Rusan Pharma Ltd, a prominent player in the global pharmaceutical industry focusing on pain management and addiction treatment, has recently achieved two key certifications for its cutting-edge manufacturing hub located in the Kandla Special Economic Zone (SEZ)-UNIT-II in Gujarat, India.
Notably, the facility has been awarded the Good Manufacturing Practice (GMP) certification from the Australian Therapeutic Goods Administration (TGA) and attained an extension of the GMP status from Brazil’s ANVISA.
The TGA certification is a crucial milestone for Rusan Pharma as it seeks to penetrate the Australian market. Following a detailed inspection conducted earlier in the year, the GMP certification validates the production processes of the facility’s transdermal patches. These innovative drug delivery solutions are tailored to meet vital patient needs in addiction and pain management, advancing patient-centered therapeutic advancements.
Dr. Kunal Saxena, the managing director at Rusan Pharma Ltd., expressed his satisfaction, stating, “Our dedicated unit in Kandla SEZ (Unit II), Gujarat has been awarded A1 GMP certification by Australia’s TGA.
This marks the second approval following the TGA’s site inspection of our Kandla Unit-II facility. With this recognition, we are poised to launch our specialized products including buprenorphine, nicotine transdermal patches, and sublingual films designed for the Australian market. This achievement reflects our dedication to quality, innovation, and improved patient care through superior pharmaceutical solutions.”
Dr. Saxena further emphasized the significance of the GMP certification not only as a gateway to Australia but as a stepping stone in fortifying the company’s global export potential for niche formulations.
At the same time, the GMP extension from ANVISA corroborates Rusan Pharma’s solid standing in Brazil’s burgeoning pharmaceutical sector. This development paves the way for the company to enhance its offerings in Brazil, including products such as buprenorphine, donepezil, loxoprofen, and other essential patches.
“With the comprehensive ANVISA GMP clearances, including our active pharmaceutical ingredient (API) site certification, GCP approval for our clinical research organization – Quantys Clinical Pvt Ltd (QCPL), and the extended GMP status of our Kandla Unit-II for patches and films, Rusan is now a preferred partner for businesses seeking in-licensing opportunities for our niche products in Brazil and the broader LATAM market. This achievement underlines our unwavering commitment to delivering superior healthcare solutions in Brazil,” remarked Dr. Saxena.
These joint certifications—by TGA and ANVISA—highlight Rusan Pharma’s strategic goal of widening its global reach while adhering to regulatory excellence and fostering innovation. As Rusan Pharma progresses with strengthening its export prowess, these recognitions reinforce its commitment to being a trusted global healthcare partner, providing leading-edge solutions that elevate patient experiences and health outcomes.
Rusan Pharma stands as a fully integrated international pharmaceutical entity, specializing in addiction treatment and pain management. The company produces and distributes a comprehensive range of APIs and finished formulations, especially in the realm of controlled substances such as narcotic and psychotropic drugs.