Axplora Announces €6.5 Million Investment at Vizag Site and FDA Inspection Success Across Indian Operations

5 August 2025 Axplora, a global leader in API small molecule manufacturing, today 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 Food and
Drug Administration (USFDA) 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

Press contact:

Will Frost (UK/US)
Phone: +44 (0)7799652421

Thomas Goldberg (Europe)
Phone: +33 (0)6 03 78 55 63

press@axplora.com
axplora.com