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 approval confirms the facility's compliance with FDA quality standards and regulatory requirements
This is the first approval of a prescription transdermal dosage Form in the European markets from this facility
India has deep strengths in reverse engineering and API development, while Russia has strong capabilities in certain vaccines, biologicals, and niche therapeutic segments. Collaboration can significantly shorten R&D timelines
VitiPure serves as essential solubilizers, emulsifiers, and bioavailability enhancers in drug formulations
Ipca Laboratories receives three observations from USFDA for API facility at Tarapur
Granules Consumer Health serves as Granules’ front-end division for OTC products in the US
Implementing PFAS testing in the early development stages allows medical device manufacturers to prepare for potential regulatory updates
This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA
Subscribe To Our Newsletter & Stay Updated