Zydus said that the inspection was closed with three observations from USFDA. The drug company assured that it is confident of addressing and resolving the issues to the satisfaction of USFDA.
?We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of Good Manufacturing Practices across our network?, Zydus said in a press release.
The pharmaceutical company in an exchange filing yesterday announced that it received final approval from the U.S. Food and Drug Administration (USFDA) to market Nitroglycerin Sublingual tablets. The drug is used to relieve chest pain (angina) in people who have a certain heart condition (coronary artery disease). It may also be used before physical activities to help prevent chest pain. Nitroglycerin belongs to a class of drugs known as nitrates.
Zydus Lifesciences (formerly known as Cadila Healthcare) is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
On a consolidated basis, (company name) net profit fell 5.08% to Rs 500.40 crore on 0.61% increase in revenue from operations to Rs 3,655 crore in Q3 FY22 over Q3 FY21.
Shares of Zydus Lifesciences were trading 1.81% higher at Rs 366.35 on BSE.
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