Zydus Lifesciences gets clean USFDA report for Ahmedabad SEZ-II facility

Zydus Lifesciences Ltd has received a clean report from the US Food and Drug Administration (USFDA) for its manufacturing facility at SEZ-II, Ahmedabad, the company informed in a stock exchange filing on Wednesday, November 5.The inspection — a Pre-Approval Inspection (PAI) — was conducted between 11 and 14 August 2025, and concluded with no observations.

The USFDA has issued an Establishment Inspection Report (EIR) classifying the facility as “No Action Indicated” (NAI), effectively closing the inspection.

Zydus said the outcome reaffirms its compliance standards and strengthens the company’s regulatory record, paving the way for future product approvals from the site. The disclosure was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
November 6 board meeting to consider fundraisingZydus Lifesciences will meet on 6 November to consider a proposal to raise up to ₹5,000 crore through the issue of eligible securities, which could include a qualified institutional placement (QIP), rights issue, preferential allotment, or private placement.

The company’s board will also consider initiating a postal ballot process to seek shareholder approval for the fundraising.

The pharmaceutical firm is also scheduled to announce its July–September quarter results on the same day.

In the first quarter of FY26, Zydus reported a 3.3% rise in net profit to ₹1,467 crore, supported by a forex gain of ₹57 crore. Revenue for the quarter grew 6% year-on-year to ₹6,574 crore, while EBITDA remained flat at ₹2,089 crore, and margins narrowed to 31.8% from 33.6% a year earlier.