 "Alembic Pharma, Cadila Healthcare gain on getting EIR from USFDA")
Shares of Alembic Pharmaceuticals and Cadila Healthcare have rallied by up to 8% on the BSE in intra-day trade after these companies announced that they have received Establishment Inspection Report (EIR) from that US Food and Drug Administration (USFDA) for their manufacturing facilities.
Alembic Pharmaceuticals has rallied almost 8% to Rs 624 on the BSE, after the company said it has received EIR from USFDA for the inspection carried out by them at its Karakhadi API plant III in April 2015.
Cadila Healthcare surged 6% to Rs 364 on the BSE after the company said its Moraiya manufacturing facility has received an EIR from the USFDA.
“This receipt of EIR only indicates closure of the inspection points (483s) raised based on the inspection carried out between August 28, 2014 and September 05, 2014. What is "closed" is the initial review that resulted in the warning letter issuance,” Cadila Healthcare said in a regulatory filing.
Though this is a positive step towards the resolution of the warning letter issued by the USFDA, it does not in itself indicate resolution of the warning letter. The company is in constant follow up with the USFDA for resolution of the warning letter, it added.
At 01:38 PM, Alembic Pharmaceuticals and Cadila Healthcare were up 4% each at Rs 603 and Rs 358, respectively, as compared to 0.18% fall in the S&P BSE Sensex.
Alembic Pharmaceuticals has rallied almost 8% to Rs 624 on the BSE, after the company said it has received EIR from USFDA for the inspection carried out by them at its Karakhadi API plant III in April 2015.
Cadila Healthcare surged 6% to Rs 364 on the BSE after the company said its Moraiya manufacturing facility has received an EIR from the USFDA.
“This receipt of EIR only indicates closure of the inspection points (483s) raised based on the inspection carried out between August 28, 2014 and September 05, 2014. What is "closed" is the initial review that resulted in the warning letter issuance,” Cadila Healthcare said in a regulatory filing.
Though this is a positive step towards the resolution of the warning letter issued by the USFDA, it does not in itself indicate resolution of the warning letter. The company is in constant follow up with the USFDA for resolution of the warning letter, it added.
At 01:38 PM, Alembic Pharmaceuticals and Cadila Healthcare were up 4% each at Rs 603 and Rs 358, respectively, as compared to 0.18% fall in the S&P BSE Sensex.