Solara’s Visakhapatnam Facility Achieves US FDA Compliance

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Solara's Visakhapatnam API facility passes US FDA inspection with zero observations, maintaining compliance. Spread across 40 acres, it specialises in Ibuprofen API production and key starting material, enhancing supply chain integration. Solara now has two FDA-inspected sites for Ibuprofen.

Solara Active Pharma News Today

Solara Active Pharma Sciences Limited announces the successful completion of the US Food and Drug Administration (US FDA) inspection at its multipurpose API manufacturing facility in Visakhapatnam, Andhra Pradesh.

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Zero Observations Outcome

The inspection, conducted from 14th to 17th May 2024, revealed an "Acceptable State of Compliance" with zero Form 483 inspectional observations, as stated by Solara in its filing to the stock exchange.

Site Overview and Specialization

Spread over 40 acres, Solara's Visakhapatnam facility is a green field project with dedicated facilities for Ibuprofen API manufacturing. Additionally, it produces key starting materials for Ibuprofen, ensuring backward integration of the critical supply chain.

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CEO's Statement

Poorvank Purohit, MD & CEO of Solara, expressed satisfaction with the inspection outcome, highlighting it as the second successful US FDA inspection at the site. He emphasised the company's commitment to maintaining the highest compliance standards across its manufacturing facilities.

Expansion and Regulatory Approvals

Solara's Visakhapatnam facility is not only focused on Ibuprofen API but is also engaged in validating other APIs for registration in various regulated markets globally. The company's six manufacturing facilities and R&D Centre have approvals from international regulatory agencies including US FDA, MFDS, EDQM, PMDA, and WHO.

Future Outlook

With this successful inspection, Solara strengthens its position as a leading API provider, ensuring business continuity and reinforcing its commitment to quality and compliance amidst evolving regulatory requirements. The company remains focused on sustaining its quality culture and further anchoring compliance efforts.

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