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Zydus Lifesciences Gets Clean USFDA Report for Ahmedabad SEZ-II Unit

Zydus Lifesciences
Zydus Life may acquire a controlling stake in Ardelyx or buy key molecules.

Zydus Lifesciences has added another regulatory milestone to its record, securing a clean USFDA report for its Ahmedabad SEZ-II facility. The development comes just days before the company’s board meets to consider a Rs 5,000 crore fundraising plan.

The USFDA issued an Establishment Inspection Report (EIR) classifying the site as β€œNo Action Indicated” (NAI). This followed a Pre-Approval Inspection (PAI) conducted between 11th and 14th August, 2025. The inspection concluded with no observations, reaffirming the company’s strong compliance standards.

The positive outcome strengthens Zydus’ position as it prepares for its 6th November board meeting. During the meeting, they will discuss raising funds through options such as a QIP, rights issue, or private placement. Furthermore, a postal ballot process will also be initiated to seek shareholder approval.

Zydus will announce its July–September quarter results the same day. In Q1 FY26, it reported a 3.3% rise in net profit to Rs 1,467 crore. Revenue was up 6% year-over-year to Rs 6,574 crore, even as EBITDA margins narrowed slightly to 31.8%.

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