News | May 11, 2022
Aurobindo Pharma Ltd gets 6 observations from USFDA for Unit VII
The unit is an oral manufacturing facility at Jedcherla, Hyderabad
The unit is an oral manufacturing facility at Jedcherla, Hyderabad
The capex for FY22 stood at Rs 145 crore and is expected to be in the range of Rs 250-350 crore for the entire FY23 which would be funded through a mix of internal accruals and debt
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
Bora establishes a leadership position in Taiwan's CDMO sector as it continues to expand into the global CDMO market
The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
Recognition illustrates Takeda’s patient-centricity throughout its manufacturing and supply processes
Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)
Erytech is evaluating valuable strategic options to leverage its Erycaps platform and its development and manufacturing capabilities with complementary assets and/or a broader corporate transaction
Casper Pharma is a Hyderabad based SEZ company engaged in the formulations business. Post-purchase of shares, the target entity would become a wholly-owned subsidiary of SPL
WHO’s post EUA inspection found deficiencies in Good Manufacturing Practice at the facility
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