Acquiring Perrigo’s facility in Maharashtra, India, means Stride has a third API plant with US FDA approval.
Strides Arcolab changed its name to Strides Shasun last November after amalgamating with Shasun Pharmaceuticals in 2014.
Just before Strides and Shasun united, the former firm obtained two US FDA approved active pharmaceutical ingredient (API) plants in India and Italy.
CEO of the Strides group, Shashank Sinha, said: “With this acquisition, we bring into our fold a manufacturing facility designed to handle multipurpose small bath productions and accelerate our time to market,” in a statement.
The Perrigo plant has a manufacturing capacity of over 600 tons per year for a range of APIs for complex generics on the WHO listed essential medicines – including chemotherapies, anti-fungal and allergy medications.
For Perrigo API’s plant in Maharashtra, there is unlikely to be any need for a regulatory re-evaluation to maintain its US FDA approval status after the acquisition.
This was confirmed by Kristofer Baumgartner, a spokesperson for the US FDA, who told in-Pharmatechnologist “A facility’s compliance history typically stays with it, regardless of change in ownership.”
In August, Strides Shasun decided to ‘hive off’ its API business into a subsidiary, to tackle a new set of statutory and regulatory compliance demands.
Shasun’s other two US FDA approved plants include an oral dosage manufacturing facility in Bangalore, and a semi solids facility – Beltapharm – in Milan, Italy.
The Bangalore plant majors in gelatin capsule production, with an annual capacity of 2.5 billion soft gel capsules.
Arun Kumar, executive vice chairman and managing director of Stride told Deal Street Asia “The commodity API business continues to put pressure on margins with cost of compliance going up.”
The deal to buy Perrigo API India will close December 31.