In pharmaceutical manufacturing, even a few microns can determine whether an API batch is approved or rejected. Particle size is not a minor technical detail, it is a critical quality attribute that directly influences stability, dissolution behaviour, and overall therapeutic performance. At Coral Drugs, particle-size precision is a core focus, because consistency at the microscopic level translates into confidence at the regulatory and formulation levels.

Uncontrolled particle size can create significant challenges, particularly in sensitive APIs such as Formoterol Fumarate and Salmeterol Xinafoate. Variations can lead to stability issues, poor dissolution performance, and loss of intended API activity. These risks not only affect product efficacy but can also result in regulatory observations or batch rejections. Recognising this, Coral Drugs adopts a science-led, data-driven approach to ensure tight particle-size control throughout the product lifecycle.

Our Chemical R&D and Analytical R&D teams work in close coordination to define, validate, and reproduce particle-size specifications. Using advanced analytical techniques and robust process controls, we ensure that each batch consistently meets defined targets. This level of precision supports reliable performance in the final formulation and enables smooth compliance with stringent global regulatory expectations.

Consistent particle-size control also plays a vital role in maintaining batch-to-batch uniformity. By embedding reproducibility into our manufacturing systems, we deliver APIs that perform predictably across markets, applications, and audit environments. The result is greater confidence for our partners and reduced risk during formulation and scale-up.

At Coral Drugs, precision in particle sizing means confidence in every API. It is how we align scientific accuracy with regulatory compliance to deliver stable, reliable, and globally trusted APIs.

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