Caplin Point’s Gummidipoondi Facility Receives US FDA Clearance

7 Jan 2025 , 12:07 PM

Caplin Point Laboratories Ltd notified that it has received an Establishment Inspection Report (EIR) from the US FDA for injectable and ophthalmic manufacturing facility in Gummidipoondi, Tamil Nadu. US FDA unannounced inspected Caplin Steriles between August 5-9, 2024.

The closing of inspection with no Form 483 observations was the pinnacle of compliance with US FDA standards. EIR established that the facility is compliant with GMP and other regulatory requirements. Caplin Point had earlier communicated with the stock exchanges on August 9, 2024 that the inspection had been completed with no major observations.

The US FDA inspection is an annual follow-up process intended to ensure whether or not facilities follow the quality and regulatory standards. This success reiterates the commitment of Caplin Point toward the best standards of manufacturing and adherence to regulations. The company had focused on high-quality pharmaceutical products along with the adherence to international standards of regulation.

This success laid a good base for Caplin Steriles in the pharmaceutical field and added muscle to its presence in international markets. The company has made this announcement on the basis of aligning international benchmarks and footprint expansion globally in the process of working.