With adherence to stringent international regulatory guidelines, the new facility at Pithampur marks a significant leap in manufacturing capabilities with an annual capacity of 400 tonnes, catering to domestic and international supplies and in compliance with international quality standards.
Rusan Pharma, a leading pharmaceutical company committed to improving healthcare globally and pioneering pain management and addiction solutions worldwide – recently achieved a momentous milestone with the launch of its state-of-the-art API facility in Pithampur, Special Economic Zone (SEZ), Madhya Pradesh. This achievement represents Rusan Pharma’s unwavering commitment to addressing the alarming rise in pain management, drug, alcohol, and tobacco addiction while contributing to the growth of the Indian pharmaceutical industry.
With an approach to sustainable development and technological advancements, the total investment over two phases will be up to INR 300 crores, highlighting Rusan Pharma’s commitment to the pharmaceutical sector and its potential impact on the industry’s growth and development. The facility is designed to meet stringent international regulatory guidelines, ensuring the highest level of compliance. With the production capability of 400 metric tonnes of APIs annually, the facility significantly contributes to Rusan Pharma’s growth and expansion plans, diversifying its portfolio and expanding its reach in India and other markets.
Dr. Navin Saxena, Founder and Chairman – Rusan Pharma, said, “The new API facility in Pithampur, will enable Rusan to significantly enhance our existing API capacity and ensure the security of supply of critical APIs to meet the growing demand for our addiction treatment and pain management products in India and globally. Rusan has invested the last 30 years and pioneered in making the treatment of addiction acceptable and accessible. We firmly believe that access to quality healthcare is a right and not a privilege. Our goal is to ensure that everyone who seeks treatment for addiction and pain management can access it.”
Strategically situated within the Pithampur Special Economic Zone (SEZ), the new facility will capitalise on the support and subsidies provided by the Madhya Pradesh state government. This central location will streamline business operations and export processes through the dry port, making it an optimal choice for Rusan Pharma’s expansion plans. The facility’s location in a dedicated pharmaceutical zone ensures a cleaner environment, reducing the risk of pollution from other industries in the area.
Highlighting more about the initiative, Dr. Kunal Saxena – Managing Director, Rusan Pharma said, “At Rusan, we exemplify the ‘Make in India’ initiative, especially in the area of controlled substances. With an investment of about Rs. 300 crore in two phases, this new API facility will increase our current API manufacturing capacity from 40 metric tonnes in Ankleshwar to 400 metric tonnes in Pithampur. Our new plant boasts five modular API manufacturing blocks with dedicated suites for finished API manufacturing. This grants us complete control over the quality of our products and reduces our dependency on imports, aligning perfectly with our commitment to excellence. Incorporating advanced automation and compliant software will help us move towards paperless manufacturing, along with stringent environmental controls, which will enable us to produce essential medicines more affordably, expanding accessibility to a broader population.”
The facility in Pithampur sets itself apart with world-class automation, in-house design optimisation and a commitment to environmental controls, resulting in higher yields, reduced production costs, and top-notch product quality. Visually, the facility is an architectural marvel designed to withstand earthquakes and minimise disruption to the natural terrain. The facility’s unique feature includes an altitude difference between the ground floors of about 9 meters (3 floors), facilitating the flow of materials and supplies. Its eco-friendly and sustainable design minimises environmental impact while optimising the utilisation of natural resources. The architectural excellence of the facility also showcases robust elements ensuring operational efficiency and resilience. During the construction phase of the Pithampur facility, over 3000 contract workers were employed, and once it is fully operational, the facility will directly generate more than 300 employment opportunities, and over the years, more than 500+ indirect employment opportunities will be created.
Over the years and prior to this, Rusan Pharma has continuously diversified its portfolio. Besides manufacturing, the company has invested heavily in R&D to develop first-time, technologically advanced products. Rusan was the first company to introduce ‘Buprenorphine Sublingual and Buprenorphine Naloxone Sublingual Tablets’ for the treatment of drug abuse in India. Previously, the company had launched Apomorphine Injections for treating Parkinson’s. It also specialises in the category of transdermal patches and was the first company to launch indigenous formulations of Fentanyl, Buprenorphine, and Lidocaine transdermal patches for moderate to chronic pain and Nicotine transdermal patches for tobacco cessation. Rusan’s current GMP approvals for its APIs and finished formulations facilities have the potential to cater to 90% of the world’s demand. Some of the GMP approvals they are accredited with are Health Canada, TGA-Australia, SAPHRA-South Africa, EU, UAE, and Russia, to name a few.
Drug addiction, a global concern, has seen a significant impact with 296 million reported drug users worldwide in 2021, according to the UNODC World Drug Report 20231. In India, the issue persists with 23 million reported drug users in 2019, as reported by the Ministry of Social Justice and Empowerment (MOSJE) in the ‘Magnitude of Substance Abuse in India, 20192.
Shifting the focus to alcohol addiction, it is a pervasive global issue, with 2.35 billion3 people (43% of the global population) identified as current consumers of alcohol. The harmful use of alcohol led to 3 million deaths worldwide in 2016, as reported by the WHO Global Status Report on Alcohol and Health in 20184. While in India, 160 million people were identified in alcohol consumption, and a concerning 57 million Indians were reported to need assistance for alcohol use problems, according to MOSJE5.
Tobacco addiction, another critical health challenge, affects 1.3 billion individuals globally. The devastating consequences include more than 8 million deaths annually, with 1.3 million non-smokers succumbing to the effects of second-hand smoke, as reported by the World Health Organization (WHO)6. In India, a staggering 266.8 million adults were identified as current tobacco users in the Global Adult Tobacco Survey Report for India (2016-17)7.
