Research & Development

Lotus operates a state-of-the-art formulation development center in India, supporting the development of high-potency oncology products as well as general pharmaceuticals. Our R&D organization brings together experienced specialists in formulation and analytical development, project management, intellectual property, clinical research, developmental quality, and packaging. The team is further supported by an in-house clinical research center accredited by major global regulatory authorities, including the USFDA and EMA.

For regulatory submissions and commercial production, product batches are manufactured at Lotus’ internationally accredited facilities, which are approved by regulatory authorities such as the USFDA, TFDA, PMDA and EMA, or at qualified partner sites. This approach ensures compliance with global standards and supports timely product launches worldwide.

A rigorous selection process ensures that we pick-up niche, difficult-to-develop products to augment our portfolio. Through an early identification, we focus on NCE-1s, paragraph IVs, difficult to develop, complex Generics or 505(b)(2)s.

Sourcing of the materials is an important aspect of the development and commercialization process. With a strong sourcing team, we pick-up the right quality of materials, complying to the applicable compendial requirements, at a best price to keep the cost-of-goods at reasonably low levels.

As a part of our continuous, cost-optimization process, the team regularly scouts for alternate/second source materials.

The current in-house product development focuses on difficult-to-develop, solid orals including but not limited to immediate release, extended release, multiparticulate, sublingual, granules etc for both high potent and general products.

The development portfolio also includes early-development opportunities to remain always ahead of the competitors.

Our skilled regulatory affairs specialists are fluent in the eCTD preparation and submission processes, and have completed several cases of ANDA applications.

Our Regulatory Affairs team is highly competent in the Global dossier preparation and submission processes. The team has a succesful track-record of filing and getting timely approvals for capitalizing on early launch opportunities for Global markets including the highly regulated markets as USA, EU, JAPAN,CANADA, TAIWAN, BRAZIL etc.