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Good News for Ranbaxy - Plants of Gurgaon and Romania gets FDA nod

 

Clinical courses

Ranbaxy saw some good news from the US drug regulator just days before the announcement of its acquisition by Sun Pharmaceutical in a $4-billion deal inclusive of debt.

Units of Ranbaxy's R&D centre at Gurgaon and its clinical research centre related to bioequivalence and bioavailabilty at Terapia Ranbaxy, its subsidiary in Romania, were inspected by the USFDA in March. Romania site is conducting studies for oral contraceptives meant for the US market, when inspected by FDA in late March.

This comes after the Gurgaon-headquartered drugmaker was hit by several strictures last year and faced two import alerts by the FDA, which blocked it from shipping products from plants at Toansa and Mohali since September to the world's biggest drug market.

Interestingly, in March, Ranbaxy's Paonta Sahib plant in Himachal Pradesh, which has faced a US regulatory bar since 2008, was also cleared in a joint inspection by five global drug regulatory agencies of the UK, Canada, the WHO and Singapore in December.

Source: Economic Times