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Based out of Pune, Lupin Biotech, our world-class R&D centre was founded in 2008 with advanced capabilities in areas like development, manufacturing and pre-clinical studies to clinical programs in biotechnology products required for approval in both regulated and semi-regulated markets.
The developmental pipeline includes a mix of blockbuster products of both microbial and mammalian origin, across diverse indications such as rheumatoid arthritis, ophthalmology, oncology and osteoporosis indications.
Highlights for FY 2017
The coming year has exciting milestones to look forward to, especially with MAA filings slated in Japan and Europe. The manufacturing facility is also gearing up for audits by respective regulatory agencies and paving a path for swift commercialization of the product.
Comprehensive regulatory strategies are being devised to optimize the development timelines. Clinical trial initiation for two more priority projects are planned in the upcoming year, in addition to the ongoing trials for Etanercept.
The pipeline is well positioned to ride the wave of upcoming biosimilars in the short and long term respectively. High throughput methods, automation and future technologies are being put to test for the development and selection of high-yielding Biosimilar clones.
The Company’s efforts during the year resulted in its filing 3 National Phase patents in the global markets accompanied by 2 provisional patents and 1 PCT application.
Lupin Biotech plans to progress across markets with international partners possessing complementary capabilities in product development, IP generation and commercialization. This would help to mitigate risk and achieve higher execution success. The Company hopes to realize our ambition of positioning Lupin Biotech as a global player navigating complex regulatory, IP and socio-economic framework.