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Zydus Lifesciences Gets US FDA Clearance for Gujarat API Facility

Synopsis:

Zydus Lifesciences has secured a ‘No Action Indicated’ status from the US FDA for its Ankleshwar API unit. Despite weak net profit in Q4, US business revenue rose 24% YoY. Zydus Lifesciences share price closed at Rs.979.10, down 0.25%.


Zydus Lifesciences Ltd has received regulatory clearance from the United States Food and Drug Administration (US FDA) for its API manufacturing facility in Ankleshwar, Gujarat. The inspection was conducted between March 10 and March 14, 2025, and has been classified as ‘No Action Indicated’ (NAI). This means that the FDA did not find any objectionable practices, effectively closing the inspection process.

Also read: Sterlite Secures Rs.2,631 Crore BSNL Project in J&K and Ladakh

ZYDUS LIFESCIENCES LTD

Trade

969-9.79 (-1.00 %)

Updated - 13 June 2025
975.00day high
DAY HIGH
960.00day low
DAY LOW
326615
VOLUME (BSE)

Key Takeaways

  • The Ankleshwar unit inspection by US FDA concluded with an NAI status

  • US business revenue surged 24% YoY to Rs.3,130.7 crore in Q4 FY25

  • EBITDA grew 30% YoY to Rs.2,126 crore, with a margin expansion to 32.6%

  • Net profit fell 1% YoY to Rs.1,171 crore, impacted by a one-time loss

  • Zydus Lifesciences share price closed at Rs.979.10, down by Rs.2.50

Also read: Govt Halves Basic Customs Duty on Crude Edible Oils to 10%

Q4 Results Show Mixed Financial Performance

The company posted a marginal decline in net profit, down 1% year-on-year to Rs.1,171 crore for the March quarter. This fell short of market expectations, which estimated a profit of Rs.1,379.6 crore. The company faced a one-time loss of Rs.220 crore during the period.

Despite the bottom-line pressure, Zydus saw strong growth in its US formulation business, which contributes nearly 50% of its total revenue. Revenue from this segment stood at Rs.3,130.7 crore, up 24% year-on-year and 30% sequentially. In constant currency terms, it recorded $363 million in revenue—an increase from $285 million in the previous quarter.

Performance Snapshot – Q4 FY25

Metric

Q4 FY25

Q4 FY24

YoY Change

Net Profit

Rs.1,171 crore

Rs.1,182 crore

-1%

Revenue (US Formulation)

Rs.3,130.7 crore

Rs.2,524.8 crore

+24%

EBITDA

Rs.2,126 crore

Rs.1,630.5 crore

+30%

EBITDA Margin

32.6%

29.5%

+310 bps

Zydus Lifesciences Share Price (BSE)

Rs.979.10

-0.25% on the day

Revenue Growth Driven By US Market And New Launches

The company's growth momentum was largely powered by higher volumes and new product launches in the US market. The India branded formulations segment also recorded double-digit growth, outperforming overall market trends. These gains helped balance out the impact of the one-time loss on overall profitability.

With the FDA clearance, Zydus strengthens its regulatory credibility and operational continuity in the US market—a critical growth territory for the company. The clearance also enhances trust in the Ankleshwar API facility, reinforcing supply assurance to partners and regulators.

Despite the mild dip in Zydus Lifesciences share price, the regulatory development and strong operational performance in the US segment suggest a stable outlook for the company’s core businesses going forward.

Also read: Nazara Technologies Gets Rs.2,384 Cr Open Offer at Rs.990/Share

Source: CNBCTV18

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