US FDA flags ‘significant violations’ of CGMP norms at Gujarat-based Intas Pharma
The FDA asks the company to "correct any violations promptly", failing which the global agency may withhold approval of new applications or supplements listing
The FDA asks the company to "correct any violations promptly", failing which the global agency may withhold approval of new applications or supplements listing
Gamia's drug regulator introduces regulation of pre-shipment document verification, physical inspection, quality control testing, issuance of CRIA for pharmaceuticals