Alembic Pharma’s Gujarat facility gets establishment inspection report from US FDA

Drug firm Alembic Pharmaceuticals, on Monday, said it has received establishment inspection report (EIR) from the US health regulator for its new injectable facility at Karakhadi in Gujarat.

The company has received EIR from US Food and Drug Administration (USFDA) for the inspection carried out by them at their new injectable facility at Karakhadi during the period from January 28, 2021 to February 6, 2021, indicating that the USFDA finds their responses to its observations to be adequate, Alembic Pharmaceuticals said in a regulatory filing.

They were issued 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 regard to this particular inspection.

The US regulator has also indicated that a compliance verification would be performed during re-inspection of the said facility in the next review cycle. Alembic has around 10 injectable filings from this particular plant.

Alembic has been a stock, which has been particularly under pressure post its Q1 numbers, because that was the time they withdrew their Rs 50 EPS guidance due to an underperformance in the US markets, which had declined around 38 percent on a year-on-year basis in Q1 and hence this would be a possible positive for its US markets.

The stock is trading at around 16 to 17 times FY23 PE as compared to its valuations, which were at a peak of around 23 times when compared to its 52-week high.

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