Drug is chosen primarily for their active ingredients. Active Pharmaceutical Ingredients aka, Active Pharmaceutical Ingredients or bulk drugs are portions of any drug, which are active and impart its therapeutic value. Thus, depending on the drug’s administered dosage, the reactions and results differ. Certain drugs are comprised of more than one kind of API.
Any drug is composed of two components or aspects. The first is the actual API or Active Pharmaceutical Ingredients, which is the central ingredient. The second is known as an excipient. This refers to the substance inside the drug or formulation.
Regardless of where the active pharmaceutical ingredient is made, companies must adhere to strict safety and quality standards set by the country where it will be used.
As a result of lesser molecules getting approved in the market and generic-drugs emergence, Big Pharma companies are increasing their focus on generic versions of the drugs. Meanwhile, emerging generic players are competing with the big pharma players and are raising their R & D investments and increased focus on the generic-drug market. This heavy competition is forcing the players to have the early access to API.
Launching generic API is a challenging proposition requiring rigorous scientific research, enormous risks of costly failures and validation trials. With hard work and rigorous R&D, these challenges have never inhibited Biophore in becoming a leading APIs supplier. Biophore develops the APIs for new Generic Drug using processes which do not infringe the branded drug’ patents and has become the most trusted R&D driven company focusing on creating superior value and proposition by providing ‘end to end’ APIs solutions and achieving excellent satisfaction through continuous innovation.
Biophore has two USFDA approved world class manufacturing facilities along with two state-of-the-art R&D set-ups and a business office in New Jersey, the USA for operations support. R&D center at Hyderabad is the main center and has an area of 60,000 sq.ft. Visakhapatnam’s Facility is a small set up to support the central R&D. The company owns 40 DMFs and 50 patents in the field of process and polymorphs which show the dedication towards the research and development.
Meet “Magnum Opus” of Chemistry
Dr. Jagadeesh Babu Rangisetty, Founder and Chief Executive Officer (CEO) of Biophore, serves on its Board of Directors. In this role, Dr. Jagadeesh is responsible for providing direction and overseeing the company’s growth as a global generic API’s R & D enterprise. With 22+ years of hands-on research experience, Dr. Jagadeesh brings key insights into day-to-day operations ensuring effective delivery mechanisms are in place, compliant with global standards. Previously, Dr. Jagadeesh has served as the Vice-President and founding partner of Navita LLC, USA.
Dr. Jagadeesh is viewed as an expert in the field of Medicinal Chemistry and Drug Discovery, and has over 70 patents, has authored numerous articles in leading medical publications. He holds a Ph.D. from BITS Pilani and obtained his postdoctoral and research experience at VCU, VA.
“Our aim is to place Biophore in the midst of most reliable knowledge based firms in the API sector in the immediate near future through customer-focused approach,” asserts Dr. Jagadeesh Babu Rangisetty.
Dr. Manik Reddy Pullagurla, Founder and Chief Scientific Officer (CSO) of Biophore, also serves on the Board of Directors. Dr. Pullagurla has 16+ years of rich research experience in the academia and the Industry. His foresight and attention to details have facilitated Biophore achieve success. With over 45 publications and patents Dr. Pullagurla is well respected amongst the Medical and Pharmaceutical fraternity. He holds a B. Pharm (Hons.) from BITS Pilani and Ph.D. from VCU, VA. He gained his post-doctoral experience from UGA, GA.
“We are prioritizing our research and development efforts in the areas of complex chemistry and characterization, and categorize our APIs based on the therapeutic indications they cover and by their dosage forms,” assures Dr. Manik Reddy Pullagurla.
Biophore Foundation: No Secret of Success, Only Hard Work
Biophore was founded by Dr. Jagadeesh Babu Rangisetty and Dr. Manik Reddy Pullagurla in 2007. Dr. Jagadeesh hails from village Chiluvuru of Andhra Pradesh. He always had a dream of starting his own business or a pharmaceutical company. But being from a middle-family, lack of capital from father’s Govt. job and lack of previous experience limited the dream of starting a pharmaceutical company. To pursue the dream, Dr. Jagadeesh felt the importance of higher education, and this paved the way into the research. Dr. Jagadeesh joined BITS Pilani where he pursued his Masters in the field of Medicinal Chemistry, and the passion towards the research motivated him to focus on drug discovery. BITS Pilani, which he adores a lot transformed his personality and sown the seeds of entrepreneurship.
As a passionate chemist and as an aspiring entrepreneur, Dr. Jagadeesh felt that real contribution to the field could be made only through research that is useful to discover new drug. He then approached industry experts and entered into “first of its kind” collaboration at BITS Pilani and successfully developed several leads for drug candidates to treat brain related disorders and to treat malaria.
His research at BITS lasted for six years for which he was awarded a Ph.D. in Medicinal Chemistry. His intense desire for research and fascination towards brain disorders made him attracted towards works of Dr. Professor Richard A. Glennon, who was one of the pioneers in the field. Impressed by Jagadeesh’s research and achievements, Prof Richard offered a position in his department at Virginia Commonwealth University to continue his research in the area of Drug Abuse, Drug Dependence, Migraine, Alzheimer’s for six years and published in several prestigious journals. It is during the same period when he met Dr. Richard Glennon’s another student Dr. Manik Reddy, Post Graduate in Chemistry and Ph.D. in Medicinal Chemistry. Meeting Dr. Manik was a fortunate stroke of serendipity for Dr. Jagadeesh. The duo shared interests and passion towards chemistry, and their association grew closer and stronger. These strong ionic bonds of friendship latter laid the foundation for Biophore.
In 2002, Dr. Jagadeesh with his few other friends started a company Navinta in the USA, which developed technologies for complex generics. Though Dr. Jagadeesh was quite satisfied with the venture, he was also enduring his dream of starting a company in India. His dream was on the verge of realization when Dr. Manik liked the idea. With the undying ambition to start a pharmaceutical company in India and with strong belief, both Jagadeesh and Manik moved back to India to start a technology development center with the same model. Research in India, then and even to an extent now is more through the traditional approach with a lack of proper infrastructure which made the duo work harder to keep their ambition alive.
The transition from being a successful start-up to a take-off was a tough task, but the struggle never hindered the ultimate goal. Biophore has filed 40 DMFs as a whole since its inception but the last three years have been exceptionally good in which the company filed 25 DMFs. They believe that this could contribute well to the Generic Pharmaceutical industry.
Biophore’s R&D portfolio encompasses projects of different natures covering New Chemical Entities (NCE), Generic APIs, Niche APIs, grandfather products and few excipients diversified across different therapeutic areas and at the various stages of development. Niche APIs covers the following therapeutic areas of Oncology, Multiple Sclerosis, Topical Medications, Contrast/ MRI Media, Diagnostic, Iron/ Ferric Products. Biophore is quite successful in this area, and they plan to invest more in this area to maximize specific opportunities that involve patent challenges and complex chemistry.
“We aim to position ourselves as the most trusted API source across all therapeutic segments,” says Dr. Jagadeesh.
Biophore: Family of Superlative Experts
Dr. Jagadeesh feels that the employees are the extended family and reason for company’s growth. He believes that the performance of the company lies with employees and is proud of the low attrition in the company and loyalty towards the organization. Dr. Jagadeesh always remembers the cooperation of employees and the contribution they made when the organization was going through a rough phase. He also reminisces the days when employees offered the company to pay lesser salaries and how they dedicated themselves to fulfill commitments and develop the organization. To give back, Biophore introduced a unique performance based appraisal system which facilitates the employees to benefit beyond their salaries. Dr. Jagadeesh, whose education was funded by relatives, feels that family and economic status should not be an obstacle to education. His vision motivated Biophore to start a program which sponsors several schools and students who are willing to pursue higher education. Jagadeesh wishes to extend this to many more schools as the company grows bigger.
Aiming High & Dreaming Big
The company always strives to keep updated with the latest trends in the field of pharmaceuticals and to deliver the products with unrivaled quality and compliance. Biophore is working in three primary areas where to see growth opportunities as described as below;
Firstly, further broadening of the product range. Secondly, on exploring the markets like Latin America, Middle East, and ROW, which till now were untouched by them. They currently supply APIs to about 100 companies across US, EU, India and few other markets. Thirdly, penetration into the US market which contributes to a significant chunk of their revenues & the European and Indian Market. To support the plan, Biophore has invested into its new and manufacturing facility which is set to be operational in 2018. In the US, they are focused on strengthening their working relationship and product engagement with current customers and simultaneously penetrating the market irrespective of the size of the customer business.
Having maintained relevance as an API manufacturer for about nine years, Biophore is aiming to evolve into one of the most trusted sources in the API segment. Their research that once began as the small lab in Hyderabad has grown into a 60,000 sqft state-of-the-art facility. Full-Fledged facility with the strength of about 250 scientists, exemplifying their focus and dedication towards the pharmaceutical research.
“We are one of the largest suppliers for a couple of Contrast Media APIs in the Europe. Being successful with the diatrizoic acid derivatives and now are planning to develop and commercialize gadolinium-based products and iodine-based contrast media,” divulge Dr. Manik Reddy.
Biophore’s major challenge for the products selection is the patents and polymorphs. Dr. Jagadeesh firmly believes innovation as a component of the success for any organization those banks on technology. Innovation at Biophore starts with identification and selection of differentiated products. The challenge to maintain the uniqueness of portfolio involves two most important aspects. The first aspect is to select a product with complexities which made it less competitive and the other aspect is to see that the chosen product is a low volume and also involves multistep synthesis. And that’s how the areas of Biophore’s research are APIs for Oncology, Peptides, contrast media and diagnostic agents.
As the thought for the future, Biophore is poised to be a full-fledged Research & Development company with 300 scientists and supporting staff this year by September and aspires to be positioned to be in top 10 suppliers of APIs to Regulated Markets in near future.
Biophore: Transforming Chemicals into Medicines
