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US FDA Approves Zydus' Cevimeline Hydrochloride Capsules 30 mg
Zydus Lifesciences has received USFDA approval for Cevimeline Hydrochloride Capsules 30 mg for treating dry mouth associated with Sjögren’s syndrome. The capsules will be manufactured at the company’s SEZ-II facility in Ahmedabad.
Special Economic Zone | 13/03/2026 | By News Bureau | 159
Zydus Gets USFDA Tentative Nod for Dapagliflozin Tablets
Zydus has received tentative approval from the US Food and Drug Administration (USFDA) for dapagliflozin tablets in 5 mg and 10 mg strengths, paving the way for the company’s entry into the US market subject to final approval.
Special Economic Zone | 06/02/2026 | By News Bureau | 139
Zydus Gets USFDA Tentative Nod for Budesonide Delayed-Release Capsules, 4 mg
Zydus has received tentative approval from the US Food and Drug Administration (USFDA) for its Budesonide delayed-release capsules, 4 mg. The drug is indicated for the treatment of mild to moderate active Crohn’s disease affecting the ileum and/or ascending colon in adults and children aged eight years and above.
Special Economic Zone | 05/11/2025 | By Dineshwori | 311
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