 "Shilpa Medicare surges 13% after receiving EIR from USFDA")
Shares of Shilpa Medicare have surged by 13% to Rs 434 per share on the BSE in morning trade after the company said that it has received Establishment Inspection Report (EIR) from the US health regulator for both of its facilities located at Raichur, Karnataka.
“Our both active pharmaceutical ingredient (API) manufacturing facilities located at Raichur, Karnataka, received EIR from the US Food and Drug Administration (US FDA),” Shilpa Medicare said in a regulatory filing.
This inspection was carried out between 16th and 19th January, 2018. The inspection has now been closed by USFDA, it added.
On January this year, Shilpa Medicare had announced that the USFDA has completed inspection of Company's API facilities Unit-I and Unit-II located at Raichur, Karnataka, India with three 483 observations. The Company said it is in the process of submission of corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines in response to the form 483 issued at the end of inspection.
In calendar year 2018, Shilpa Medicare had underperformed the market by falling 38% as compared to 6.4% rise in the S&P BSE Sensex till Tuesday. The stock hit 52-week low of Rs 374 on June 5, 2018 in intra-day trade.
At 10:05 am; the stock was trading 10% higher at Rs 424 against 0.09% gain in the benchmark index. The counter has seen multiple fold jump in trading volumes with a combined 492,116 shares changed hands on the BSE and NSE so far.
“Our both active pharmaceutical ingredient (API) manufacturing facilities located at Raichur, Karnataka, received EIR from the US Food and Drug Administration (US FDA),” Shilpa Medicare said in a regulatory filing.
This inspection was carried out between 16th and 19th January, 2018. The inspection has now been closed by USFDA, it added.
On January this year, Shilpa Medicare had announced that the USFDA has completed inspection of Company's API facilities Unit-I and Unit-II located at Raichur, Karnataka, India with three 483 observations. The Company said it is in the process of submission of corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines in response to the form 483 issued at the end of inspection.
In calendar year 2018, Shilpa Medicare had underperformed the market by falling 38% as compared to 6.4% rise in the S&P BSE Sensex till Tuesday. The stock hit 52-week low of Rs 374 on June 5, 2018 in intra-day trade.
At 10:05 am; the stock was trading 10% higher at Rs 424 against 0.09% gain in the benchmark index. The counter has seen multiple fold jump in trading volumes with a combined 492,116 shares changed hands on the BSE and NSE so far.
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