Drug Approval | June 22, 2023
Lupin receives USFDA approval for Tiotropium Dry Powder Inhaler
This product will be manufactured at Lupin's Pithampur facility in India
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 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
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)
Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)
Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).
For the treatment of Superficial Femoral Artery
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