FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets
The TGA approval marks a pivotal step in Rusan Pharma’s expansion into the Australian market
The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market
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 GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
The recognition from Malaysia's NPRA, a member of PIC/S, opens doors to new global business opportunities
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
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