Zydus Lifesciences Gets Clean USFDA Report for Ahmedabad Unit

07 Nov 2025 CW Team

The Pre-Approval Inspection (PAI) was conducted between 11 and 14 August 2025 and concluded without any observations. Following the inspection, the USFDA issued an Establishment Inspection Report (EIR), classifying the site as “No Action Indicated” (NAI) — effectively closing the inspection.

Zydus stated that the outcome reaffirms its strong compliance standards and enhances its regulatory track record, paving the way for future product approvals from the facility. The disclosure was made in line with Regulation 30 of SEBI’s Listing Obligations and Disclosure Requirements (LODR).

The company also announced that its Board of Directors will meet on 6 November to consider a proposal to raise up to Rs 50 billion through the issue of eligible securities. The fundraising options may include a qualified institutional placement (QIP), rights issue, preferential allotment, or private placement.

Additionally, the board will consider initiating a postal ballot process to seek shareholder approval for the proposed fundraising. The company 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 per cent rise in net profit to Rs 14.67 billion, supported by a foreign exchange gain of Rs 570 million. Revenue for the quarter grew 6 per cent year-on-year to Rs 65.74 billion, while EBITDA remained flat at Rs 20.89 billion. Profit margins stood at 31.8 per cent, compared with 33.6 per cent a year earlier.

The clean USFDA report is expected to further strengthen Zydus Lifesciences’ regulatory credibility and growth prospects in the US pharmaceutical market.

Zydus Lifesciences Ltd has received a clean report from the US Food and Drug Administration (USFDA) for its manufacturing facility at SEZ-II in Ahmedabad, the company informed in a stock exchange filing on Wednesday, 5 November. The Pre-Approval Inspection (PAI) was conducted between 11 and 14 August 2025 and concluded without any observations. Following the inspection, the USFDA issued an Establishment Inspection Report (EIR), classifying the site as “No Action Indicated” (NAI) — effectively closing the inspection. Zydus stated that the outcome reaffirms its strong compliance standards and enhances its regulatory track record, paving the way for future product approvals from the facility. The disclosure was made in line with Regulation 30 of SEBI’s Listing Obligations and Disclosure Requirements (LODR). The company also announced that its Board of Directors will meet on 6 November to consider a proposal to raise up to Rs 50 billion through the issue of eligible securities. The fundraising options may include a qualified institutional placement (QIP), rights issue, preferential allotment, or private placement. Additionally, the board will consider initiating a postal ballot process to seek shareholder approval for the proposed fundraising. The company 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 per cent rise in net profit to Rs 14.67 billion, supported by a foreign exchange gain of Rs 570 million. Revenue for the quarter grew 6 per cent year-on-year to Rs 65.74 billion, while EBITDA remained flat at Rs 20.89 billion. Profit margins stood at 31.8 per cent, compared with 33.6 per cent a year earlier. The clean USFDA report is expected to further strengthen Zydus Lifesciences’ regulatory credibility and growth prospects in the US pharmaceutical market.

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