homenewsUSFDA concludes inspection at Ahmedabad facility of Zydus Lifesciences with zero observation
USFDA concludes inspection at Ahmedabad facility of Zydus Lifesciences with zero observation
On Tuesday, Zydus Lifesciences announced that it received final approval from USFDA for Varenicline tablets used in the treatment of smoking addiction.
Zydus Lifesciences Ltd recently announced that the United States Food and Drug Administration (USFDA) conducted an inspection at Zydus Biotech Park in Changodar, Ahmedabad from June 5 to June 13, and the inspection concluded with "nil observation".
This outcome signifies that the facility has met the standards set by the current Good Manufacturing Practices (GMP). The GMP ensures that manufacturing processes and facilities are designed, monitored, and controlled effectively, guaranteeing the production of safe and effective products that meet quality standards.
Additionally, Zydus Lifesciences announced on Tuesday that it has received final approval from the USFDA for Varenicline tablets, which are used in the treatment of smoking addiction. These tablets will be manufactured at the company's formulation manufacturing facility in Ahmedabad SEZ.
As of March 2023, Zydus Lifesciences has obtained a total of 374 approvals and has filed over 442 Abbreviated New Drug Applications (ANDA). In the financial results for the March quarter, the company reported a 25.36 percent decline in consolidated net profit, amounting to Rs 296.6 crore, compared to Rs 397.4 crore in the same period last year. However, the consolidated total revenue showed a significant increase of nearly 32 percent, reaching Rs 5,011 crore in the quarter under review, up from Rs 3,806 crore in the corresponding period last year.
At 10:48 AM, shares of Zydus Lifesciences were trading at Rs 519.45 apiece on BSE, reflecting a slight 0.34 percent increase.
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