Drug Approval | June 13, 2025
USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
The company received 1 (One) observation in the Form-483
The company received 1 (One) observation in the Form-483
Dilip Shanghvi to continue as the Executive Chairman of the Board
Zydus receives EIR for the API manufacturing facility at Ankleshwar
This strategic expansion marks a significant step in the company's global growth strategy
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
The use of Apisolex polymer excipient has been proven to increase the solubility of certain APIs by as much as 50,000-fold
Globally, BRUKINSA is approved in more than 70 countries
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)
If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference
The 16,000-square-foot expansion enhances DuPont’s global sterile operations
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