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
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx
The company received seven observations in the Form-483
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials
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 collaboration furthers AstraZeneca’s presence in China following the $2.5bn investment in Beijing
Now approved for both acute and chronic HCV in adults and children aged 3 and above
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