Can you provide an overview of Biophore’s specialization and the company’s offering to the US market?

Biophore has been filing drug master files (DMF) since 2010, and as of 2021, we have filed over 100. We are now one of the leaders in DMF filings to the USFDA. Biophore has a very diversified portfolio, but our current focus is more on specialized fields such as peptides and oncology. Another area of strength for Biophore is contrast agents. We are very active in Europe, and now bringing these products to the US market also. We are investing heavily in these areas.

What makes the peptides and contrast media fields so appealing?

There are very few peptide manufacturers in India, but most of the generic industry today is dependent on India for their APIs. Peptides need specialized technology in terms of their characterization and manufacturing. Biophore believes that peptides are a good area to invest in, both in terms of the IP and manufacturing. The same goes for contrast agents.  

Where are Biophore’s manufacturing facilities located and what is the current focus at these facilities?

Biophore has four API manufacturing facilities, all located in Pharma City in Visakhapatnam. We manufacture approximately 130 products from these four facilities, which operate at cGMP standards and meet the requirements of US and EU Drug regulatory authorities. Each facility has a specialization -one focusing on large volume products; one on steroids, peptides, APIs, and macromolecular complexes; another on oncology; and one on contrast agents.     

What has been the impact of Covid-19 on your business?

Biophore has been extremely fortunate as we have had a significantly good year in terms of growth during this pandemic. We have also not seen any negative impact in terms of business in the US market. We have been involved in manufacturing a Covid-19 drug called Favipiravir, and we are one of the leading manufacturers of this particular API. All starting materials and complex intermediates are either sourced locally or have been developed in-house for use. We manufacture a lot of our own starting materials and have control over our supply chain, making us non-dependent on China.    

How does Biophore ensure the highest quality control practices are implemented in its facilities?

For Biophore, quality is paramount. We are focused on regulated markets with global specifications, and have therefore invested significantly in ensuring best quality practices in our facilities which meet international standards. We have different layers to our quality management systems and also have a corporate quality department which functions like an external agency monitoring our facilities.

Do you see India’s growth making the domestic market a more viable end market for Biophore in the future?

We have been thinking of entering the domestic market for a long time, but this has not happened yet because of our focus on specifications for regulated markets. You cannot have two specifications for different markets, and you need to focus on one specification to maintain good quality standards. Having two specifications, one for the regulated market and one for the domestic market, compromises quality. For APIs that we want to introduce into the domestic market, we will build a separate facility which we hope will happen in 2021.

What is the importance of Hyderabad for the US market and can you speak to the role generics play in bringing affordable drugs to US consumers?

I believe that Hyderabad is the capital of the pharma industry, especially on the API front. There is significant competition in the city which cultivates growth and quality. For the last couple of years, affordability, pricing, and quality of drugs have been highly discussed topics. India plays a very significant role in terms of controlling prices and delivering affordable drugs to the US market, due to competition and the quality that can be delivered.

What is your vision for the company for the next 2-3 years?

Currently, Biophore is filing approximately 15-20 DMF per year. We want to accelerate this number and file at least 25 DMFs per year. This means that we will need some additional capacities and we are thus investing in a greenfield facility project where we will manufacture different kinds of APIs. We believe that this facility will be operational within the next year. We also want to increase our focus on key starting materials manufacturing on very selective high-volume APIs as to lessen our dependence on China.