FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe
Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
Jagsonpal Pharmaceuticals has received full consideration of Rs. 41 crore towards the sale of the facility and will now be proceeding with registration formalities
EBITDA for the quarter is Rs. 21.6 crore as against Rs. 18.1 crore in Q2 FY24
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
US Generics grew 5% to Rs. 467 Crores for the quarter
Revenue share from the North America increased to 79% in Q2 FY25 as compared to 67% in Q2 FY24
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
USFDA completes PAI of Lupin’s biotech facility in Pune
Subscribe To Our Newsletter & Stay Updated
