New Delhi: The US Food and Drug Administration (FDA) has highlighted Glenmark Pharmaceuticals Ltd’s inability to investigate batch failures at its manufacturing facility in Baddi, Himachal Pradesh.
“Product grittiness has been an ongoing formulation issue since 2010 and was a deficiency cited in the previous inspection of your facility," the US FDA said in its warning letter.
Glenmark had proposed specific remediation for the formulation issue in its response at that time, but the regulator called the response inadequate. The US FDA made the warning letter public on Tuesday.
US FDA’s comment refers to the failure of batches of anti-fungal topical cream that were manufactured at the Baddi facility. In July, the company had initiated a class 3 recall of the topical cream, a generic of Lotrisone cream, citing ‘temperature abuse’ and complaints from customers about the texture of the cream, as per information on the US FDA website.
In its warning letter, the US FDA said the company failed to timely recall and remake the topical cream. It also flagged the company’s delayed implementation of new shipping practices that protect products from temperature variations.
The Baddi facility had received a warning earlier this month after an inspection of the plant in April. Typically, new product approvals are not granted to units which are issued warning letter, even as existing imports from the unit are allowed.
However, Glenmark in its exchange filing earlier this month had said it did not expect a significant financial hit from the warning letter as there are no major pending product approvals from the facility in the next 12 months.
“We believe that the existing manufacturing and the sale of products from this facility will not be impacted. The Baddi facility is expected to contribute USD 30 mn in total sales for this financial year, which is approximately 7% of the total US sales," Glenmark had said in the filing.
In the June quarter, formulation sales to the US garnered Rs7.3 billion in revenue, nearly a third of Glenmark’s total consolidated topline of Rs23.2 billion.
The Baddi facility manufactures solid and liquid oral drugs, topical medicines like lotions and creams and respiratory segment products, as per information on the company’s website.
Shares of Glenmark Pharma were down 0.5% at ₹284.95 today on the National Stock Exchange.