Panacea Biotec share price was trading flat in the early trade on February 2 after USFDA classified the inspection conducted at company's subsidiary as 'Official Action Indicated' (OAI).
At 09:31 hrs Panacea Biotec was quoting at Rs 163.75, up Rs 0.25, or 0.15 percent, on the BSE.
Company’s material Wholly-owned subsidiary, Panacea Biotec Pharma Limited received a communication from the USFDA on January 31, 2024 indicating the inspection classification as “Official Action Indicated” (OAI).
United States Food and Drug Administration (USFDA) had conducted an inspection at Panacea Biotec Pharma Limited’s (PBPL) facility at Baddi, Himachal Pradesh, India from October 03, 2023, and October 12, 2023, and issued Form‐483 with 9 observations which are related to improvements in existing procedures and are addressable.
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements in which this facility is listed till the outstanding observations are resolved.
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PBPL continues to manufacture and distribute existing products for the US market, thereby not likely to have any material adverse impact on current business from the facility.
A meeting of the board of directors of the company is scheduled to be held on Tuesday, February 13, 2024, to consider and approve the standalone and consolidated unaudited financial results (Provisional) for the quarter and nine months ended December 31, 2023.
In December 2023, the company announced the launch of the world’s first fully-liquid wP-IPV based Pentavalent vaccine, EasyFourPol, in India and registration of Valganciclovir 50 mg/ml Powder for Oral Solution by its step down wholly-owned subsidiary," the company said in a press release.
Panacea Biotec is a biotechnology company involved in research and development, manufacturing, sales, distribution and marketing of pharmaceutical products and vaccines.
In the quarter ended September 2023 the company turned profitable as it recorded a net profit of Rs 3.20 crore.
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