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What is the story about?
Zydus Lifesciences said on Monday, September 28, a US Food and Drug Administration (USFDA) inspection at its manufacturing facility at SEZ II, Ahmedabad, has concluded with one observation.
The current Good Manufacturing Practices (cGMP) inspection was conducted from September 21 to September 28, 2026, according to an exchange filing on Monday.
Zydus Life said the inspection concluded with one observation and that there were no data integrity-related observations, adding that it will work closely with the USFDA to address the observation expeditiously.
Just two days earlier, Zydus Lifesciences said a separate USFDA inspection of its pharmacovigilance and post-marketing surveillance system at its New Jersey office had concluded with nil observations . The inspection was conducted from September 22 to September 25, 2026.
The company has also received regulatory approvals for new products in the US market. In August, Zydus received final USFDA approval for its generic version of Ascorbic Acid Injection, a product with annual US sales of around $11.6 million.
The approval covered two strengths of the injection, with the company also saying the application was designated as a Competitive Generic Therapy, making it eligible for potential 180-day exclusivity.
In its June-quarter results, Zydus Lifesciences reported a 35.9% year-on-year decline in profit to ₹939.8 crore, while revenue rose 22% to ₹8,017 crore. Earnings before interest, taxes, depreciation and amortisation (EBITDA) fell 7.6% to ₹1,929.4 crore, with the EBITDA margin contracting to 24.1% from 31.8% a year earlier.
North American formulations sales declined 2.6% year-on-year but rose 4.9% sequentially to ₹3,098 crore, driven by sustained volume growth and new launches, according to the company.
Zydus had also said its India branded formulations business continued to grow strongly and outpace the market, while its international markets and consumer wellness businesses maintained their growth momentum.
Shares of the company ended 0.6% higher at ₹1,211.10 ahead of the announcement on Monday. The stock has advanced more than 32% so far in 2026 and about 22% over the trailing 12-month period.
The current Good Manufacturing Practices (cGMP) inspection was conducted from September 21 to September 28, 2026, according to an exchange filing on Monday.
Zydus Life said the inspection concluded with one observation and that there were no data integrity-related observations, adding that it will work closely with the USFDA to address the observation expeditiously.
Just two days earlier, Zydus Lifesciences said a separate USFDA inspection of its pharmacovigilance and post-marketing surveillance system at its New Jersey office had concluded with nil observations . The inspection was conducted from September 22 to September 25, 2026.
The company has also received regulatory approvals for new products in the US market. In August, Zydus received final USFDA approval for its generic version of Ascorbic Acid Injection, a product with annual US sales of around $11.6 million.
The approval covered two strengths of the injection, with the company also saying the application was designated as a Competitive Generic Therapy, making it eligible for potential 180-day exclusivity.
Zydus Life Q1 results
In its June-quarter results, Zydus Lifesciences reported a 35.9% year-on-year decline in profit to ₹939.8 crore, while revenue rose 22% to ₹8,017 crore. Earnings before interest, taxes, depreciation and amortisation (EBITDA) fell 7.6% to ₹1,929.4 crore, with the EBITDA margin contracting to 24.1% from 31.8% a year earlier.
North American formulations sales declined 2.6% year-on-year but rose 4.9% sequentially to ₹3,098 crore, driven by sustained volume growth and new launches, according to the company.
Zydus had also said its India branded formulations business continued to grow strongly and outpace the market, while its international markets and consumer wellness businesses maintained their growth momentum.
Shares of the company ended 0.6% higher at ₹1,211.10 ahead of the announcement on Monday. The stock has advanced more than 32% so far in 2026 and about 22% over the trailing 12-month period.
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