Anurag Kumar

Managing Director

Rising healthcare needs, a growing population, and the increase in chronic diseases are driving the global market for finished pharmaceutical formulations (FDFs). Favorable regulations and government programs, such as ‘Make in India’ and the Greenfield PLI schemes, have driven India’s sector. The global market is growing at over 15 percent per annum, compared with double digits for India’s pharmaceutical market. However, companies have to deal with patents, strict quality standards, and regulatory requirements. Furthermore, to launch the product well within time, significant investments are necessary in clinical trials, bioequivalence studies, and quality control.

As a key player in the finished pharmaceutical formulation market, Biodeal Pharmaceuticals offers complete product development, clinical trial management, and regulatory compliance solutions. The company mainly focuses on making new molecules and all its products undergo rigorous clinical and bioequivalence trials as per the guidelines of the Drug Controller General of India (DCGI), and international regulatory bodies. These aspects also allow Biodeal to overcome patent restrictions and stringent quality expectations, allowing global and Indian pharma companies to launch new drugs in the market more easily.

Stringent Quality Control Measures

Biodeal Pharmaceuticals has a strong commitment to producing pharmaceuticals, nutraceuticals, and cosmetics of the highest quality, which is one of the biggest differentiators of the company. Even though testing is not always required on all active pharmaceutical ingredients (APIs) and excipients used in its products, it still insists on thorough quality control testing. For all formulations, the tests are done for stability to make sure that they meet or exceed industry standards, irrespective of whether they are in the food, cosmetics, or pharma category.

“The way we have collaborated with the top Indian pharmaceutical companies such as Cipla, Lupin, Sun Pharma, and Dr. Reddy's, among others, is testimony to our expertise in quality management. We continually improve our quality control systems and only work with industry leaders to ensure air handling, temperature control microbiological testing, and batch releases,” says Anurag Kumar, Managing Director, Biodeal Pharmaceuticals. The company's dedication to quality is also evident in its investment in a fully equipped R&D center dedicated to creating innovative formulations that will meet the market needs of both domestic and international markets.

Innovation in Drug Delivery Systems

Drug delivery systems are a key area of innovation in the ever-changing pharmaceutical landscape. Nasal sprays have emerged as a pioneer in the development of an alternative delivery system for medications that come in tablet or capsule form, and Biodeal Pharmaceuticals has been a pioneer in the development of nasal sprays. For conditions that need fast relief, such as severe pain, allergies, and epilepsy, the company has successfully developed a range of nasal sprays. For example, it has developed a high-potency painkiller in nasal spray form allowing it to be absorbed faster than traditional oral medications, resulting in rapid relief for the patient.

Other delivery systems, such as oral sprays for vitamins and sleep aids, have also been advanced by the company’s R&D team, which is especially useful for children or patients unable to swallow pills. In addition to developing a series of new, innovative products like a nasal spray for epilepsy to prevent fatalities from missed medication during attacks, Biodeal is also working to incorporate blockchain technology into the process of production, manufacturing, and distribution. These advances in drug delivery systems put Biodeal at the forefront of the development of the FDF market.

Comprehensive Research & Development Strategy

Biodeal Pharmaceuticals’ operations revolve around research and development (R&D). Its R&D focus is aligned with the global trends in the finished pharmaceutical formulation market, especially in the area of drug delivery innovations. It is actively working on developing products that patients find to be more convenient and effective, such as weekly vitamin D shots and oral sprays to replace multiple times daily doses.

One of Biodeal’s standout products from its R&D pipeline is a nicotine nasal spray aimed at helping smokers reduce their nicotine dependence without harming their respiratory system. Among other things, the company also has developed artificial saliva products to help people with cancer who are undergoing chemotherapy or those on dialysis who often have dry mouth as a side effect of treatment. These niche products are its commitment to solving unmet medical needs through innovative formulations.

Workforce Training & Safety Standards

The health and safety of its employees is paramount for Biodeal. The company holds regular training that focuses on safety, sanitization, and mental well-being so that its employees are completely ready for their responsibilities. For example, it practices quarterly safety weeks during which employees learn through workshops and quizzes on increasing workplace safety and hygiene standards tied in with the annual safety month.

Moreover, the company promotes a culture of continuous improvement, by giving employees ideas on how to improve safety and efficiency. As a proactive way to influence employee engagement, this boosts the morale of the workforce and elevates the manufacturing processes to the top of industry best practices.

Regulatory Accreditations & Global Expansion

Since its inception in 2007, Biodeal Pharmaceuticals has been accredited with many certifications related to Global Quality Standards. The company is a GMP-certified facility with PIC/S certification and can export to 27 countries. Furthermore, it is in the course of receiving accreditation from regulatory bodies in Brazil that will unlock the Latin American market.

Additionally, the company intends to grow its operations considerably in the years to come. Biodeal plans to complete the construction of a second, FDA-approved sterile manufacturing plant by 2026, which will allow it to serve regulated markets such as the U.S. and Europe. The expansion is in line with its effort to expand its footprint globally, and the company aims to export to more than 100 countries by 2026.

Ensuring Customer Satisfaction & Handling Feedback

Recognizing the need to ensure customer satisfaction, Biodeal Pharmaceuticals employs a strong pharmacovigilance system. This system helps the company track product performance in the market and manage issues before they become too big. It has not experienced complaints about product quality, but any logistical issues, like temperature control problems in transportation, are solved immediately.

Lastly, the company's focus on quality and customer satisfaction has enabled it to establish longstanding relationships with major pharmaceutical clients, all of which have further added to building the company's reputation as a reliable CDMO in the finished formulation space.

Future Roadmap & Strategic Initiatives

Biodeal Pharmaceuticals looks forward to growth and developing new products. It has become the first Indian company to launch a preservative-free nasal spray, which is on track to be launched soon. Furthermore, it is extending its ophthalmic product portfolio, and a new range of sterile eye care products will be launched by January 2025. These initiatives are being launched as part of its overall product diversification strategy in response to the changing requirements of the global pharmaceutical market.

In March 2024, impressed by the market potential of the nasal sprays segment, Biodeal’s position in contract manufacturing, and its adherence to global regulatory standards, Piramal Alternatives, Piramal Group’s Fund Management Division, invested Rs. 110 Cr. This investment is being used to enhance infrastructure, upgrade technology, and establish a dedicated nutraceuticals manufacturing facility, compliant with USFDA standards. The new facility, expected to be completed by 2026, will triple Biodeal’s production capacity and expand its market reach, positioning the company as a key player in the global CDMO landscape. With its focus on innovation, quality, and customer satisfaction, Biodeal is set to capitalize on the growing demand for finished pharmaceutical formulations globally.