INDIA – The United States Food and Drug Administration (U.S. FDA) has issued an Establishment Inspection Report for Lupin’s manufacturing site in Mandideep in the Bhopal district of the Indian state of Madhya Pradesh.
Lupin received the EIR from the U.S. FDA for its Mandideep Unit-2 manufacturing facility after an inspection closed with the facility receiving an inspection classification of No Action Indicate (NAI).
The drug maker clarified that the EIR was issued after the last inspection of the facility conducted from August 7, 2023, to August 11, 2023.
In a press statement, Nilesh Gupta, the Managing Director of Lupin, said: “We are pleased to receive the EIR with a satisfactory inspection status from the U.S. FDA for the recent inspection of our Mandideep Unit-2 facility.”
In light of the EIR from the U.S. FDA for its Mandideep facility, it’s important to mention that Lupin’s Mandideep manufacturing facility completed a GMP inspection by the U.S. FDA.
The GMP inspection was conducted from August 7, 2023, to August 11, 2023, and concluded without any observations. It further reaffirms the company’s commitment to superior quality and compliance standards.
Commenting on the latest FDA inspection report, Nilesh Gupta said: “This accomplishment is in line with our continued focus and commitment to becoming best-in-class in quality and compliance, and enables us to continue delivering quality affordable healthcare solutions globally.”
Bearing in mind that Lupin recently received an EIR from the U.S. FDA for its Pithampur Unit-2 manufacturing facility that manufactures oral solids and ophthalmic dosage forms
The EIR was issued after the last inspection of the facility conducted from March 21, 2023, to March 29, 2023. The U.S. FDA determined that the inspection classification of the facility is Voluntary Action Indicated (VAI).
This news comes after the satisfactory evaluation of the corrective actions taken by the company in response to the Warning Letter that was issued on November 6, 2017.
Subsequently, Lupin received correspondence from the US FDA that it has now addressed the concerns raised in the Warning Letter for its facilities in Goa and Pithampur Unit-2, Indore.
It marks a significant milestone as Lupin builds back its reputation of being compliant with good manufacturing practices, upholding global quality standards, and ensuring the quality of its products.
Lupin gets FDA green light for its Nagpur manufacturing facilities
Lupin’s state-of-the-art injectable facility at Nagpur is designed to the highest quality standards and adheres to international regulations with advanced technology and equipment.
The EIR was issued post the last inspection of the Nagpur injectable facility conducted from October 17, 2022, to October 29, 2022.
Moreover, Lupin recently received an EIR from the United States Food and Drug Administration for its Nagpur Unit-1 manufacturing facility that manufactures oral solid dosage forms.
The EIR was issued post the last inspection of the facility conducted in July 2023. The U.S. FDA determined that the inspection classification of the facility is Voluntary Action Indicated.
Commenting on the EIR with a VAI status from the U.S. FDA, Nilesh Gupta underscored: “This achievement underscores our commitment to quality and compliance. It also mirrors our core values, reaffirming our commitment to providing high-quality healthcare solutions to our patients around the world.”
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