Axplora Announces Significant Investment at Vizag Site & FDA Inspection Success Across Indian Operations

Axplora recently announced a significant investment at its Vizag site in India to expand production capacity and reinforce supply chain resilience. This announcement follows the successful completion of routine USFDA inspections in 2025 at both of Axplora’s Indian manufacturing sites, Vizag and Chennai, which form part of the company’s PharmaZell Business Unit. Combined, these milestones underscore Axplora’s long-term commitment to India as a strategic pillar of its global operations and its dedication to maintaining world-class quality and compliance standards.

The expansion project at Vizag will increase output and create new employment opportunities, enhancing Axplora’s ability to meet growing global demand for high-value pharmaceutical ingredients. The investment also advances the company’s sustainability goals by supporting efficient, vertically integrated production at a single site.

“This investment reflects Axplora’s strategic commitment to operational excellence and customer-centric growth,” said Martin Meeson, CEO of Axplora. “By strengthening our infrastructure in Vizag, we are enhancing our ability to deliver high-quality, reliable, and scalable solutions to customers worldwide.”

Both the Vizag and Chennai sites successfully completed routine inspections by the US FDA in 2025, each concluding with a Voluntary Action Indicated (VAI) classification. These outcomes affirm the company’s robust compliance with international regulatory standards and its proactive approach to continuous improvement.

The inspector at the Chennai facility highlighted several areas of excellence, including the strong and consistent implementation of current Good Manufacturing Practices (cGMP), streamlined and efficient document management and retrieval processes, and the high standards maintained in facility upkeep and overall site hygiene.

“These results are a powerful validation of our team’s diligence and our unwavering focus on quality,” said Anant Barbadikar, Co-President of PharmaZell and Chief Operating Officer in India. “The success of both inspections reflects not just regulatory compliance, but the operational integrity and continuous improvement culture we strive to embed across every Axplora site.”

The company acknowledged the exceptional efforts of both site teams in preparing for and successfully navigating the inspections, and reaffirmed its commitment to proactively addressing the observations raised through robust corrective actions.

With enhanced capacity at Vizag and regulatory excellence demonstrated across both sites, Axplora continues to solidify its presence in India and its role as a trusted partner for the pharmaceutical industry worldwide.

Axplora is a trusted manufacturing partner to over 900 of the world’s leading pharmaceutical and biotech companies, formed from the integration of PharmaZell, Farmabios, and Novasep CDMO — three industry leaders with decades of experience in pharmaceutical manufacturing. Axplora delivers high-quality, reliable, and sustainable solutions across the pharmaceutical value chain.

With deep capabilities in complex chemistry and industrial manufacturing combined with an agile, explorer’s mindset, Axplora supports pharmaceutical and biotech companies in developing and producing life-changing therapies. PharmaZell and Farmabios are renowned for their expertise in active pharmaceutical ingredients (APIs), highly potent compounds, and regulatory excellence, while Novasep CDMO is a leader in small molecule and antibody-drug conjugates (ADCs) manufacturing while being a pioneer in purification technologies.

Axplora operates 9 API manufacturing sites across Europe and India, providing multi-site capacity to partners worldwide. For more information, visit www.axplora.com.