Jubilant Pharmova's Roorkee Facility Completes USFDA Pre-Approval Inspection with 4 Observations

1 min read     Updated on 02 Aug 2025, 07:33 AM
scanxBy ScanX News Team
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Overview

Jubilant Pharmova announced the completion of a USFDA pre-approval inspection at its Roorkee solid dosage formulations facility, operated by subsidiary Jubilant Generics Limited. The inspection, concluded on August 1, 2025, resulted in four observations. The company plans to submit an action plan to address these. Notably, the Roorkee site's US market revenue represents less than 1% of Jubilant Pharmova's total revenues for the July 2024 to June 2025 period.

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*this image is generated using AI for illustrative purposes only.

Jubilant Pharmova announced the completion of a pre-approval inspection (PAI) by the United States Food and Drug Administration (USFDA) at its solid dosage formulations facility in Roorkee, India. The inspection, which concluded on August 1, 2025, was conducted at the facility operated by Jubilant Generics Limited, a subsidiary of Jubilant Pharma Limited.

Inspection Outcome

The USFDA issued four observations following the audit. Jubilant Pharmova has stated that it will submit an action plan to address these observations. The company did not disclose the nature of the observations in its announcement.

Facility's Contribution to Revenue

In a notable disclosure, Jubilant Pharmova revealed that the Roorkee site's revenue from the US market represents less than one percent of the company's total revenues for the trailing twelve-month period from July 2024 to June 2025. This information suggests that while the facility is important for the company's US operations, its current financial impact is relatively small in the context of Jubilant Pharmova's overall business.

Company Background

Jubilant Pharmova Limited, formerly known as Jubilant Life Sciences Limited, is a global pharmaceutical and life sciences company. Its subsidiary, Jubilant Pharma Limited, is an integrated global pharmaceutical company engaged in various segments including:

  • Radiopharmaceuticals
  • Allergy Immunotherapy
  • Contract Manufacturing of Sterile Injectables and Non-sterile products
  • Solid Dosage Formulations

The company operates multiple manufacturing facilities catering to regulated markets, including the USA and Europe. With a team of around 5,500 multicultural employees across the globe, Jubilant Pharmova has established itself as a 'Partner of Choice' for leading pharmaceutical companies worldwide.

Implications and Next Steps

While the issuance of observations is a common occurrence in FDA inspections, it is crucial for pharmaceutical companies to address them promptly and thoroughly. Jubilant Pharmova's commitment to submitting an action plan demonstrates its proactive approach to regulatory compliance.

The company will likely focus on implementing corrective and preventive actions in response to the FDA's observations. The resolution of these observations will be important for maintaining the facility's good standing with the USFDA and ensuring continued smooth operations for US market supply.

Investors and stakeholders will be watching closely to see how quickly and effectively Jubilant Pharmova addresses these observations, as regulatory compliance is a critical factor in the pharmaceutical industry's operations and market access.

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Jubilant Pharmova Reports 10% Revenue Growth, Schedules Investor Meetings in Singapore

2 min read     Updated on 01 Aug 2025, 02:39 AM
scanxBy ScanX News Team
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Overview

Jubilant Pharmova reported a 10% year-over-year revenue growth to Rs. 1,901.00 crores for Q1 FY26. EBITDA increased by 14% to Rs. 302.00 crores, with margins improving to 15.8%. Normalized PAT grew by 48% to Rs. 103.00 crores. All business segments showed growth, with Radiopharmaceuticals generating Rs. 869.00 crores in revenue. The company announced upcoming investor meetings in Singapore on August 6, 2025, as part of the Nuvama India Conference, where it will meet with nine institutional investors. Jubilant Pharmova's Vision 2030 aims to double revenue, achieve 23-25% EBITDA margins, reach zero net debt, and attain high teens return on capital employed.

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*this image is generated using AI for illustrative purposes only.

Jubilant Pharmova , a diversified pharmaceutical company, has reported a 10% year-over-year revenue growth to Rs. 1,901.00 crores for the first quarter of fiscal year 2026. The company also announced upcoming investor meetings in Singapore as part of the Nuvama India Conference.

Financial Performance

The company's Q1 FY26 results showed solid growth across all business units:

Particulars (Rs. Cr.) Q1 FY26 Q1 FY25 Y-o-Y Change
Revenue 1,901.00 1,732.00 10%
EBITDA 302.00 266.00 14%
EBITDA Margin 15.8% 15.2% 60 bps
Normalized PAT 103.00 69.00 48%
Normalized PAT Margin 5.4% 4.0% 140 bps

The company's EBITDA margins increased year-over-year due to improved performance in CRDMO (Contract Research & Development Manufacturing Organization) and Generics segments. Normalized PAT (Profit After Tax) margins also saw an improvement, attributed to enhanced operating performance and reduced finance costs.

Business Segment Performance

Radiopharmaceuticals

The Radiopharmaceuticals segment, including Radiopharmacies, showed growth with Ruby-Fill® maintaining momentum. The segment reported revenue of Rs. 869.00 crores in Q1 FY26.

Allergy Immunotherapy

The Allergy Immunotherapy business saw year-over-year revenue growth, with EBITDA margins in the normalized range. The segment reported revenue of Rs. 181.00 crores in Q1 FY26.

CDMO Sterile Injectables

The CDMO Sterile Injectables segment reported revenue of Rs. 370.00 crores, with capacity expansion at the Spokane facility progressing ahead of expectations.

CRDMO

The CRDMO segment, comprising Drug Discovery Services and CDMO-API, reported combined revenue of Rs. 302.00 crores. The company continues to increase revenue share from large pharma clients in this segment.

Generics

The Generics segment showed improving growth and profitability outlook, reporting revenue of Rs. 166.00 crores in Q1 FY26.

Upcoming Investor Meetings

Jubilant Pharmova has scheduled investor meetings on August 6, 2025, in Singapore as part of the Nuvama India Conference. The company will meet with nine institutional investors, including:

  1. Lion Global Investor Ltd
  2. Tree Line Investment Management
  3. Templeton Emerging Markets Group
  4. Indea Capital Pte Ltd
  5. Persistence Capital
  6. Amansa Investment Advisors Pvt Ltd
  7. Ward Ferry Management Ltd
  8. Millenium Partners
  9. Capital Research

These meetings underscore the company's commitment to engaging with global investors and showcasing its growth strategy.

Vision 2030

Jubilant Pharmova has set ambitious targets for its Vision 2030:

  • Double revenue from current levels
  • Achieve 23-25% EBITDA margins
  • Reach zero net debt
  • Attain high teens return on capital employed

The company's Q1 FY26 results indicate progress towards these goals, with revenue growth and margin improvements across various segments.

Conclusion

Jubilant Pharmova's strong Q1 FY26 performance, coupled with its strategic investor engagements and clear long-term vision, positions the company for continued growth in the pharmaceutical sector. The diversified business model, spanning radiopharmaceuticals, allergy immunotherapy, CDMO services, and generics, provides multiple avenues for expansion and value creation.

Historical Stock Returns for Jubilant Pharmova

1 Day5 Days1 Month6 Months1 Year5 Years
-1.87%-2.38%-6.23%+6.66%+33.30%+35.19%
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