FDA’s NME approvals declined substantially in 2022, causing overall New Drug Application (NDA) approvals to drop
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
The observations are procedural in nature
Biocorp will receive an initial milestone payment this year
Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.
Kyndryl's multi-cloud management solution leverages AI-based, cloud-hosted models to provide real-time metrics, events, logs, and traces
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
The audit was commenced for newly renovated manufacturing Block 1, Block 2, and Block 3
With the recent sales force expansion and new product launches, we expect to be back to above-market growth
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