Solara Achieves Flawless US FDA Inspection, Bolstering Global API Manufacturing Capabilities

Solara Active Pharma Sciences Limited (Solara), a leading pure-play Active Pharmaceutical Ingredient (API) provider, announced a significant milestone with the successful completion of a US Food and Drug Administration (US FDA) inspection at its new, state-of-the-art multipurpose API manufacturing facility in Visakhapatnam, Andhra Pradesh. This achievement underscores Solara’s unwavering commitment to quality and compliance in its API manufacturing operations.

Flawless Inspection Results

The US FDA inspection, conducted by a designated investigator from May 14th to 17th, 2024, yielded exceptional results. Solara’s Visakhapatnam facility received a clean bill of health, achieving an “Acceptable State of Compliance” with Zero Form 483 inspectional observations. This outcome signifies that the facility met all US FDA regulatory requirements, demonstrating Solara’s dedication to maintaining the highest quality standards throughout its manufacturing processes.

Greenfield Project with Advanced Capabilities

Solara’s Visakhapatnam facility, built on a greenfield site encompassing 40 acres, represents a significant investment in the company’s future. This advanced facility houses dedicated production lines for Ibuprofen API, a key pharmaceutical ingredient.

Furthermore, the Visakhapatnam site boasts backward integration capabilities, allowing Solara to manufacture its own key starting material for Ibuprofen production. This strategic move strengthens Solara’s supply chain resilience and ensures business continuity for its valued customers. Beyond Ibuprofen, Solara has initiated validation processes for other APIs at the Visakhapatnam facility, paving the way for future registrations in various regulated markets worldwide.

Expanding Footprint and Commitment to Compliance

With the successful US FDA inspection at the Visakhapatnam facility, Solara now boasts two FDA-inspected manufacturing sites for Ibuprofen drug substance – Puducherry and Visakhapatnam. This expanded footprint strengthens Solara’s position as a reliable and high-quality API provider, catering to a global clientele. Looking ahead, Solara remains steadfast in its commitment to maintaining the highest levels of compliance across all its manufacturing facilities, ensuring consistent quality and regulatory adherence for its entire API portfolio.

“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. This continues to demonstrate our relentless focus on world-class quality and compliance, which remains a key pillar of our growth strategy. 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,.” said Poorvank Purohit, MD and CEO.

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