlling lipid levels. It belongs to the fibrate class of medications, which work by activating peroxisome proliferator-activated receptors (PPARs) in the liver. This activation increases the breakdown of triglycerides and promotes the production of high-density lipoprotein (HDL), also known as “good cholesterol.”
The quality and purity of Fenofibrate API are critical because they directly impact the effectiveness and safety of the medication. Even minor deviations in purity or particle size can affect bioavailability, stability, and patient outcomes. This is why sourcing from trusted manufacturers and adhering to strict specifications is a priority for pharmaceutical companies worldwide.
Specifications of Fenofibrate API
Fenofibrate API is evaluated against a series of rigorous specifications to ensure consistency, purity, and efficacy. These specifications include chemical identity, assay value, particle size, moisture content, and impurity limits. Each batch is tested through standardized analytical methods to confirm compliance with pharmacopoeia standards, such as the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP).
Chemical identity tests ensure that the API is indeed Fenofibrate and free from any adulterants or substitutions. The assay determines the precise percentage of active compound in the batch, which is typically required to be above 98% to meet regulatory and formulation standards. Impurity profiling is equally important, as it ensures that degradation products or residual solvents remain within acceptable limits. Moisture content and particle size are also carefully controlled to maintain the stability and uniformity of the final dosage form.
Grades of Fenofibrate API
Fenofibrate API is available in multiple grades, tailored to different pharmaceutical applications. These grades are primarily categorized based on purity, particle size, and suitability for specific formulations. Pharmaceutical companies often select a grade depending on the intended dosage form, whether tablets, capsules, or combination products.
High-purity grades are typically used for oral solid dosage forms, where consistency and uniformity are critical. Lower grades or technical grades may be used in formulations where API blending is required or where other excipients mask variations in particle size. Selecting the appropriate grade ensures optimal bioavailability, efficacy, and shelf life, making it a key consideration for manufacturers and suppliers.
Global Export Requirements
Exporting Fenofibrate API requires careful compliance with both national and international regulations. For Indian manufacturers and exporters, adherence to the Drug and Cosmetic Act, ISO certifications, and WHO-GMP standards is essential. International buyers also expect compliance with global pharmacopoeial standards, proper documentation, and validated analytical reports for each batch.
Countries importing Fenofibrate API often have additional regulatory requirements. For example, European countries may require a Certificate of Analysis (CoA) along with GMP compliance documentation. The United States typically requires FDA registration and adherence to USP standards. Proper labeling, packaging, and handling instructions are also mandatory to ensure the API maintains stability during transportation.
Logistics and storage are equally important. Fenofibrate API must be stored under controlled conditions to prevent moisture absorption, degradation, or contamination. Reliable exporters provide temperature-controlled shipping, tamper-proof packaging, and tracking solutions to guarantee that the API reaches its destination safely and in optimal condition.
Choosing the Right Fenofibrate API Partner
Sourcing Fenofibrate API from a reliable manufacturer or exporter is critical for ensuring quality, regulatory compliance, and timely delivery. Established companies with certified facilities, experienced R&D teams, and robust quality control protocols offer the best assurance of consistent product performance.
A good partner not only supplies high-quality API but also provides comprehensive documentation, including Certificates of Analysis, compliance certifications, and stability reports. They also offer guidance on selecting the correct grade and specifications based on the intended application. Working with such partners reduces the risk of regulatory issues, formulation failures, or supply chain disruptions.
Final Thoughts
Fenofibrate API is a vital component in managing cholesterol and triglyceride levels, and its quality determines the effectiveness of the final pharmaceutical product. Manufacturers, suppliers, and exporters must focus on strict adherence to specifications, selection of appropriate grades, and compliance with global export regulations.
Choosing the right partner in India ensures access to high-quality Fenofibrate API, timely delivery, and complete regulatory documentation. By prioritizing quality, compliance, and reliability, pharmaceutical companies can successfully deliver safe and effective products to patients worldwide.
FAQs
What is Fenofibrate API used for?
Fenofibrate API is used to manufacture medications that control high cholesterol and triglyceride levels in the blood.
How do specifications affect the API?
Specifications such as purity, particle size, moisture content, and impurities determine the stability, bioavailability, and efficacy of the final product.
Are there different grades of Fenofibrate API?
Yes, grades vary based on purity, particle size, and suitability for specific formulations. Choosing the right grade ensures optimal effectiveness.
What regulations apply to exporting Fenofibrate API?
Exporters must comply with local regulations like India’s Drug and Cosmetic Act, GMP standards, and international pharmacopoeia requirements, including FDA, USP, and EP standards where applicable.
Why is choosing the right partner important?
Reliable manufacturers and exporters ensure high-quality API, complete documentation, regulatory compliance, and timely delivery, reducing risks in the supply chain.