Drug Approval | September 30, 2023
Lupin Receives EIR from U.S. FDA for its Nagpur Unit-1 manufacturing facility
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
Lupin has been exclusively marketing these brands in the Indian market since July 2021
This acquisition strengthens Lupin's commitment to providing superior treatment options for patients navigating the complexities of diabetes
The inspection was conducted from August 7 to August 11, 2023 and concluded without any observations.
Lupin has received US$ 25 million from AbbVie for initiation of Phase 1 clinical studies successfully
The partnership aims to prioritize the diagnosis and treatment of these diseases while working to reducing their long-term prevalence
The inspection closed with the facility receiving an inspection classification of NAI
The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
With the combination of oral solid, inhalation, dermatology, high potent and oral contraceptive products, this is an important facility of the company
Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.
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