Alembic Pharma facility in Gujarat gets facility inspection report from us from FDA
Pharmaceutical company Alembic Pharmaceuticals said on Monday it had received the establishment inspection report (EIR) from the US health regulator for its new injection facility in Karakhadi in Gujarat.
The company received an EIR from the United States Food and Drug Administration (USFDA) for the inspection it performed at its new injection facility in Karakhadi during the period January 28, 2021 to February 6, 2021 , indicating that the USFDA finds their responses to its comments adequate, Alembic Pharmaceuticals said in a regulatory filing.
They received five observations during the inspection. Basically the issuance of an EIR, which has been pending for so long, so the street was wondering what had happened with this particular inspection.
The US regulator also indicated that a compliance check would be carried out during the re-inspection of the said installation during the next review cycle. Alembic has about 10 injectable deposits of this particular plant.
Alembic was a stock that came under particularly pressure after its first quarter figures, as that was when it pulled its forecast of Rs 50 EPS due to underperforming US markets, which were down about 38% year-on-year. on an annual basis in the first quarter and, therefore, that would be a positive potential for its US markets.
The stock is trading at around 16 to 17 times the PE FY23 over its valuations, which peaked around 23 times from its 52 week high.
-With PTI inputs
(Edited by : Dipikka Gosh)