USFDA concludes inspection at Lupins Madhya Pradesh unit with no observations, stock gains over 2%
In July, the pharma company announced that the US drug regulator inspected its Nagpur oral solid dosage facility from July 3 to July 11, 2023. The inspection was closed with the issuance of a Form-483 with two observations.
Global pharma major Lupin gained more than 2 per cent in trade on Monday after the company announced that the United States Food and Drug Administration (USFDA) has completed inspection at its manufacturing facility at Mandideep in Raisen district of Madhya Pradesh with no observations.
The Good Manufacturing Practice (GMP) inspection was conducted between August 7 and August 11, 2023, and concluded without any observations, Lupin said in a disclosure to the stock exchanges on Saturday.
A Good Manufacturing Practices certificate is issued for plants that assure proper design, monitoring, and control of manufacturing processes and facilities. It ensures that each batch of products meets quality standards so that consumers know they are both safe and effective.
"The USFDA inspection of our Mandideep Unit-2 facility concluded with no observations. This further reaffirms our commitment to superior quality and compliance standards,” Nilesh Gupta, Managing Director, Lupin, said.
USFDA inspection of Nagpur facility
In July, the pharma company announced that the US drug regulator inspected its Nagpur oral solid dosage facility from July 3 to July 11, 2023. The inspection was closed with the issuance of a Form-483 with two observations.
The company had assured that it would address the observations raised, and would work with the USFDA to resolve them at the earliest.
Last week, the pharma company announced that its subsidiary Novel Laboratories Inc, based in Somerset, New Jersey, United States, received approval from the USFDA for Fluocinolone Acetonide body oil, which is used to treat skin problems.
Before that, Lupin received clearance from the USFDA for a new drug application for fluocinolone acetonide topical scalp oil.
Mumbai-headquartered Lupin develops and commercialises a wide range of branded and generic drugs in over 100 markets in the United States, India, South Africa, and across the Asia Pacific, Latin America, Europe, and Middle East regions.
It has 15 manufacturing sites, 7 research centres and the pharma company employs more than 20,000 professionals across the world.
Shares of Lupin were at Rs 1091.25 apiece, up 1.33 per cent, on BSE at 12:25 pm.
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