Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) to market Azilsartan Medoxomil and Chlorthalidone Tablets, 40 mg/12.5 mg and 40 mg/25 mg (USRLD: Edarbyclor tablets).
SOLANA BEACH, Calif. and AHMEDABAD, India, June 3, 2024 /PRNewswire/ -- Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (Zydus Group) today announced that it received accreditation from Great Place To Work®, the global management consulting firm that provides best-in-class data about the employee experience and establishes benchmarks for working conditions around the world.
Zydus, a leading discovery-based, global pharmaceutical company from Ahmedabad, has registered strong growth in net profit during the fourth quarter ended March 2024 with higher sales in US and launch of new products. Its consolidated net profit went up sharply by 299 per cent to Rs. 1,182 crore from Rs. 297 crore in the last period. Its revenues went up by 10.4 per cent to Rs. 5,534 crore from Rs. 5,010 crore. EPS of face value of share Re. 1 worked out to Rs. 11.69 as against Rs. 2.95 in the similar quarter of last year.
Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Theophylline Extended-Release Tablets, 300 mg and 450 mg (USRLD: Theo-Dur Extended-Release Tablets).
Zydus, a leading discovery-based, global pharmaceutical company, announced today that it has completed enrolment of its Phase II clinical study of NLRP3 inhibitor ‘Usnoflast (ZYIL1)’ in patients with Amyotrophic Lateral Sclerosis (ALS).
Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic Theophylline extended-release tablets used in the treatment of asthma and chronic obstructive pulmonary disease. The approval by the US Food and Drug Administration (USFDA) is for Theophylline extended-release tablets of strengths 300 mg and 450 mg, Zydus Lifesciences said in a regulatory filing.
Zydus receives final approval from USFDA for Dexamethasone Tablets
The Subject Expert Committee (SEC), which advises the Central drug regulator regarding clinical trials and approvals of drugs, has recommended approval for additional indication of Zydus Lifesciences' inactivated trivalent influenza vaccine in children above six months with clinical trial waiver subject to condition.
Following another citation at a different Zydus manufacturing site, the agency flagged 10 issues at a site in Gujarat, India.