Zydus Lifesciences Gets Clean USFDA Report for Ahmedabad Unit
ECONOMY & POLICY

Zydus Lifesciences Gets Clean USFDA Report for Ahmedabad Unit

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.

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.

Related Stories

Gold Stories

Next Story
Products

Koemmerling opens Navi Mumbai experience centre

Koemmerling, a brand of the profine Group, has expanded its presence in the Mumbai metropolitan region with the opening of a new experience centre in Navi Mumbai and launched its Allure S46 minimal sliding door system for the Indian market.Located in CBD Belapur, the facility was inaugurated by Peter Mrosik, Owner and CEO, profine Group, along with Farid Khan, Chairman and Managing Director, profine India, and Kamal Bajaj, CEO, profine India.The company said the new centre will showcase its portfolio of uPVC and aluminium window and door systems to architects, developers and homeowners.The ina..

Next Story
Products

India's waterproofing market nears Rs 150 bn milestone

India's waterproofing industry is approaching a market size of Rs 150 billion and is expected to surpass the $2 billion milestone, according to speakers at the 2nd India International Waterproofers Conference & Expo 2026 organised by the Waterproofers Association of India (WAI) in New Delhi.The two-day event brought together more than 20 speakers, 55 international delegates and 53 exhibition booths, with discussions focusing on climate-resilient construction, advanced waterproofing technologies and international collaboration.Inaugurating the event, Durga Shanker Mishra, former Secretary, ..

Next Story
Real Estate

Dilip Buildcon Q1 FY27 Revenue at Rs 23.78 billion

Dilip Buildcon Limited reported consolidated revenue from operations of Rs 2,378 crore in Q1 FY27, along with EBITDA of Rs 429 crore and profit after tax of Rs 128 crore.Consolidated EBITDA margin stood at 18.1%, improving from 17.1% in Q4 FY26. On a standalone basis, revenue from operations was Rs 1,930 crore, EBITDA stood at Rs 199 crore and PAT was Rs 39 crore, with an EBITDA margin of 10.3%.The company’s order book stood at Rs 27,691 crore as of 30 June 2026, compared with Rs 28,830 crore as of 31 March 2026. Roads and highways accounted for 17.1% of the order book, irrigation and water ..

Advertisement

Subscribe to Our Newsletter

Get daily newsletters around different themes from Construction world.

STAY CONNECTED

Advertisement