Categories: US FDA Approval

Lupin’s Inhalation Research Center, Florida receives EIR from U.S. FDA

Mumbai, March 30, 2020: Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Inhalation Research Center located at Coral Springs, Florida. The facility was inspected by the U.S. FDA, between February 19, 2020 and February 26, 2020, on behalf of the U.K. MHRA for Lupin’s generic Fostair application to the U.K. MHRA.

Lupin’s Inhalation Research Center at Coral Springs, Florida, inaugurated in August 2015, focuses on research and development of respiratory products for the treatment of asthma, chronic obstructive pulmonary diseases and other respiratory ailments.

Commenting on the receipt of the EIR, Vinita Gupta, CEO, Lupin said, “The Inhalation Research Center at Florida was established to develop quality respiratory products to benefit patients across the U.S. and other advanced markets. The receipt of the EIR with satisfactory VAI status validates our commitment towards ensuring the highest levels of quality and CGMP compliance at all our sites. We are grateful for the U.S. FDA’s confidence in our team during this critical juncture in the fight against COVID-19, when it has become imperative that we focus on bringing high quality respiratory products to market.”

Corporate Comm India (CCI Newswire)

The Pharma Times News Bureau

Recent Posts

8 Ways Insomnia Affects Skin Health & How To Avoid It

By Dr. Priyanka Kuri, Consultant - Dermatology, Aster Whitefield Hospital, Bengaluru Insomnia, the persistent inability…

1 day ago

Breaking New Ground in Migraine Care: A Landmark Session on Diagnosis and Treatment

Illuminating Latest Advances in Migraine Diagnosis and Treatment New Delhi, December 21, 2024: In a…

1 day ago

Healthcare Startups to Watch Out for in 2025

New Delhi, December 20, 2024: The healthcare sector is undergoing a transformation fueled by technological…

2 days ago

DKMS’s First Global Impact Report of 2023 Serves as New Ray of Hope for Blood Cancer Patients Worldwide

National, December 20, 2024: DKMS just published its first Global Impact Report that outlines the organization's…

2 days ago

Sterling Biotech to start world’s first precision fermentation-based dairy protein factory in Gujarat

Ahmedabad, December 19, 2024: Sterling Biotech Limited, a joint venture between Perfect Day and Zydus, has…

3 days ago

Pioneers in Senior Care, Antara, Partners with Leading Diagnostics Player Dr. Lal PathLabs to Strengthen its Geriatric Care Services

New Delhi, December 19, 2024: Antara Senior Care, an integrated eco-system provider for lifestyle and…

3 days ago