The US Food and Drug Administration has cleared Solara Active Pharma Sciences Ltd's new multipurpose active pharmaceutical ingredient manufacturing facility at Visakhapatnam, Andhra Pradesh, with no observation, the company said in an exchange filing.
The inspection was carried out by the US drug regulator during Jan 23-26. The inspection established that the site is in an Acceptable State of Compliance and with Zero Form 483 inspectional observations from the agency.
The plant is a new construction project with specialised manufacturing facilities for the active medicinal ingredient in ibuprofen as well as a multipurpose facility in phase 1.
The institution has also begun verifying additional active pharmaceutical components in order to register in several globally regulated marketplaces.
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