About

About LUPIN Biotech LUPIN Inc. (LUPIN Biotech's parent) is a $2.5B global Generic Pharma and BioSimilars company meeting the needs of patients around the World! Given our ongoing success, LUPIN Biotech now partners with biopharma developers as a preferred-choice provider of CDMO services to develop and produce their biotherapeutic assets (ADCs, mAbs, bsAbs, fusion proteins, etc.) through to IND and beyond (BLA/MAA and commercial launch). LUPIN's capabilities include CLD, analytical and formulation development, process optimization, scale-up, clinical and commercial DS/DP manufacturing, pre-clinical tox. studies, Phase I Safety Trials, as well as associated regulatory support. LUPIN provides biotherapeutic developers in-search of a qualified CDMO the following key advantages: I. Global, cGMP [mammalian] production capabilities at up to and including multiple 2000L scale using SUBs for a total of 15,000L capacity...already reviewed by major regulatory authorities around the world (EMA, PMDA, etc.) II. An expert team, experienced at successfully progressing our own biotherapeutics (e.g. our Enbrel biosimilar) through to approval in Europe, Japan, Canada and soon in the US III. An approved Quality System, routinely vetted by international regulatory agencies responsible for global product review and approval…Quality is ‘built-in’ by design, as part of the process IV. Reduced costs commensurate with an India-based labor force and associated low overhead affording ‘best-in-class pricing’ Most importantly, our location and affordable pricing enable us to offer clients considerable flexibility (e.g. customized payment terms), while delivering within budget and on-time.