Strides Technology and Research's (STAR) high technical expertise, culture of innovation and unique ability to identify market opportunities has resulted in a robust pipeline of products to meet the growing requirements of Pharma majors as they face the challenges of an off patent regime. The focus of the team at STAR is on hi-end value products that are niche in terms of development complexity and formulation design and characterised by high entry barriers.
The 350 strong R&D team offers solutions across the entire product development value chain including strategic sourcing, identification and characterisation of the reference drug, patent and regulatory review, formulation development, analytical method development and validation, stability and bioequivalence studies, packaging development, regulatory filings and technology transfer.
STAR is actively engaged in the development of a wide variety of dosage forms like parenterals (liquid injections in vials/ampoules/prefilled syringes, dry powders and lyophilised products) including novel delivery systems like liposomes and peptides, solid orals (coated and uncoated tablets) and soft gelatin capsules for both regulated and emerging markets. Our domains of focus are oncolytics, peptides, penems, ophthalamics and biosimilars. In the biosimilar segment, through our acquisition of biotechnology company, Inbiopro, we have access to a team of 20 scientists who are engaged in developing biosimilar recombinant therapeutic proteins, vaccines and have strong capabilities in high expression mammalian and microbial platform-based development.
Our strong R&D capabilities together with our knowledge of the regulatory environment in regulated markets have resulted in successful registrations in several markets. As of December 31, 2010, we have 140 ANDA filings (104 in steriles) with 51 approvals (32 in steriles) in addition to 112 product registrations in established markets and 930 in emerging markets and the rest of the world.
Our innovative formulation development skill sets, combined with competitive developments costs and the ability to provide end-to-end customer support, have established the Division as a value added growth engine.
As the R&D Division continues in its quest to create differentiated delivery formats and provide end-to-end customer support, its value and significance to Strides will only be enhanced.