Aurobindo Pharma is a generics and active pharmaceutical ingredient (API) manufacturer based in India. The company has recently had three of its generics approved by the US Food and Drug Administration (FDA) [1].

The company had also signed a deal with the generics unit of Novartis, Sandoz, to acquire its US generic oral solids and dermatology businesses, including three manufacturing units.

The deal was agreed in September 2018 for a total of US$1 billion, which would have been the largest overseas acquisition to be made by an Indian drug manufacturer. An upfront payment of US$900 million was offered by Aurobindo, followed by performance-based pay outs of the remaining US$100 million.

However, it was announced in April 2020 that the deal had fallen through due to a delay in approval from the US Federal Trade Commission.

A statement from Aurobindo said: ‘This decision was taken as approval from the US Federal Trade Commission for the transaction was not obtained within anticipated timelines’.

At a recent board meeting, held on 3 June 2020, it was announced that Aurobindo had approved the transfer of its biosimilars business (including related R & D and manufacturing sites) to its subsidiary, CuraTeQ Biologics, a Swiss company based in Lucerne. The transfer will increase the company’s focus on biological products.

The company faces major competition from Biocon, a large biosimilars manufacturer headquartered in Bangalore, India. Biocon have recently had three of their manufacturing sites approved by FDA [2].

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Non-innovator biologicals in India: regulatory context and areas for improvement

Aurobindo and Lannett expand their generics portfolios

References
1. GaBI Online - Generics and Biosimilars Initiative. Aurobindo Pharma receives FDA approval for three generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 19]. Available from: www.gabionline.net/Generics/News/Aurobindo-Pharma-receives-FDA-approval-for-three-generics
2. GaBI Online - Generics and Biosimilars Initiative. US FDA clears Biocon manufacturing sites in Malaysia and India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 19]. Available from: www.gabionline.net/Biosimilars/General/US-FDA-clears-Biocon-manufacturing-sites-in-Malaysia-and-India

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