Solara Active Pharma Sciences Ltd completes yet another USFDA Inspection with zero 483s

Published: Jan 28, 2019, 9:40 am IST

Solara Active Pharma Science Limited (Solara), a leading Active Pharmaceutical Ingredient provider today announced the successful completion of US FDA inspection at its manufacturing facility in Ambernath, Maharashtra with zero 483s inspectional observations.

Solara’s facility in Ambernath, Maharashtra is a multi-purpose API and intermediate facility. The facility can manufacture a wide range of complex APIs and advanced intermediates. It is equipped with clean rooms with a variety of isolation, drying, milling, and packaging equipment, company said in a filing with BSE.

This facility is also approved with EDQM.

Solara stays committed to demonstrating the highest level of compliance with yet another USFDA audit with ‘Zero 483s’. In Dec’18, the company also completed US FDA inspection at Solara Research Centre(SRC), Chennai with zero 483s.(UNI)