Glenmark's Ankleshwar plant gets USFDA clearance

Mumbai: Glenmark Pharmaceuticals Ltd’s active pharmaceutical ingredients (API) manufacturing plant at Ankleshwar in Gujarat, in which the US Food and Drug Administration (USFDA) had earlier observed certain violations of norms, has now been cleared by the US drug regulator.

“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.

Shares of the company rose on this announcement. At 9:50am, the stock was up 1.8% at Rs906.70 on the BSE, while the benchmark Sensex index was trading almost flat at 29,449.42 points.

Glenmark sources APIs from 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 USFDA 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 2016.

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 USFDA’s observations for Ankleshwar plant, giving details of its corrective measures in January.

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