Lupin announced the successful completion of an inspection carried out by the US Food and Drug Administration (FDA) at its Nagpur, Maharashtra facility.
Lupin share price gained 2.4 percent intraday on Friday after the US health regulator concluded the inspection of company's Nagpur unit with zero observations.
Nagpur facility is the company's latest site and manufactures oral solid dosage products. The site also houses company's state of the art injectable manufacturing facility.
The pharma major announced the successful completion of an inspection carried out by the US Food and Drug Administration (FDA) at its Nagpur, Maharashtra facility.
"The inspection concluded without any observation. This inspection was a product specific pre-approval inspection," Lupin said.
Meanwhile, the company has received approval for its Atovaquone Oral Suspension USP, 750 mg/5 mL from the USFDA to market a generic version of GlaxoSmithKline LLC's Mepron Oral Suspension, 750 mg/5 mL.
The drug is indicated for prevention and acute oral treatment of mild-tomoderate Pneumocystis carinii pneumonia (PCP) in patients intolerant to trimethoprim-sulfamethoxazole (TMP-SMX).
Atovaquone Oral Suspension had annual sales of approximately $117.4 million in the US (as per IQVIA MAT's June 2018).
At 11:39 hours IST, the stock price Lupin was quoting at Rs 969.80, up Rs 13.45, or 1.41 percent on the BSE.