Glenmark’s Ankleshwar plant gets US FDA clearance
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Mumbai: Glenmark Pharmaceuticals Ltd’s plant at Ankleshwar, Gujarat, which was found by the US drugs regulator to have violated certain manufacturing norms in December, has now been cleared by the US Food and Drug Administration (FDA).
“The Ankleshwar plant has received EIR (establishment inspection report) yesterday (14 March, 2017). The EIR is issued by the FDA only if it finds the facility to be deemed acceptable,” Glenmark said in a stock exchange filing on Wednesday.
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On Thursday, shares in the drugmaker rose 1.11% to close at Rs900.80 on the BSE, while the benchmark Sensex shed 0.15% to end at 29,398.11 points.
Glenmark sources active pharmaceutical ingredients (APIs) from its Ankleshwar unit for many of its crucial formulations that are supplied to the US market and, therefore, the clearance for this plant is a positive development, said an analyst, who did not wish to be named.
The US FDA had issued a Form 483 to Glenmark’s Ankleshwar plant with four observations relating to violation of good manufacturing practices after the inspection of the facility in December.
The US drug regulator issues a Form 483 if its investigators spot any conditions that in their judgement may constitute violations of the US Food, Drug and Cosmetic (FD&C) Act and related Acts.
In a stock exchange filing on 21 February, Glenmark had said it had responded to US FDA’s observations for Ankleshwar plant, giving details of its corrective measures in January.