Pharmaceutical company Ipca Laboratories was lower in early trade. The company recently acquired a stake in Unichem Laboratories and received a Form 483 from the United States Food and Drug Administration (USFDA) for three comments on its formulation manufacturing unit in Silvassa.
The USFDA inspected the Silvassa manufacturing facility from April 18, 2023, to April 26, 2023.
USFDA issues a Form 483 when a facility fails to comply with its manufacturing practices. Observations of non-compliance may result in issuing stricter Official Action Instruction (OAI) certificates or import bans, which may delay drug release.
Ipca Labs said in an exchange that it would provide a complete response to the USFDA’s observations within the specified timeframe and would work closely with the USFDA to resolve the issue as quickly as possible.
Indian pharmaceutical companies have been struggling to keep up with heightened regulatory scrutiny from USFDA recently as the COVID situation eased and the regulator resumed physical inspections.
Despite the challenges, USFDA approval plays a crucial role for Indian pharmaceutical companies, as sales from the US market account for a significant portion of these drugmakers’ revenues.
Ipca Labs was down 0.63 to Rs 696.95 at 10:32 am on the National Stock Exchange, falling for the third consecutive session. The stock fell about 17% in three sessions as Street was disappointed over the company’s expensive acquisition of Unichem Laboratories.