FDA completes inspection of SMS Pharma’s Vizag facility
The inspection concluded with one minor observation in Form 483
The inspection concluded with one minor observation in Form 483
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
The company will respond to the US FDA within the stipulated timelines
The new site will produce next-generation synthetic medicine active pharmaceutical ingredients
The new site marks the company’s first operation in the region
Ipca Laboratories receives three observations from USFDA for API facility at Tarapur
Sun Pharma to set up Rs. 3,000 crore greenfield formulations facility in MP
The audit was completed with zero critical and zero major observations
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
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