India’s Glenmark has been having its manufacturing problems, what with recalls and complete response letters (CRLs). Now, to round things out, the FDA has issued a warning letter for one of its key manufacturing facilities.
The drugmaker in a public filing said (PDF) the FDA has issued the warning letter for the company’s Baddi facility in Himachal Pradesh following an inspection that had initially resulted in a Form 483.
The drugmaker said it is responding and doesn’t believe the action will interrupt manufacturing at the facility or impact sales. Glenmark reported the facility, which accounts for about 7% of its U.S. sales, is projected to produce about $30 million in revenues for the company.
Glenmark didn’t indicate what the issues were, but the plant has a history of manufacturing problems. In August, it recalled more than 31,000 tubes of clotrimazole and betamethasone dipropionate cream because of consumer complaints the fungal fighter had a liquid texture. A month earlier, it voluntary recalled an undisclosed number of tubes of mometasone furoate cream because it was found to be gritty. Both products came out of the company’s plant in Baddi.
In 2017, the FDA 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 the drug had been stored for more than 30 hours at temperatures that ran as high as 112˚F, and the company didn't investigate whether that was the root cause of the texture issue.
Glenmark has had issues at other plants. The FDA issued a CRL in June for its New Drug Application for Ryaltris, a nasal spray to treat seasonal allergic rhinitis and Glenmark’s leading respiratory pipeline candidate. It said the CRL cites deficiencies in the Drug Master File relating to one of the active pharmaceutical ingredients as well as in the manufacturing facilities.