Shilpa Medicare gains 7% on EIR for Jadcherla formulations unit

The stock was 7% to Rs 488 on the BSE after the company received EIR from the USFDA for its formulation manufacturing facility in Telangana following the audit in November last year.

Shilpa Medicare has gained 7% to Rs 488 on the BSE in early morning trade after the company said that it has received Establishment Inspection Report (EIR) from the US drug regulator for its formulation manufacturing facility in Telangana following the audit in November last year.

“The US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for Shilpa Medicare Ltd's formulations manufacturing facility (SEZ unit) located at Jadcherla, Telangana, India which was inspected between 11th November and 30th November 2017,” Shipla Medicare on Saturday, March 16, 2018, said in a regulatory filing.

FDA has determined that the inspection classification of this facility is VAI (voluntary action indicated) and accordingly EIR issued. The earlier status of formulation unit is maintained, it added.

The stock hit a 52-week low of Rs 401 on the BSE on March 8, 2018 in intra-day trade. It had underperformed the market by falling 32% in past five months, against 2% rise in the S&P BSE Sensex.

In December 2017, the company had received 10 observations from USFDA in relation to SEZ formulation facilities situated at Jadcherla, Telangana. Out of the 10 observations, 7 were related to improvement in procedures and practices and 3 observations were related to setting of analytical specifications, test procedures and method validation.

At 09:43 am; the stock was trading 6% higher at Rs 484 as compared to a marginal 0.03% rise in the benchmark index. A combined 88,663 shares changed hands on the counter on the BSE and NSE.