Drug Approval | July 24, 2023
Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village
Aurobindo will respond to the US FDA within the stipulated timelines
Aurobindo will respond to the US FDA within the stipulated timelines
This product would be manufactured at Lupin's Nagpur facility in India
Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
This product will be manufactured at Lupin's Pithampur facility in India
The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S.
The inspection closed with the facility receiving an inspection classification of NAI
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