Glenmark Pharmaceuticals has been selling off assets to invest back into its focus areas, oncology, respiratory and dermatology. Now products from a couple of those areas are being recalled because they don’t feel right.
The FDA notes the Indian company is recalling more than 31,000 tubes of clotrimazole and betamethasone dipropionate cream because of consumer complaints the fungal fighter had a liquidity texture. The company blamed the problem on temperature control problems.
That voluntary recall came after Glenmark last month voluntarily recalled an undisclosed number of tubes of mometasone furoate cream because it was found to be gritty. That cream can be used as a skin treatment but also to prevent hay fever attacks.
Both products came out of the company’s plant in Baddi which has a history of these kinds of problems. The FDA in 2017 issued a Form 483 for the facility, pointing out it had received more than 20 complaints about a cream that buyers said was watery. Warehouse records showed that the drug had been stored for more than 30 hours at temperatures that ran as high as 112˚F, but the FDA said the company didn’t bother to investigate whether that might have been the cause of the texture issue.
The company has faced other manufacturing stumbles. In June, the FDA rejected Glenmark’s leading respiratory pipeline candidate, a nasal spray to treat seasonal allergic rhinitis, over manufacturing issues.
"The CRL cites deficiencies in the Drug Master File (DMF) pertaining to one of the active pharmaceutical
ingredients (APIs) and in the manufacturing facilities," the company said.
These kinds of missteps have contributed to Glenmark undertaking a debt restructuring as slow revenues and high capital expenses have been a drift anchor on its finances. It has already spun off its innovation and API businesses into separate entities. CEO Glenn Saldanha recently told investors the next step will be jettisoning some noncore assets, saying the company hoped to sell off about Rs. 800 crore ($110 million) this year.
“We’re still in discussions for a minority investor in API,” he said. “But the way to look at it is we also have a backup plan here. We are divesting a number of noncore assets.”