Lupin gets EIR from USFDA for Nagpur facility
USFDA conducted the inspection between August 5-8, 2019, Lupin said in a filing to the BSE.
By PTI |
BCCL
New Delhi: Drug major Lupin on Friday said it has received an establishment inspection report (EIR) from the US health regulator after inspection of its Nagpur facility in Maharashtra.
The United States Food and Drug Administration (USFDA) conducted the inspection between August 5-8, 2019, Lupin said in a filing to the BSE.
The inspection for the oral solid facility closed without any Form 483 observation, it added. Form 483 notifies the company's management of objectionable conditions.
The Nagpur facility is the company's largest and most advanced oral solid dosage facility and has maintained a solid track record of compliance, Lupin said.
"Excelling at quality and compliance is one of our top priorities and we remain committed to meeting and exceeding standards set by regulatory agencies globally," Lupin MD Nilesh Gupta said.
Shares of Lupin were trading at Rs 740.30 per scrip on BSE, up 1.91 per cent from the previous close.
The United States Food and Drug Administration (USFDA) conducted the inspection between August 5-8, 2019, Lupin said in a filing to the BSE.
The inspection for the oral solid facility closed without any Form 483 observation, it added. Form 483 notifies the company's management of objectionable conditions.
The Nagpur facility is the company's largest and most advanced oral solid dosage facility and has maintained a solid track record of compliance, Lupin said.
"Excelling at quality and compliance is one of our top priorities and we remain committed to meeting and exceeding standards set by regulatory agencies globally," Lupin MD Nilesh Gupta said.
Shares of Lupin were trading at Rs 740.30 per scrip on BSE, up 1.91 per cent from the previous close.
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