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

    1108.70.00 (0.00 %)

    Updated - 27 July 2026
    1126.20day high
    DAY HIGH
    1106.00day low
    DAY LOW
    130501
    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

    Share this article: 

    Published Date : 12 Jun 2025

    Disclaimer :

    Investments in securities market are subject to market risk, read all related documents carefully before investing. This content is for educational purposes only. Securities quoted are exemplary and not recommendatory.


    The information on this website is provided on "AS IS" basis. Bajaj Broking (BFSL) does not warrant the accuracy of the information given herein, either expressly or impliedly, for any particular purpose and expressly disclaims any warranties of merchantability or suitability for any particular purpose. While BFSL strives to ensure accuracy, it does not guarantee the completeness, reliability, or timeliness of the information. Users are advised to independently verify details and stay updated with any changes. The securities are quoted as an example and not as a recommendation. Past performance is not necessarily a guide to future performance.

    The information provided on this website is for general informational purposes only and is subject to change without prior notice. BFSL shall not be responsible for any consequences arising from reliance on the information provided herein and shall not be held responsible for all or any actions that may subsequently result in any loss, damage and/or liability. Interest rates, fees, and charges etc., are revised from time to time, for the latest details please refer to our Pricing page.

    Neither the information, nor any opinion contained in this website constitutes a solicitation or offer by BFSL or its affiliates to buy or sell any securities, futures, options or other financial instruments or provide any investment advice or service.

    BFSL is acting as distributor for non-broking products/ services such as IPO, Mutual Fund, Insurance, PMS, and NPS. These are not Exchange Traded Products. For more details on risk factors, terms and conditions please read the sales brochure carefully before investing.



    Content Partner - Dalal Street Investment Journal Wealth Advisory Private Limited



    This article is for educational purposes only and should not be considered investment advice. Market investments are subject to risks. DSIJ Wealth Advisory Private Limited is a SEBI-registered Research Analyst (Reg. No: INH000006396) and Investment Adviser (Reg. No: INA000001142). Please consult your financial adviser before investing. 

    For more disclaimer, check here : https://www.bajajbroking.in/disclaimer

    Read More Blogs

    Our Secure Trading Platforms

    Level up your stock market experience: Scan the QR to download the Bajaj Broking App for effortless investing and trading

    QR code to download Bajaj Broking App

    9 lakh+ Users

    icon-with-text

    4.9 App Rating

    icon-with-text

    4 Languages

    icon-with-text

    ₹7,000 Cr+ MTF Book

    icon-with-text
    banner-icon

    Open Your Free Demat Account

    Enjoy low brokerage on delivery trades

    +91

    |

    Open Your Free Demat Account

    Enjoy low brokerage on delivery trades

    +91

    |