Biophore: A Trusted Organization in the Global Generic Industry

The Silicon Review

“Our mission is to be a trusted R & D company in the complex and niche pharmaceutical molecule segments and achieve superior Customer Satisfaction.”

Founder’s Word- “Our aim is to place Biophore amidst most reliable knowledge based firms in the API sector in the immediate near future through customer-focused approach,” asserts Dr. Jagadeesh Babu Rangisetty.

Over the years, the Generic Pharmaceutical industry has grown leaps and bounds and one such company that stands testimony to it, is Biophore. Set up in the year 2007, the company today has emerged as a trusted partner in generic industry across the US, Europe and other regulated markets. Considered as one amongst the few companies in the global generic market who understand the product complexities to the core, Biophore offers an end to end technical support to its clients. Biophore understands the trends of the market better and this gives the competitive edge over the counterparts.

The satisfied customers consider Biophore as a one-stop solution for all their API needs, which is why they desire to remain associated with them forever. A specialist in handling APIs for Injectable Formulations, most of the Biophore’s customers include Formulation Companies. A big pharma customer, leader in the field of Contrast Media who visited their Manufacturing facilities has lauded their efforts in the field of Contrast Media and chose Biophore as their partner. Biophore which focused only on regulated markets like US and EU, is now focusing on the middle-east, CIS, ASEAN and ROW markets.

Well, that’s not all, Biophore endeavors a rewarding work environment to its employees, achieve superior customer satisfaction through innovative development and achieving operational excellence in delivering complex and niche pharmaceutical products to Generic Market.

Story behind its Inception

Napoleon Bonaparte had once said “The truest wisdom is a resolute determination.” With the same belief, patience and persistence Dr. Jagadeesh and Dr. Manik moved back to India from the US in 2007. Both the technocrats setup a small-scale chemistry lab and formed a team with seven chemists in Hyderabad to work on API products involving complex chemistry in non-infringing routes of synthesis.

For the next 3 years, the company grew slowly yet consistently, working mostly on niche and complex molecules while gaining a reputation for innovation, quality and reliability. In 2010, the company filed its first US DMF and since then, the company began to expand its research to a more number of projects. At any point of time, R & D is involved in development of 80 + APIs and about 10 FDFs.

Evolved as a trusted player over the years for Active Pharmaceutical Ingredient market across US and EU markets, Biophore owns the base of about 400 companies globally out of which about 200 companies are from the US, with few Big Pharma players in the customer base. Biophore’s unique portfolio of products is spread across 30 therapeutic categories which include Oncology products; Synthetic Peptides, High Potent APIs, Colored products, Contrast and Diagnostic Media. Biophore’s revenues are growing consistently at a rate of 60-70%.

Meet the Dynamic Duo

Dr. Jagadeesh Babu Rangisetty, Founder and Chief Executive Officer - Responsible for giving direction and overseeing the company’s growth as a global generic R & D enterprise, Dr. Jagadeesh carries 25+ years of hands-on research experience. He also brings key insights into day-to-day operations ensuring effective delivery mechanisms are in place, compliant with global standards.

Known as an expert in the field of Medicinal Chemistry and Drug Discovery, Dr. Jagadeesh owns more than 50 patents and 70 publications to credit. He holds a Ph.D. from BITS Pilani and obtained his postdoctoral and research experience at VCU, VA.

Dr. Manik Reddy Pullagurla, Founder and Chief Scientific Officer - Carrying 16+ years of rich research experience in the academia and the Industry, Dr. Manik foresight and attention to details have helped Biophore achieve success. A very well respected individual amongst the Pharmaceutical fraternity, he owns more than 45 patents and publications over 17 years of research. He holds a B. Pharm (Hons.) from BITS Pilani and Ph.D. from VCU, VA. He gained his post-doctoral experience from UGA, GA.

Products Offered

Biophore’s portfolio is a unique mix of product lines that include macromolecular complexes, synthetic peptides, oncology products and contrast & diagnostic media. With a focus on requirements of regulated markets like US & EU, Biophore has invested into a state-of-the-art R&D center to develop novel polymorphs, processes, co-crystals and new drug delivery systems.

Research at Biophore compliments science with innovative approach and creates a “technology based approach” to develop novel and non-infringing products. The company respects the innovative approach and ensures every such innovation is reinforced with intellectual property. Biophore’s 50 patents in the areas of non-infringing processes & polymorphs and 60+ DMFs with various drug regulatory authorities highlight the devotion towards the pharmaceutical sciences.

“The demand for quality and compliance is constantly building up and the recent collaborations of US FDA with EU authorities calls for a rigorous method to ensure the compliance. Current scenario stresses on being ready to adapt to new technology and not just new products.” - Says the Team.

Adapting the concept of Quality by Design (QbD) at every level of Research, development and manufacturing, Biophore uses solid phase synthesis, ultrafiltration, lyophilization, dialyzers and many such advanced techniques. Product quality and performance is achieved and assured by design of effective and efficient manufacturing processes.

Biophore has always adapted the latest analytical techniques likes of HPLC Derivatization, coronary aerosol detectors, customized and novel procedures to determine SSA, advanced capillary electrophoresis techniques for synthetic peptide analysis. The research facility hosts the advanced instrumentation for hyphenated techniques like LC-MS; IC-PMS, LC-NMR, CE-MS, LC-FTIR and more.

In a move to bolster the capabilities and contribute to an affordable medicine, Biophore acquired a solid oral formulations manufacturing facility “Zenara Pharmaceuticals”. This acquisition offers more flexibility to Biophore’s customers by decreasing the costs involved in finding and adapting a suitable partner for formulation development. Zenara is an EU GMP compliant and is accredited with certifications from WHO GMP; EU GMP; ZAZIBONA, DCA and DHMA.

The Future Sight

In its 10th anniversary year (2017), Biophore continues to focus in the areas of Contrast Media, Oncology and difficult to characterize APIs. Also, the company strives to contribute to better medicine by adapting and applying the latest technology involved in Pharmaceuticals by giving an inclusive atmosphere to its employees and constant up-gradation in operational excellence. In the coming years, Biophore is focused on filing its own FDF and make the Zenara Pharmaceuticals compliant to US FDA.

On the market front, the company which was earlier focusing only on regulated markets like US and EU, is now focusing on the middle east, CIS, ASEAN and ROW markets.