Lupin Biotech was setup in 2008 with a vision to make high quality biologics more affordable and accessible to the patients globally. Lupin’s Biotechnology Development Program is based out of Pune in India. The state-of-the-art Research facility was founded in 2008 with advanced capabilities like development, manufacturing and pre-clinical studies to clinical programs in biotech products required for approval in both regulated as well as semi-regulated markets. The cGMP facilities for microbial as well as mammalian cultures was commissioned in 2010.
The Biotech Group has a talent pool of close to 300 people comprising of approximately 11% Ph.Ds and 63% post graduates.
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. Along with focusing on Good Manufacturing Practices, Lupin also focuses on Good Regulatory 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 the US FDA, EMA, WHO, PMDA and the Indian regulatory bodies during the entire development and commercial cycle of our product. Our Manufacturing and Regulatory team works 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, the few winners will be determined by their long term commitment to quality, cost effectiveness and steady meandering through the rapidly evolving global regulatory and commercial landscape.
We at Lupin pride ourselves in being at the vanguard of the relentless pursuit towards becoming a global biosimilar player.
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, 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 trials being conducted across Japan, India and Europe on over 500 patients 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.
Lupin Limited (Biotech Division),
Gat No 1156, Village Ghotawade, Taluka Mulshi | Pune | 412115
Lupin Limited (Biotech Division), 1st and 4th Floor, G.O Square,
Sr. No. 249 / 50, Near Mankar Chowk, Wakad, Pune- 411057, India
Mr. Gopal Rao
SR. MANAGER – Global BD and Services Outsourcing
Tel |+91-20-66549975 | Email email@example.com
89 Headquarters Plaza, North / Suite 1428 / Morristown, NJ 07960
Dr. Anshuman Patwardhan
VP - Global Licensing & Business Development (Biotechnology)
Direct: 443-740-9343/ Email: firstname.lastname@example.org
Mr. Anjan Selz
VP-Head of Biosimilars, EMEA
Direct: +41 (0)78 611 92 55/ Email: email@example.com
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The manufacturing facility has been designed to meet the global quality and regulatory requirements with separate suites for microbial and mammalian products with stringent control.
The Microbial facility spans 9000 sq feet and is equipped with a dedicated purification suite catering to large scale fermenters.
The Mammalian facility spans 9000 sq feet and is equipped with large scale cell culture bioreactors in disposable and stainless steel formats.
The downstream purification suite can produce several kg of protein using automated chromatography systems.
The Fill/Finish multiproduct set up to cater to global commercial supplies of Biosimilars is now operational and is capable of handling Vials and PFS in–house. Spread over 1000 sq feet at the Lupin Limited Biotech division in Pune this fill finish plant is compliant to US FDA and EMEA requirements.
The manufacturing activity is supplemented by a strong quality team. State of the art quality control laboratories have been set up. The quality Assurance team is capable of ensuring the requisite documentation as per the cGMP norms, including product release as per the global regulatory requirement.
Our R&D infrastructure encompasses the complete product development spectrum from clone development to process optimization, orthogonal analytical methods to developing finished products. We employ Quality by Design through Design of Experiments throughout the development cycle. Our formulation arm can develop both novel and generic formulations either in the aqueous or lyophilized forms coupled with the diverse fill finish presentations – vials, prefilled syringes and autoinjectors.
Our centralized clinical team handles clinical trials for Lupin’s Biosimilar Pipeline and Lupin NCE’s for Global submissions. They have exhaustive experience in managing all phases of clinical trials for various indications. Clear insight of Clinical and Regulatory requirements for bio therapeutics for global approvability is one of their key strengths. In addition the team has extensive global trial management capabilities along with working and managing global CROs to conduct multi-country patient trials in indications like Oncology, Inflammation and Ophthalmology.