Rubicon Research started its operations in early 2000 as a contract research organization providing generic formulation development services to Indian and European companies. It soon graduated to working on new drug delivery platforms like extended release systems, orally disintegrating tablets and drug coating technologies. By 2003 Rubicon Research had added many feathers to its cap like approval as a commercial R&D company from the government of India’s directorate of science and technology (DST), filing of its first international patent. Around this time, Rubicon started developing drug delivery technologies to meet the specific needs of its global pharmaceutical customers and in 2005, it licensed out its first controlled release product to a US-based company.
With its portfolio of proprietary technologies, Rubicon started providing solutions to the common pharmaceutical problems like low bioavailability, taste masking challenges and custom release profiles and got global recognition as a drug delivery company when it licensed its ODT (Orally Disintegrating Tablet - RubiODT) excipient to Mallinckrodt Baker (MBI). This ODT excipient is marketed worldwide by MBI as PanExcea ODT.
Expanding its horizon further, in 2008, Rubicon commissioned its cGMP facility at Ambernath, thus vertically integrating its business model and becoming a one stop shop in the area of formulation development. Rubicon’s cGMP facility allows submission of CMC data for any NDA/ sNDA/ ANDA applications, thus eliminating the need of technology transfer to other companies thereby protecting the intellectual property. Addtionally it is also a first of its kind facility in India, offering the entire gamut of clinical supply services, from clinical manufacturing to Clinical Trial Material (CTM) depot. Clinical trial supplies can be organized for multicentric trials in a structured way from this facility.
With a built up area of 6500 sq. mt, Rubicon’s plant is well equipped for manufacture of registration batches for regulatory submissions of CMC part and also undertakes manufacturing of commercial supplies.
The Unique Selling Proposition (USP) of this facility is its flexibility to manufacture batches from development quantities (< 5kg batch size) to commercial batch sizes (250 kg batch size).
The facility is designed to conform to USFDA, EMEA compliance and has already received approval from German Health Authority “Freie und Hansestadt Hamburg” for stability and analytical services compliant to European norms. The certification is valid for 27 European countries. The facility is also successfully audited by some of the major global pharmaceutical companies for manufacturing and clinical trial supply services.
Today Rubicon, the “one-stop” business portfolio, offers a unique set of integrated services to meet the comprehensive needs of pharmaceutical firms with extended services like Stability Studies Management and Regulatory Affairs services.
Taking one step at a time, in the last decade, Rubicon has strengthened its position as an ideal partner for strategic sourcing in product development for the worldwide market.