Gland Pharma facility in Vizag recieves EIR from U.S. FDA
Gland Pharma's facility in Visakhapatnam, which was earlier this year issued Form 483 with three observations by the U.S. Food and Drug Administration, has since received an establishment inspection report from the agency, the generic injectable focussed company said on Tuesday, a development that saw its shares close 1.43% higher at ₹1,768.75 apiece on the BSE.
The receipt of the EIR indicates closure of the U.S. FDA inspection conducted in February, the company said in a filling.
A pre-approval inspection (PAI) for sterile active pharmaceutical ingredients (APIs), the U.S. FDA had inspected the facillity from February 19-25 and on conclusion issued a Form 483 with three observations. The company had then said the observations are procedural in nature and it will submit the corrective and preventive actions to the agency within the stipulated period. The observations issued are neither repeated observations nor related to data integrity, Gland Pharma had said.
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