Jagadeesh Rangisetty

Founder & CEO

The demand for active pharmaceutical ingredients (API) across the world is rising rapidly, resulting from the advancement of the pharmaceuticals sectors and innovation of new drugs, particularly for critical ailments. As the demand continues to rise, global pharma manufacturers are turning to India to meet their API needs. India has emerged as a reliable partner due to the abundance of scientific skill along with the ability of API manufacturers to provide cost-effective, high-quality products with quick turnaround times. Additionally, API manufacturers boast matured manufacturing capabilities with comprehensive infrastructure, further enhancing their production capacity.

However, several companies concentrate on high demand products, minimizing the availability of limited use APIs. As such, the demands of the global healthcare sector often remain unfulfilled. Additionally, lack of innovation poses the challenge of competition in the industry. Addressing these challenges by catering to niche and complex products and focusing on innovation is the Hyderabad-based Biophore India Pharmaceuticals. A prominent player in the industry, Biophore offers a comprehensive range of innovatively created products to meet the requirements of markets that require APIs with high entry barriers.

Developing Complex APIs

Biophore’s primary strength lies in research and development initiatives, which is further facilitated by the firm’s practice of focusing on niche and complex products. With its strategy of catering to specialized streams, the company has bagged key clients in oncology, rare diseases and contrast media. Dedicated to continuous innovation, the company invests heavily in research, development, and manufacturing capabilities which has allowed it to grow its portfolio to over 200 products and publish a number of patents for its innovations.

Biophore harnesses the expertise of its research experts, who have been carefully handpicked to research various industrial advancements and develop and deliver products that meet the requirements of the company’s diverse clientele.

“At Biophore, we strongly believe that the greatest asset of the organization is the people capital. And this capital needs to be complemented by providing empowerment and freedom to innovate at every level in the company. There is a conscious effort by the organization to provide this freedom to employees to make decisions and provide the relevant resources to implement them. This has created a sense of ownership within the employees and the results are seen in the way each and every employee operates and helped us create a dedicated space for ourselves in a crowded market”, shares Dr Jagadeesh Babu Rangisetty, CEO of Biophore.

Emerging from Biophore’s extensive research initiatives is its ability to locally develop and manufacture APIs for a global clientele, catering effectively to their unique demand for products for various therapies, including rare diseases. By efficiently developing these products, Biophore supports their initiatives to reach the market early, thereby ensuring end users (the patients) get quicker access to potentially life saving products. In addition to developing APIs, the company also often supports its clients’ development endeavors by leveraging its own technology.

Some of the key innovations rolled out by the firm that were first-to-market and first-generic products include rare disease therapies, Cannabidiol, anti-COVID products, Ethiodized oil, contrast media, and others.

Manufacturing Excellence

With four manufacturing facilities for its API offerings, situated in Pharma City, Visakhapatnam, Biophore has strengthened its ability to manufacture its comprehensive | 1 7 |OCTOBER 2024 range of products in line with the global regulatory norms. All four of the manufacturing facilities that Biophore operates are developed to align with the US FDA and EU approved standards, apart from cGMP regulations. Moreover, every one of the facilities handles a particular specialization whether it be large volume products, steroids, peptides, macromolecular complexes, oncology or contrast agents.

One of the company’s USPs is that it can manufacture varied quantities of products, whether the client wants a few grams or tonnage levels. In providing such flexibility, the company has also established a track record of manufacturing diverse products without compromising on compliance adherence. Moreover, the seamless transition from R&D to manufacturing is a distinctive quality, one that Biophore is widely known in the industry for.

“Biophore’s development and manufacturing is done keeping in mind the highest standards of regulations and compliance. There is also a growing trend in the pharmaceutical industry in terms of integration to maintain control and costs. We manufacture our products from KSM stage, which is where our dedicated intermediate facility for maintaining capacities comes into the picture. It helps in debottlenecking our capacities and helping us maintain control over our value chain”, further shares Dr Rangisetty.

Experts in incorporating the global requirements for APIs into a single product and delivering the same quality across the diverse markets where it is present, Biophore stands out for its ability and dedication to develop products for the global consumer.

Catering to the domestic markets as well as the ROW markets, the company stands up to its promise of delivering the right products at the right time, in adherence to compliance, regulations and at competitive rates. This capability has been honed and facilitated by the company’s strong partnerships and collaborations with top generic players across the globe for the past many years and multiple branded innovator companies who look at Biophore as a viable alternative to their own development and production.

“Biophore strongly believes that long term collaboration and partnerships are key to be a successful API organization globally. In this competitive world, it is very easy to find alternatives and unique products are almost non-existent. Hence, it is important to foster relationships where you are viewed as more than just a supplier”, further shares Dr Rangisetty.

Quality Assurance

Manufacturing specialty products, Biophore places paramount importance on quality of products, ensuring that the regulated markets with global specifications that it caters to get their needs met effectively. As such, the firm has placed comprehensive, multi-layered quality practices in its facilities that meet international standards. An additional corporate quality department, acting as an external agency to monitor quality further enhances the firm’s quality practices.

Having implemented an umbrella system for quality assurance, the company saves time and resources by not having to make modifications to specific products, thereby optimizing the overall process. Every activity conducted at the facility is bound by the distinctive Biophore quality framework, and every facility itself, has cleared inspections conducted by global authorities like the US FDA, EMEA, ANVISA, COFEPRIS, and WHO GMP among others.

Future Roadmap

Established in 2007, Biophore has positioned itself as a reliable partner in the industry through hard work and strategic expansions over the years. As it courses towards the future, the firm is driven by its vision to place Biophore in the midst of most reliable knowledge based firms in the API sector in the immediate near-future through a customer-focused approach.

Whereas the firm is currently filing between 15 to 20 DMFs a year, it aims to increment this in the coming years to achieve at least 25 DMFs a year. At the same time, the company is also planning to invest more in innovation and research and grow further in the domestic and ROW markets while making a market-specific portfolio of products and building capacities through organic or green field facilities.