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OVERVIEW

Active pharmaceutical ingredients (APIs) are entrenched in the foundations of Lupin and are a backbone to the organization.

Historically, along with being one of the most vertically integrated pharmaceutical companies Lupin has also consciously focused on building scale and efficiencies-making it an undisputed leader in its chosen product segments.

Lupin has remained a global leader in therapeutic segments such as Cephalosporins, Cardiovascular and the Anti-TB space for over 15 years.

For the FY 2015 revenue from our API business was Rs.11,941 million as compared to Rs.9,498 million in FY 2013, growing at a CAGR of 12 % despite price pressures.

The Company has re-focused its API group into making further inroads into markets such as US, Europe, Japan and exploring new opportunities in emerging markets like China, Brazil, Mexico, Korea and Russia.

As part of its new growth plan Lupin’s API business targets on developing 4-6 new APIs per quarter with renewed focus & investment on API R&D.

KEY HIGHLIGHTS - Highlights, FY 2014

  • Filed 19 ANDAs and 11 DMFs in the US; received approvals for 22 ANDAs as well as one supplemental NDA (New Drug Application) from the US FDA during FY 2014
  • Filed 2 exclusive first-to-files for the generic versions of Prolensa® and Quartette®
  • Received project milestones payments of USD 8.8 million for 2 products that are currently under joint development with Medicis Pharmaceutical Corporation, US
  • Completed Phase-I studies in Europe for a program in the CNS area, which is being advanced to Phase II clinical trial now
  • Candidates from two programs in the area of endocrine disorders and cancer, entered clinical phase during FY 2014
  • The Company acquired Nanomi B.V. in Netherlands for its patented technology platforms that would help develop products in the Complex Injectables space
  • Set up a joint venture with Japanese pharmaceuticals company Yoshindo to address the biotech opportunity in Japan