Pittsburgh-based Mylan has signed a definitive agreement to acquire Agila Specialties Private Limited, a developer, manufacturer and marketer of high-quality generic injectable products, from Strides Arcolab for $1.6 billion in cash.

The acquisition of Agila will significantly expand and strengthen Mylan's global injectables platform and provide Mylan entry into new high-growth geographic markets. The acquisition is expected to be immediately accretive to Mylan's adjusted diluted earnings per share following closing, and is expected to close in the fourth quarter of 2013.

"The addition of Agila to our existing injectables platform will immediately create a new, powerful global leader in this fast-growing, attractive market segment and accelerate our target of becoming a top-three global player in injectables,” said Mylan CEO Heather Bresch. “Importantly, Agila will bring us one of the most state-of-the-art, high-quality injectables manufacturing platforms in the industry."

Mylan president Rajiv Malik added, "Agila will bring Mylan one of the deepest and broadest global injectables portfolios in the industry, and together we will have more than 700 marketed injectables products and a global pipeline of more than 350 injectables products pending approval. In addition, Agila will provide us entry into key growth markets such as Brazil."

Agila, headquartered in Bangalore, India, will bring Mylan a product portfolio of more than 300 filings approved globally and marketed through a network covering 70 countries, including 61 abbreviated new drug applications (ANDAs) approved by the FDA. Agila has a global pipeline of approximately 350 filings pending approval, including 122 ANDAs pending FDA approval.

Agila currently produces products across nine manufacturing facilities in India, Brazil and Poland, eight of which have been approved by the FDA. Its capabilities complement Mylan's existing injectables platform of more than 500 products marketed globally, including 55 ANDAs, and its sterile manufacturing facilities in Ireland and India.