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Axplora Expands Vizag API Facility After Successful USFDA Inspections at Indian Sites

Axplora Expands Vizag API Facility After Successful USFDA Inspections at Indian Sites

Axplora, a global manufacturer of active pharmaceutical ingredients (APIs), has announced a major expansion at its Vizag facility in India to boost production capacity and fortify its supply chain.

The move comes after both of Axplora’s Indian manufacturing sites—Vizag and Chennai—operating under its PharmaZell Business Unit, successfully cleared routine inspections by the US Food and Drug Administration (USFDA) in 2025, receiving a Voluntary Action Indicated (VAI) classification. This status confirms compliance with regulatory standards and ensures continued operations without restrictions.

The investment in Vizag aims to meet rising global demand for high-value pharma ingredients, while advancing sustainability goals through vertically integrated production at a single site. The project is also expected to create new employment opportunities in the region.

“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.”

At the Chennai site, USFDA inspectors highlighted strong adherence to current Good Manufacturing Practices (cGMP), efficient document management, and high facility upkeep and hygiene standards.

“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.”

Axplora confirmed that any observations from the inspections will be addressed through corrective action plans. With expanded capacity in Vizag and validated compliance across both Indian facilities, the company is further strengthening its operational footprint in India as part of its global growth strategy for the pharmaceutical sector.

More news about: manufacturing | Published by Darshana | August - 06 - 2025 | 140

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