Biophore flourishes as one of the most trusted firm in API segment for global generic industry

Biophore flourishes as one of the most trusted firm in API segment for global generic industry

Pharmaceutical industry has evolved from offering broad-spectrum therapies to targeted delivery and is now heading towards precision medicine. Contemporary pharmaceutical companies have outgrown the traditional drug delivery systems like the tablets, capsules & injections. There are more precise and novel delivery systems which include but are not limited to liquid crystals, liposomal delivery systems and Nano-technology.

The advancements in pharmaceuticals are often disruptive and are a challenging proposition to make sure that every dollar spent meets the needs of the market. The technology is iron-clad with intellectual property that resists the genericization of the innovations. Generic industry in-turn is on par with innovators and is so far successful in offering affordable medicine. It is obviously a challenging proposition to develop the technology that is non-infringing and yet be profitable.

Biophore, a unified pharmaceutical company is counted among the global leaders in the space for successful development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs) for generic industry. Since its establishment in 2007, Biophore has been devoted to deliver innovative niche and complex pharmaceutical products that have outpaced customers’ expectations. A strong culture of research and innovation pervades the work environment at Biophore and this has enabled the firm to emerge as the most trusted R&D driven company that is aimed at creating remarkable value by providing end to end APIs solutions. The company has achieved a range of accomplishments which envelop 50 patents in the areas of non-infringing processes & polymorphs and 70 DMFs (Drug Master Files) with various drug regulatory authorities; also, formulation of eighty products which are in various stages of development.

The firm was founded by Dr. Jagadeesh Babu Rangisetty and Dr. Manik Reddy Pullagurla with the profound vision of making a real contribution towards invention of new drugs with continuous research and innovation. Dr. Jagadeesh Babu, a Postdoctoral Researcher in Medicinal Chemistry at Virginia Commonwealth University, USA followed his passionate desire for research in brain disorders. He was offered a position in the department so that he can pursue his research in related domains. During his tenure, he befriended Dr. Manik Reddy, another research scholar in the same department. The enterprising spirit in Dr. Jagdeesh had always encouraged him to establish a pharmaceutical company in India. He wanted to devote all his learning to work towards the welfare of his motherland. Dr. Manik liked his idea and both of them decided to move back to India and start a research center to work on API products involving complex chemistry in non-in-fringing routes of synthesis. Maintaining a research facility and carrying out research has always been a challenge in developing nation like India. However, the duo’s most sincere efforts towards the realization of their mission didn’t let such challenges hinder their progress.

Today, Biophore has two USFDA approved state-of-the-art manufacturing facilities placed in Vishakhapatnam that are compliant with cGMP standards and norms of US and EU Drug regulatory authorities. These facilities host dedicated laboratories for each category of products like peptides, hormones, colored APIs, oncology and high potent drugs.The operations of these two manufacturing facilities are supported and mentored by two world class Research& Development set ups located in Hyderabad and Vishakhapatnam and a business office in New Jersey, USA. Spread on 80,000 square feet workspace, the research facility in Hyderabad is the main center and houses latest equipments upgraded with the technological advancements in the field of pharmaceutics while the facility at Vishakhapatnam is put in place to support the operations of the main center.

Research and Innovation – Biophore’s Backbone

Biophore’s technology development centers have gained a competitive advantage in developing and commercializing processes for APIs and fixed dose formulationsfor the regulated markets. These centers boast robust capabilities in conducting projects across diversified disciplines including New Chemical Entities (NCE), Generic APIs and Niche APIs which cover Oncology, Multiple Sclerosis, Topical Medications, Contrast /MRI Media, Diagnostic, Iron/Ferric Products. Apart from that, they also deal with grandfather products and few excipients diversified across different therapeutic areas and at the various stages of development. The firm is now doing all the groundworktowards investing more in this area.Speaking about Biophore’s prime focus on research and innovation, Dr. JagadeeshBabu Rangisetty, Founder & Chief Executive Officer at Biophore shares, “Research at Biophore compliments science with innovative approach and creates a ‘technology based approach’ to develop novel and non-infringing products. Biophore respects the innovative approach and ensure every innovation is reinforced with intellectual property.”

Exclusive Product Portfolio

Biophore’s extensive capabilities in understanding product complexities coupled with a powerful framework for providing overall technical support to clients have empowered the firm to lead as one of the top API suppliers in the global landscape. An unswerving focus towards research and innovation enables the company to stand tall among the rest while capacitating itnot only to analyze and identify market trends better but also to find out inventive ways for expanding its reach to its customers. Biophore’s broad product portfolio goes in line with the company’s mission –‘To be the most trusted R & D company in the complex and niche pharmaceutical molecule segments and achieve superior Customer Satisfaction through  Continuous Innovation’. In a chat with The CEO Magazine, Dr. Jagadeesh says, “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. From API to Filing, Biophore provides a comprehensive support for Analytical, Quality and Regu­latory Procedures. Biophore is a core R&D organization which strives to provide cost-effective, non-infring­ing and complex APIs.”

Plush Clientele

Having kept a proactive approach towards realization of its mission, Biophore has been able to make a name for itself in US, EU and other regulated markets forActive Pharmaceuticals. The company’s rich client portfolio envelops more than 160 companies on a global scale including some Pharma giants. Many of them listed in IMS top 20 global corporations and Forbes 2015 top 50 Pharmaceutical Companies secure spots in the company’s client base. Biophore acts as an integrated solutions provider to meet their varied and complex API requirements. The firm now rules the industry space as a trusted chemistry partner to large organizations for MRI Contrast Media. Moving ahead on its success journey, Biophore is now all set to enter the Semi-Regulated, ASEAN and CIS Markets. Dr. Manik Reddy Pullagurla, Co-founder & Chief Scientific Officer at Biophore shares, “Biophore has always been customers’ best of choices for NCE molecules for P IV opportunities and also for niche APIs with launch on approval opportunities.”

Innovational Strides for Unparagoned Competence

  • Development of novel, non-infringing polymorphs for molecules like Regadenoson, Palbociclib; and of novel processes for molecules like Tavaborole
  • Development of novel routes of synthesis for molecules like D – Penicillamine
  • Robust method to detect inorganic impurities in inorganic active pharmaceuticals that often go undetected.
  • Developed several sustainable and precise analytical techniques that are applauded across the industry
  • Export oriented multipurpose units for handling products that span over 30 therapeutic categories

‘Zenara’ for affordability

Biophore’s acquisition of a solid oral formulations manufacturing facility ‘Zenara Pharmaceuticals’ has facilitated the firm to benefit its customers by helping them identify and get on board with Contract Manufacturing Organization (CMO) at the right time at affordable costs. Zenara holds compliance with EU GMP and its processes are certified from WHO GMP, EU GMP, ZAZIBONA, DCA and DHMA. Focusing on Contract manufacturing and Contract development services, Zenara has obtained a strong foothold in the market with production of gums and lozenges for Nicotine replacement therapy. With enhanced capabilities after acquisition, Biophore is all set to develop Novel Drug Delivery Systems for generic medicines. 

Road Ahead

For a decade, Biophore directed its efforts towards delivery of niche products and APIs. Within a few years of its inception, the company has enlisted itself among top 10 API companies in terms of the number of US DMFs filed. As it steps into tenth anniversary in 2017, the firm is all set to follow a clear roadmap towards making strides in new territories which include Biosimilars, Biobetterand Next Generation antibody macromolecules; while it continually strives to achieve excellence in the field of small molecule generics. In addition to that, the company is exploring opportunities of growth along three verticals. It has been working on further expansion of product portfolio and has robust plans for extending its footprints in markets like Latin America, Middle East and ROW. Towards broadening its penetration into US, EU and Indian Markets, the firm has established its third manufacturing facility, which will start its operations in 2018. The firm is poised to achieve a successful growth rate in future and flourish as the one among the most trusted and knowledge based firms in API sector. Biophore has initiated several collaborations with various educational institutions to encourage the innovations from the academics. This encourages the aspirant chemists and budding scientists towards the research and development.

Meet the Maestros

Dr. Jagadeesh Babu Rangisetty, Founder & Chief Executive Officer at Biophore is an expert in Medicinal Chemistry and Drug Discovery. More than two decades of hands on research experience in highly coveted research facilities around the globe coupled with his passion for entrepreneurship encouraged him to establish Biophore IndiaPharmaceuticals & Biophore PharmaInc. Being a part of Biophore’s Board of Directors, Dr. Jagdeesh oversees Research and Development functions of the organization and its growth as a global generic API supplier. With his profound experience, he monitors effectiveness of delivery mechanisms and guides on implementation of best practices. Prior to founding Biophore, he served NAVINTA LLC, an organization that developed technologies for complex generics, as Vice Presidentand Founding partnerfor 5 years. He received Masters Degree in Medicinal Chemistry from Birla Instituteof Technology & Science, Pilani and served there as a Faculty for 6 years. He earned his Doctorate in Medicinal Chemistry from BITS, Pilani and conducted postdoctoral research for six years at Virginia Commonwealth University, USAin the area of drug discovery for NeuroTherapeutic agents. Besides Biophore,he hasalso found LeiutisPharmaceuticals., India & LeiutisPharmaceuticals Inc., USA; Sionc Pharmaceuticals;Azico-Biophore & EnixtaInnovations Pvt. Ltd.He has more thanpatents to his name in the field of pharmaceutical Chemistry.

Dr. Manik Reddy Pullagurla, Co-Founder and Chief Scientific Officer at Biophorecomes with a two decades of rich experience in academics as well as Corporate. He earned his Doctorate in Medicinal Chemistry from Virginia Commonwealth University, USAand has more than 45 patents to his credit in the field of pharmaceutical chemistry. He also serves Biophore as a Member of Board of Directors. He holds a B. Pharm (Hons) from Birla Institute of Technology & Science, Pilani.

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