The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
The OAI classification implies that the US FDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
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.
Subscribe To Our Newsletter & Stay Updated
