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Shares of Glenmark Pharmaceuticals were weak in trade on August 16 after the drugmaker was asked to recall 6.5 lakh tubes of a generic skin treatment drug.
According to an enforcement peport by the US Food and Drug Administration (USFDA), Glenmark on August 14 announced the recall of the drug because of manufacturing issues.
Also Read: Sun Pharma, Glenmark recall products in US due to manufacturing issues
Earlier in July, Glenmark Pharmaceuticals Inc, a wholly-owned subsidiary of Glenmark Pharma, initiated a nationwide Class III recall for Tacrolimus ointment used for treating eczema due to “defective container”.
Drug recall by manufacturers is expensive because of the additional costs involved, however, in instances of severe defects, it may also trigger a regulatory inspection of the manufacturing facility by the US drug regulator.
Glenmark’s stock has been a major underperformer in the pharma pack in 2022. The shares have fallen more than 26 percent this calendar year, largely due to a diminished outlook for the company’s earnings.
At 12.50 pm, Glenmark Pharma shares were down 0.4 percent at Rs 385 after falling over 1 percent earlier in the day on the National Stock Exchange.
The regulatory scrutiny of the Indian drug makers has increased in 2022, as the US FDA reconvened physical inspection of manufacturing sites outside the country, which was halted for two years on account of the COVID-19 pandemic.
In the last few weeks, several Indian drug manufacturers including Sun Pharma, Dr Reddy’s and Jubilant Cadista have been forced to recall drugs over various issues.
A PTI report citing USFDA said Sun Pharma was recalling 9,552 bottles of epilepsy drug Divalproex Sodium delayed-release tablets due to “failed dissolution specifications”. The recall was initiated in the US on June 27 this year.
Similarly, the US-based arm of Dr Reddy’s Laboratories is recalling 5,531 cartons of Lansoprazole delayed-release orally disintegrating tablets in two strengths due to failed dissolution specifications. The recall was initiated on July 13, the report said.
Jubilant Cadista Pharmaceuticals began recalling 38,160 bottles of Irbesartan Tablets (150 and 75 mg), used to treat high blood pressure, in mid-July.
Moneycontrol could not independently verify the report.
The US generic drug market was estimated to be around USD 115.2 billion in 2019 and is the largest for pharmaceutical products in the world.
