Drug Approval | May 10, 2024
Cipla receives 1 observation from USFDA for Kurkumbh facility
The company is committed to address this observation comprehensively within stipulated time
The company is committed to address this observation comprehensively within stipulated time
Wacker Biotech US, a wholly owned subsidiary of Wacker Chemie AG, specializes in the microbial production of pDNA
FDA has concluded that this inspection is 'closed'
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The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
InvaGen has received 5 inspectional observations in Form 483
Eris Lifesciences enters into term loan agreement with Citi Bank
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
Cipla has received 8 inspectional observations in Form 483
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