“We want to emerge as the most trusted API firm in complex drug molecule segments”

#SpeakPharma with Biophore

2023-09-30

Impressions: 3312

This week, Speakpharma interviews Dr. Jagadeesh Babu Rangisetty, CEO of Biophore India Pharmaceuticals. The Hyderabad (India)-based company has four US Food and Drug Administration (FDA) and European Union inspected manufacturing facilities for active pharmaceutical ingredients (APIs) situated in Visakhapatnam, one dedicated intermediate facility and a world-class R&D lab housing 500 scientists with varied expertise. Now, the company hopes to emerge as the most trusted organization in the complex and niche pharmaceutical molecule segments.

Can you provide an overview of Biophore’s expertise in developing complex APIs?

Since our inception in 2007, Biophore has established itself as a company that focuses extensively on R&D to deliver exceptional value and end-to-end solutions to our clients.

In 2010, we filed our first DMF (drug master file) in the US. Since then, we have successfully filed over 120 DMFs in the US and over 25 Certificates of Suitability (issued by the European Directorate for the Quality of Medicines), along with regulatory filings across Canada, China, Korea, Middle East and North Africa (MENA) and other global markets. Over the past five years, we have consistently ranked among the top 5 DMF filers.

Our primary focus is to leverage our research strength and deliver products with complex chemistry and high entry barriers to our clients. Over the years, we have developed such an expertise in niche and complex products and our customers look to us when it comes to critical products.

We operate four world-class facilities that allow us to cover a wide range of therapeutic areas. Currently, Biophore serves over 300 customers, including several top 20 pharmaceutical companies.

Can you explain the role of Biophore’s state-of-the-art technology development center in development of these products?

Our state-of-the-art technology development center, situated in Hyderabad (India), plays a central role in advancing the development of niche pharmaceutical products. It serves as a research and innovation hub, allowing us to generate new ideas, work on them and deliver a robust product fit for the global markets.

The center is equipped with specialized laboratories for various therapeutic segments, such as peptides and oncology products and also has sophisticated analytical instruments that facilitates complex API characterizations. Our dedicated research team is working on over 20 development projects at any given time.

What are some of the key therapeutic areas that Biophore focuses on?

Biophore focuses on several niche and complex therapeutic areas such as oncology, peptides, contrast media, colored APIs, hormonals, iron products, and injectable APIs. We have deep expertise in delivering time bound APIs to the market. We are also recognized as a global leader when it comes to products for orphan indications to provide treatment options for rare diseases.

What are some of the challenges being faced by Biophore, and how does the company address them?

The generic industry has been facing challenges of late due to various factors. These include intense price pressures, supply chain disruptions and increasing competition.

To tackle these obstacles, we have implemented a range of strategies. One, we have adopted a backward integration approach for intermediates that gives us greater control over the supply chain and reduces our reliance on external sources. Two, rather than focusing on a single market for all our products, we target multiple global markets. This approach mitigates risks associated with market fluctuations and regulatory changes.

Additionally, we place significant emphasis on delivering new and distinctive products. By offering a unique product portfolio, we set ourselves apart from our competitors, establish a competitive advantage and attract a broader customer base.

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Can you provide an overview of Biophore’s expertise in developing complex APIs?

Can you explain the role of Biophore’s state-of-the-art technology development center in development of these products?

What are some of the key therapeutic areas that Biophore focuses on?

What are some of the challenges being faced by Biophore, and how does the company address them?