Lupin receives tentative approval from USFDA for Obeticholic Acid Tablets
Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).
Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of US $255 million in the US (IQVIA MAT December 2022).
Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg, (RLD Rexulti) had estimated annual sales of US $1,575 million in the US (IQVIA MAT December 2022)
Rocuronium Bromide Injection had an annual sale of approximately US $53 million in the US (IQVIA MAT December 2022)
The one-year-long study was aimed to evaluate the efficacy of LDH's digital therapeutics platform
Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.
The inspection concluded with no observations
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
The approval for Glycopyrrolate clears the path for more internally manufactured injectable products
With the recent sales force expansion and new product launches, we expect to be back to above-market growth
DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- and middle-income countries
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