Bhisaj Pharma: Bolstering The Api Industry With Quality Research, Development, & Innovation

Swapnil Sonawane Ph D, Managing Director

Swapnil Sonawane Ph D

Managing Director

Claimed to be the third largest producer of Active Pharma Ingredients (API), India is witnessing significant growth in the API market, with the momentum fueled partially by the COVID-19 outbreak and largely by the enforcement of government policies. According to a recent report by Mordor Intelligence, the industry is poised to grow at a CAGR of 8.3 percent and reach a value of around $ 18.76 billion by 2028. The developing industry is also complimented by the influx of API manufacturers. However, the rising competition has made it challenging for the pharmaceutical companies to handpick credible API manufacturers, who are distinguished by their emphasis on innovation, research and development, cost-effectiveness, and, most importantly, the quality of the products. If you are also on the radar for such ventures, look no further than Bhisaj Pharma. Proactive in fulfilling its motto of leveraging green chemistry for better living, the Pune-based pharmaceutical solution provider stands as the epitome of all the aforementioned factors.

Bhisaj Pharma, which started as a small setup, has now evolved into a prominent startup with a turnover of more than 150 million with the help of its strategic business partners across various geographic locations. Incorporated to reinforce the pharmaceutical industry with quality solutions, the company specializes in the manufacturing of advanced complex regulatory materials and API's securing IP. Founded as the collective endeavor of three experts in the field of pharmaceuticals – Dr Swapnil Sonawane, Ms Nilima Sonawane, and Dr. Sagar Nehate - the 2-year-old venture, is recognized for various revolutionary changes, including being the only company in India to provide advanced intermediates for synthesizing one of the key API, Lumateperone tosylate.

“Our company officially started its operations during the early onset of the pandemic, which exerted a lot of restrictions on the supply chain management. But we regarded this as an opportunity and forayed into the market with a focus on providing novel solutions for the realm of advanced intermediates, which was fraught with IP and regulatory challenges,” explains Dr Swapnil Sonawane, Managing Director, Bhisaj Pharma. The suite of API and intermediate services aims to offer antibacterial, antineoplastic, antidiabetic, bile acids, and other drugs. Along with supplying advanced intermediates for manufacturing, Bhisaj Pharma has also carved a niche in leveraging end-to-end development and manufacturing of intermediates, APIs, and NCEs, right from identifying the molecule to due diligence to IP evaluation to product transfer to the customers.

With such an R&D center powering its operations, Bhisaj Pharma helps customers build and make their patent portfolios cost competitive and IPresilient

Swapnil Sonawane Ph D, Managing Director

Enabling Robust R&D

Steered by a robust scientific advisory committee comprising scientists who work towards the shared goal of uplifting green chemistry principles, Bhisaj Pharma serves as a platform for customers’ contract research, development, and manufacturing (CDMO) projects in crop sciences, pharmaceutical, oncology, and medicinal chemistry. The company owns two cutting-edge research and development (R&D) labs at AIC-SEED Pune, while its association for biocatalysis with the IICT-CSIR institute adds an edge. Located in one of the reputed CSIR institute IISER, Pune, the AIC-SEED endows well-equipped instruments and facilities designed to deliver the desired quality and multiple functions. Bhisaj Pharma also offers R&D services to its regular customers and strives to optimize the process through route scouting and the selection of new synthetic routes.

“I am greatly thankful to the AIC-SEED Pune for the modern infrastructure and opportunities to research and develop. I am also grateful to Dr. S. Sivaram, the Director of AIC-SEED, honorary professor & INSA Sr. Scientist at IISER Pune, and my PhD guide, Dr. Mukund K. Gurjar for being the inspiration for our research,” proclaims Swapnil. Thanks to AIC SEED, providing such a fully equipped R&D center. Powering its operations, Bhisaj Pharma helps customers build a cost-competitive and IP-resilient patented portfolio, thereby enhancing product sustainability in the market.

“We always strive to respect and understand the needs of the customers, the product, and the respective market before initiating the process. “Employing a quality-by-design approach, we are committed to facilitating a long-term, affordable system of solutions. Instead of being a traditional business, we take a smarter way of designing to reduce manual consumption and augment the quality outcome,” shares Swapnil. Not just the ability to run different types of reactions, but the adept team can also synthesize various complex pharmaceutical materials and support API scale up from grams to kilograms based on ICH 11 guidelines. Built by using eco-friendly chemicals, the products further undergo the process of commercialization.

“We have our own small manufacturing unit set up nearby dedicated to commercialization,” says Swapnil. Backed by various GMP strategic business partners, the integrated company is wellequipped to understand and manage different technologies and drug lifecycles. The company also ensures timely delivery without compromising quality or the standard regulations and procedures that affect GMP and DMF filing. Moving forward, the company seeks to expand its product suite to include the coagulation segment while continuing to breathe life into its mission of building a healthier tomorrow.

Dr. Swapnil Sonawane, Managing Director

Having studied under a noted scientist, Dr. Mukund K. Gurjar, to pursue his Ph.D., Swapnil brings in more than two decades of pharmaceutical experience. Over his career, Swapnil has held diverse leadership roles in a multitude of eminent Indian as well as multinational API companies like Dr. Reddy’s Laboratories, Piramal Enterprises Limited, and UQUIFA. He has also actively contributed to the business and operations of sites, which exemplifies his deep prowess in process research, R&D, and technology transfer. Along with Bhisaj Pharma, he has also founded another venture named Bioxera Pharma Research LLP.

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