The approved product has an estimated market size of around US$ 606 million for the twelve months ending June 2022, according to IQVIA.
The product will be manufactured at Lupin’s facility in Goa, India.
Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved in the US for children as young as five years of age
Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.
he US FDA has issued six observations pursuant to the completion of the audit.
The company has responded to the warning letter and carried out the committed corrections.
Strides is the first Indian company to get approval for the product.
The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.
The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing
The product will be manufactured at Lupin's facility in Nagpur, India.
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