Alembic Pharma Gets Two U.S. FDA Observations For Karkhadi Plant
None of the observations are related to data integrity and are addressable, the company said.
The U.S. drug regulator has flagged two observations at Alembic Pharmaceuticals Ltd.’s Karkhadi facility in Gujarat.
The U.S. Food and Drug Administration has conducted an inspection at the company’s injectable facility (F-3) located at Karkhadi, Vadodara, from Aug. 18-30, 2022, according to an exchange filing. The regulator issued a Form 483 with two observations.
None of the observations are related to data integrity and are addressable, the company said in the filing. The company is preparing the response to the observations, which will be submitted to the U.S. FDA within stipulated period.
Vishal Manchanda, pharma analyst at Systematix, told BQ Prime that the plant is not operational yet and had received observations in October 2021.
Shares of Alembic Pharma fell nearly 1% intraday on Thursday. The stock was trading at 22.8x estimated forward earnings per share.
The scrip has underperfomed the benchmark so far in 2022, down 18.6% compared to 2.1% gain for the Sensex. The Relative Strength Index was 29, suggesting the stock may be ‘oversold’.
Of the 18 analysts tracking the company, two suggest a ‘buy’, six recommend a ‘hold’ and 10 maintain a ‘sell’, according to Bloomberg data. The 12-month consensus price target implies a 5.6% upside.