The product is a generic version of Sanofi Genzyme's Hectorol injection
Net profit stood at Rs 2.68 billion compared to Rs 4.53 billion in the year-ago period
Lupin's North American sales stood at Rs 12.48 billion, down 8.25 per cent from Rs 13.61 billion in July-September period of the last fiscal
The inspection at the site was conducted between October 8 and October 18, 2018
Lupin expects to make Aplevant available in India from October 2018, it said in a statement
The stock slipped 5% to Rs 821 on the BSE after the company reported 43% year-on-year drop in consolidated net profit at Rs 2.03 billion June quarter, hit by fall in sales in the US and Japan.
Analysts continue to be cautious, given the USFDA's warning letter to its plants at Goa and Indore, resolution of which is necessary to improve growth visibility
Lupin's Japan story assumes significance as it held on to the highly regulated market when most of its Indian peers quit
Hart will be based in Baltimore, Maryland in the US, and will report to Gupta
Total revenue from operations stood at 40.33 billion as against 42.533 billion in the year-ago period, Lupin said in a regulatory filing
While approvals will help it launch its drugs in the US market, clearance for its various units removes a potential overhang
The product is the generic version of Aton Pharma Inc's Lodosyn tablets in the same strength
The approved Tydemy tablets are generic equivalents of Bayer HealthCare Pharmaceuticals Inc's Safyral tablets, Lupin said
Lupin shall commence promoting the product shortly, it added
Lupin said its profit was hit by a foreign exchange loss of 821 million rupees compared to a gain of Rs 276 mllion a year earlier
Oseltamivir phosphate capsules are indicated for the treatment of influenza
Lupin shares were trading 2.47% up at Rs 899.15 apiece on BSE on Friday