Shares of Shilpa Medicare gained nearly 4% on Friday after the company announced that the United States Food and Drug Administration concluded its inspection at the company’s Bio Analytical Laboratory in Hyderabad with zero observations.
The US drug regulator conducted an inspection at Bio Analytical Laboratory, Unit 7, in the Nacharam area of Hyderabad, from February 26 to March 1, Shilpa Medicare said in a filing to the stock exchanges on Friday.
The inspection has now been concluded and closed by the US health regulator without any 483 observations, the company said.
This implies that Shilpa Medicare’s said laboratory in Hyderabad showed satisfactory compliance towards the facility, systems, and acceptability of the data generated from the said laboratory.
This newly set-up Centre for bio-analytical testing received European Regulatory Authority clearance recently.
“This Unit of Shilpa Medicare is engaged in testing of biological samples that supports all exploratory pharmacokinetic studies, bioavailability studies and bioequivalence studies, while complying with good clinical practices and good laboratory practices as per the global regulatory standard,” the pharmaceutical company said in an exchange filing on March 1, 2024.
The pharma company’s shares gained as much as 3.72% to a high of ₹432 apiece on BSE. The stock gained over 12% in the last one month and nearly 20% over the last three months. So far in the year, Shilpa Medicare’s shares have jumped 30%, while increasing significantly by 62% in the past one year.
Shilpa Medicare Ltd shares closed at ₹418.35 apiece, up 0.3%, on BSE.
(Edited by : Ajay Vaishnav)
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