R&D



At Strides Shasun, latest technology and high technical expertise in research, culture of innovation and unique ability to identify market opportunities has resulted in a robust pipeline of products to meet the growing global requirements of Pharma markets as they face the challenges of an off-patent regime. The focus of the team at R & D is on hi-end value products which are niche in terms of development complexity, formulation design and characterized by high entry barriers.

Over 500 strong integrated R&D team offers solutions across the entire product development value chain including strategic sourcing, API development, identification and characterization of the reference drug, Patents review, formulation development, analytical method development and validation of both APIs and the finished dosages, Technology transfer, Stability, Bioequivalence, Toxicological studies, Packaging development and Regulatory Submissions.

R&D is actively engaged in the development of a wide variety of dosage forms. Special emphasis is on novel delivery systems for solid orals (Modified Release tablets and Capsules) and soft gelatin capsules for both Regulated and Emerging markets.

Our API development skills, innovative formulation development skill sets, combined with competitive development costs and the ability to provide end-to-end customer support, have established the Division as a value-added growth engine. The API R & D center is equipped with state of the art analytical equipment and is approved by FDA as testing laboratory.

The integrated development approach ensures distinct advantages to organization. Primarily, it helps to have own Control over key input material’s quality attributes, Cost control across life cycle of product & de risking the supply chain surprises.

Our strong formulation R&D capabilities together with our knowledge of the regulatory environment in Regulated markets have resulted in successful dossier registrations in several markets. As on 2017, Strides Shasun have filed 38 API US DMFs. Also, submitted 66 ANDAs to US FDA & received full approval for 34 ANDAs & tentatively approval for 3 ANDAs. In addition to these, Strides Shasun have 17 tentative approval for PEPFAR ANDAs. Strides Shasun has approximately 1000 dossiers submitted across other Global Markets. Strides Shasun hold over 200 approved registrations and marketing authorizations in Regulated markets like Australia, Canada and European countries.

Our current ANDA pipeline includes Para - IV filings and early launch opportunities in US Market.

R&D VALUE CHAIN
  • Technical Expertise

    Strong technical leadership to develop high-quality pharma products that create strategic value for our partners and customers



  • Product Selection

    Focus on niche products characterized by complex formulations across diverse therapeutic categories

  • Development

    R&D capability to develop over an entire cycle (Active Pharmaceutical Ingredient to Finished Dosage Forms) with new and better technologies at competitive cost

  • Regulatory Review/Filing

    Strong IP assessment capabilities and global regulatory expertise