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OUR EXPERTISE

What differentiates Lupin from the rest is that we have persevered to do the same things differently. Product Development to meet Global standards has been the key driver for Team Lupin. We focus on Good Regulatory Practices along with focusing on Good Manufacturing Practices, which helps us navigate through an ever-changing regulatory and IP landscape and adapt to the dynamic business needs.

We conform to ICH and biosimilar guidelines issued by US FDA, EMA, WHO, PMDA and the Indian regulatory bodies during the entire development and commercial cycle of our product. Our Manufacturing and the Regulatory teams work in tandem with our Clinical teams who have the expertise to carry out global multi-centric clinical trials.

The holistic effort of all our teams has positioned Lupin strongly in the rather crowded global biosimilars arena. In this highly competitive business, few winners will be determined by their long-term commitment to quality, cost effectiveness and steady meandering through rapidly evolving global regulatory and commercial landscape.

At Lupin, we pride ourselves in being at the vanguard of the relentless pursuit towards becoming a GLOBAL BIOSIMILAR PLAYER.

PIPELINE

Lupin Biotech facility is spread over 22,000 square meters at Pune, India. It houses a pipeline of 10 biosimilars in various stages of development.

In 2015, the first two Oncology products were commercialized in India – Lupifil and Lupifil-P (biosimilars for molecules Filgrastim and Peg-Filgrastim).

PIPELINE

Lupin Biotech facility is spread over 22,000 square meters at Pune, India. It houses a pipeline of 10 biosimilars in various stages of development.

In 2015, the first two Oncology products were commercialized in India – Lupifil and Lupifil-P (biosimilars for molecules Filgrastim and Peg-Filgrastim).

Biosimilar for Etanercept (brand Enbrel®) is being developed for Global markets. A Global Phase-III clinical trial is being conducted across Japan, India and Europe on over 500 patients and it is nearing completion.

Further, the developmental pipeline at Lupin includes a mix of blockbuster products of both microbial and mammalian origin across diverse indications such as Rheumatoid Arthritis, Oncology, Ophthalmology and Osteoporosis targeting a total global market of over USD 30bn.

GLOBAL BIOSIMILAR PIPELINE

CONTACT US

PUNE

LUPIN BIORESEARCH CENTRE

The Lupin Bioresearch Centre (LBC) located in Pune, India, has continuously maintained its outstanding performance on the regulatory compliance front with successful UK MHRA, US FDA, DCGI and NABL inspections in FY 2017 for conducting bioequivalence studies for Lupin’s generic products and branded formulations.

LBC has also managed Lupin’s outsourced bioequivalence studies including project management.

LBC has both clinical and bioanalytical capabilities - 2 in-house clinics and bioanalytical labs equipped with 14 high-end LC-MS/MS systems, 2 Ion Chromatography (IC) systems, 1 MSD / ELISA systems for PK/PD and Immunogenicity studies of Biosimilar products. LBC supports global clinical projects for Lupin’s R&D verticals in India, Japan and US.

In FY 2017, LBC established the in-vitro BE laboratory to conduct regulatory studies for Lupin’s respiratory product development program and established an efficient Biometrics department for its ANDA program. LBC completed 42 full studies during FY 2017 at its site, taking the cumulative tally to 267 studies and established about 200 validated analytical methods till date.