Drug Approval | June 17, 2025
USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
The company received one observation in the Form-483
The company received one observation in the Form-483
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities
The collaboration furthers AstraZeneca’s presence in China following the $2.5bn investment in Beijing
The project will be instrumental in enhancing the company's API manufacturing capacity and global reach
The company received 1 (One) observation in the Form-483
Zydus receives EIR for the API manufacturing facility at Ankleshwar
This strategic expansion marks a significant step in the company's global growth strategy
Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 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
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