Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
The company will provide the necessary response to USFDA within stipulated 15 days
The company will provide the necessary response to USFDA within stipulated 15 days
The proceeds from the QIP will be utiized for purchase of outstanding optionally convertible debentures
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials
SUP will obtain regulatory approvals for selling Tiotropium DPI in China
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression
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
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