Zydus Lifesciences announced that the US Food and Drug Administration (USFDA) has concluded its Pre-Approval Inspection (PAI) of the company’s SEZ II formulation manufacturing facility in Ahmedabad, with no observations. This clean report reinforces Zydus’ compliance with global standards, paving the way for expedited approvals and enhanced presence in the US market.
Zydus Lifesciences, a leading Indian global life sciences company, has successfully navigated the USFDA’s Pre-Approval Inspection process at its formulation manufacturing facility situated in SEZ II, Pharmez, Ahmedabad. The inspection, conducted from August 11 to 13, 2025, focused on three drug products as well as general current Good Manufacturing Practices (cGMP).
The inspection concluded with NIL observations, signifying the plant’s full compliance with USFDA standards and regulations. This outcome is a significant milestone, reflecting Zydus’ commitment to quality manufacturing and rigorous regulatory adherence, bolstering its credibility for approvals of Abbreviated New Drug Applications (ANDAs).
The Establishment Inspection Report (EIR) received by Zydus is a critical document that clears the way for the company to accelerate product launches and exports to the highly regulated US generics market. With over 380 approvals and more than 440 ANDAs filed since 2003, Zydus continues to expand its footprint in one of the world’s largest pharmaceutical markets.
The company emphasized that this clean inspection outcome aligns with its strategic vision to lead in quality healthcare manufacturing and expand global exports. Zydus also reassured investors and stakeholders about its robust compliance frameworks and ongoing efforts to address any observations in other facilities promptly.
This success also comes after notable financial performance, including a 3.3% rise in net profit to ₹1,467 crore in Q1 FY26, driven by operational efficiencies and forex gains. The company’s stock responded positively to the inspection news, appreciating in trading.
Zydus’ Ahmedabad SEZ II plant’s clean slate from the USFDA positions the company strongly to capture further market share in the US and strengthen its global portfolio, underscoring India’s growing stature as a reliable pharmaceutical manufacturing hub.
Key Highlights:
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USFDA Pre-Approval Inspection of Zydus Lifesciences SEZ II Ahmedabad formulation plant concluded with zero observations.
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Successful inspection clears regulatory hurdles for faster product approvals and enhanced US market access.
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Inspection covered three drug products and general current Good Manufacturing Practices (cGMP) compliance.
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Zydus holds over 380 ANDA approvals and continues active filings to grow US generics presence.
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EIR receipt marks a key regulatory milestone, boosting investor confidence.
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Company reported a 3.3% net profit increase to ₹1,467 crore in Q1 FY26, aided by forex gains.
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Positive market response follows regulatory success.
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Zydus strengthens position as a global pharmaceutical manufacturing powerhouse with high-quality standards.
Sources: NSE India, Medical Dialogues, Economic Times Pharma, Indian Pharma Post, CNBC-TV18
