Cadila up 4% on EIR report from USFDA for Ahmedabad SEZ unit

Cadila Healthcare shares surged more than 4 percent intraday Friday after oral solid dosage drug facility in Gujarat received establishment inspection report from the US health regulator. "Oral solid dosage drug manufacturing plant located at SEZ, Ahmedabad has received an establishment inspection report (EIR) from the USFDA," the pharma company said in its filing. The US health regulator had carried out inspection of this facility in January 2016. Cadila said the receipt of EIR

indicated the successful closure of the inspection points (483s) raised. This plant is a separate manufacturing unit and does not form a part of the Moraiya formulations manufacturing facility. With this, the company received EIR for three facilities so far during the current quarter, including Moraiya plant that had received a warning letter in December 2015. At the same time, Ahmedabad API facility (Zyfine) also had a warning letter from the USFDA. However, in July, Moraiya facility received an establishment inspection report from the USFDA, which only indicated closure of the inspection points (483s) raised based on the inspection carried out between August 28, 2014 and September 05, 2014. "It does not in itself indicate resolution of the warning letter, though this is a positive step towards the resolution of the warning letter issued by the USFDA," Cadila had said in its filing on July 8. Its Topical manufacturing facility located at Changodar, Ahmedabad also received EIR, in August, following the inspection in March 2016. This plant is a dedicated facility for manufacturing ointments and does not form a part of the Moraiya formulations manufacturing plant.

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