Pharma Major Lupin Limited (Lupin) announced that it has completed its acquisition of privately held US based GAVIS Pharmaceuticals LLC and Novel Laboratories Inc. (GAVIS). Lupin had announced the acquisition on July 23rd 2015. The acquisition enhances Lupin’s scale in the US generic market and also broadens Lupin’s pipeline in dermatology, controlled substance products and other high-value and niche generics. GAVIS brings to Lupin a highly skilled US based Manufacturing & Research organization which would complement Lupin’s Coral Springs, Florida based R&D center for Inhalation. GAVIS’s New Jersey based manufacturing facility also becomes Lupin’s first manufacturing site in the US.
New Jersey based GAVIS is a privately held company specializing in formulation development, manufacturing, packaging, sales, marketing, and distribution of pharmaceuticals products. GAVIS has 62 ANDA filings pending approval with the US FDA and a pipeline of over 65+ products under development. 72% of these filings pending approvals represent niche dosage forms with 18 Para IVs and 8 FTFs products. GAVIS’s pending approvals address a market of over USD 9 billion.
The combined company will have a portfolio of over 120 in-market products, over 185 cumulative filings pending approval and a deep pipeline of products under development for the US. The acquisition creates the 5th largest pipeline of ANDA filings with the US FDA, addressing a USD 63.8 billion market.
Lupin has 37 First-to-File (FTF) products which includes 17 exclusive FTF opportunities. Lupin and Gavis combined would now have over 45 FTFs.
