Drug Approval | August 19, 2022
Lupin receives approval from U.S. FDA for Rufinamide Tablets USP
The product will be manufactured at Lupin's facility in Goa, India.
The product will be manufactured at Lupin's facility in Goa, India.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
The estimated capex is to the tune of Rs. 140 crore to be funded through debt and internal accrual
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
The product will be manufactured at Lupin’s facility in Goa, India.
Investment in response to increased demand for North American-based chemistry services
EBITDA stood at Rs. 39.9 crore and EBITDA margin for the quarter was 38.2% whereas Profit After Tax (PAT) stood at Rs. 17.5 crore translating into a PAT margin of 16.7%
Margins under pressure - Price erosion, shelf stock adjustments and inventory pare down in US biz impacted margins.
The inspection concluded with four Form 483 observations. None of the observations were related to data integrity.
The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR
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