India approves Mylan’s purchase of Agila

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India approves Mylan’s purchase of Agila

Home/Pharma News | Posted 11/10/2013 0 Post your comment

Generics giant Mylan announced on 3 September 2013 that its proposed acquisition of generics injectables maker Agila Specialties (Agila) from Strides Arcolab for Rs 5,168-crore (US$1.6 billion) had been cleared by the Indian Government.

Mylan announced the deal back in February 2013 [1], but has been waiting for Indian Government’s approval before proceeding. The US-based company has now finally received approval from India’s Foreign Investment Promotion Board (FIPB), as well as from the Cabinet Committee on Economic Affairs (CCEA).

The decision comes at a time when concerns have been raised about multinational firms acquiring Indian companies. In fact, the Parliamentary Standing Committee on Commerce has even gone so far as to suggest the introduction of a ‘blanket ban’ on foreign investments in existing pharmaceutical projects [2].

Perhaps in response to these concerns, the acquisition is subject to certain conditions, for example, Mylan has to maintain investment in R & D in value terms for five years. Furthermore, the company also has to maintain the production level of National List of Essential Medicines (NLEM) drugs and consumables and their supply to the domestic market.

Mylan’s CEO, Ms Heather Bresch expects the acquisition to ‘establish Mylan as a global injectables leader, with a significantly expanded and strengthened injectables portfolio, pipeline, platform and capabilities’. India-based Agila will bring a broad 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 FDA.

Mylan expects the acquisition of Agila to be finalized in the fourth quarter of 2013.

Injectable generics at Strides Arcolab

References

1. GaBI Online - Generics and Biosimilars Initiative. Mylan to acquire Strides Arcolab’s injectable generics business [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 11]. Available from: www.gabionline.net/Generics/News/Mylan-to-acquire-Strides-Arcolab-s-injectable-generics-business

2. GaBI Online - Generics and Biosimilars Initiative. India to make prescribing of generics compulsory [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Oct 11]. Available from: www.gabionline.net/Policies-Legislation/India-to-make-prescribing-of-generics-compulsory

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Source: Mylan