Indian drugmaker Lupin has completed the acquisition of US-based Gavis Pharmaceuticals and Novel Laboratories (Gavis) in a previously announced deal worth $880m.
The move comes on the heels of Lupin and Gavis’ announcement to sell the rights and assets for two generic drugs, in order to address regulatory concerns over their merger.
The plan for the acquisition was announced in July last year, when both the companies inked an agreement.
The acquired business will expand Lupin’s presence in the US generic market, in addition to expanding its portfolio in dermatology, controlled substance products and other niche generics.
It also includes Gavis manufacturing facility, which will support Lupin’s inhalation R&D centre in Coral Springs of Florida.
Lupin CEO Vinita Gupta said: "We are very pleased to have completed our acquisition of Gavis. The Gavis portfolio augments our US business and niche generic pipeline.
"We plan to leverage the formulation expertise of Gavis to enhance both Lupin’s generic as well as speciality pipeline."
Based in New Jersey, Gavis is involved in formulation development, manufacturing, packaging, sales, marketing, and distribution of pharmaceuticals products.
The firm currently has 62 ANDA filings pending approval with the US FDA, as well as pipeline of more than 65 products under development.
Nearly 72% of Gavis’ filings pending approvals represent niche dosage forms with 18 Para IVs and eight First-to-File (FTF) products.
According to Lupin, Gavis’ pending filings are expected to have a market value of approximately $9bn.
Lupin has 37 FTF products, which includes 17 exclusive FTF opportunities. Lupin and Gavis combined would now have more than 45 FTFs.
The combined company will have a portfolio of more than 120 in-market products, more than 185 cumulative filings pending approval and a pipeline of products under development for the US.
The deal creates the fifth largest pipeline of ANDA filings with the US FDA.