The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
With the combination of oral solid, inhalation, dermatology, high potent and oral contraceptive products, this is an important facility of the company
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)
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
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