The combination will create India’s largest pharmaceutical company and the world’s fifth largest generics maker, with combined sales estimated at US$4.2 billion. The combined entity will have 47 manufacturing facilities across five continents, along with a strong portfolio of specialty and generic drug products marketed globally, including 629 abbreviated new drug applications (ANDAs).

The deal comes at a time when Ranbaxy, which is majority-owned by Japan’s Daiichi Sankyo, is under increased scrutiny by the US Food and Drug Administration (FDA). In January 2014, FDA banned Ranbaxy from exporting drugs to the US from its Toansa plant, which manufactures around 70–75% of Ranbaxy’s active pharmaceutical ingredients, after an inspection highlighted violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The company’s other India-based factories at Paonta Sahib, Dewas and Mohali are already banned from exporting drugs to the US [1]. Exports from the Dewas and Toansa plants to Europe have also been suspended, due to non-compliance with Good Manufacturing Practice (GMP). But this is not the end of Ranbaxy’s troubles. The company has also been subject to recalls, with its Jacksonville plant in the US recalling 64,626 bottles of atorvastatin tablets in March 2014 after a pharmacist discovered a 20 mg tablet in a bottle that was supposed to contain 10 mg doses [2].

Not surprisingly, Sun Pharma is reported to be planning to gradually re-brand Ranbaxy drugs sold in the US as Sun Pharma treatments, although the brand is likely to continue to be present in other markets.

The agreement still needs shareholder and regulatory approvals, but Sun Pharma expects the takeover to be completed by the end of 2014.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues Ranbaxy with Form 483 for violations at Toansa plant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 18]. Available from: www.gabionline.net/Generics/News/FDA-issues-Ranbaxy-with-Form-483-for-violations-at-Toansa-plant
2. GaBI Online - Generics and Biosimilars Initiative. Indian generics makers face US recalls [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 18]. Available from: www.gabionline.net/Generics/News/Indian-generics-makers-face-US-recalls

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