Drug Approval | June 19, 2023
Lupin receives EIR from FDA for its API manufacturing facility in Vizag
The inspection closed with the facility receiving an inspection classification of NAI
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)
Agreement provides customers in the majority of Europe* access to supply through Univar Solutions distribution network
Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)
Hampton joins PCC from Accord Healthcare, where he was the President and responsible for accelerating the firm's growth strategy
In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone
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