Solara Active Pharma, a leading provider of Active Pharmaceutical Ingredients (API), has announced that the US Food and Drug Administration (USFDA) has completed its inspection of the company’s manufacturing facility in Visakhapatnam without any observations. The facility has now been rated as being in an ‘Acceptable State of Compliance’ by the US regulator.
“We are very happy with the successful inspection outcome of our Visakhapatnam API site with zero 483 inspectional observations. This is the second US FDA inspection we have undergone at this site,” stated Poorvank Purohit, Managing Director & CEO of Solara.
Solara Active Pharma operates two FDA-inspected manufacturing sites for Ibuprofen API, located in Puducherry and Visakhapatnam. The company remains committed to maintaining the highest compliance standards across all its manufacturing facilities. “We remain agile to the increasing requirements on quality and compliance, and I am confident that we will sustain our quality culture and anchor it further,” Purohit added.
The Visakhapatnam facility, a 40-acre greenfield project, is dedicated to the production of Ibuprofen API. It also manufactures key starting materials for Ibuprofen, achieving backward integration in its supply chain. This integration ensures greater control over quality and supply continuity, enhancing the company’s overall production efficiency.
The successful completion of the USFDA inspection without any observations underscores Solara’s commitment to stringent quality control and compliance with international regulatory standards. This achievement not only bolsters the company’s reputation but also assures its global clientele of its capability to consistently meet high-quality standards. The inspection outcome is a significant milestone for Solara Active Pharma, reinforcing its position as a reliable and compliant player in the global pharmaceutical industry.
