Drug Approval | July 04, 2023
Lupin receives approval from FDA for Cyanocobalamin Nasal Spray
Cyanocobalamin Nasal Spray (RLD Nascobal) had estimated annual sales of USD 69 million in the U.S. (IQVIA MAT Mar 2023)
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
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
The application is in line with Innocan's strategy to expand the scope of its combined magnesium and cannabis topical solution
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)
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