Search For "usfda"
USFDA moves to accelerate biosimilar development and lower drug costs
Updated : 4 months, 2 weeks ago IST
The U.S. Food and Drug Administration (FDA) has announced major steps to make it faster and less costly to develop biosimilar medicines, lower-cost "generic" alternatives to biologic drugs used to treat serious and chronic diseases.
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Indian pharma sector to log 7-9% growth in FY26 despite US headwinds: ICRA
Updated : 5 months, 1 week ago IST
India's pharmaceutical industry is set to record healthy revenue growth of 7-9 per cent in FY26, even as challenges in the United States market continue to weigh on performance, noted rating agency ICRA in its latest sector outlook.
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Nureca Limited Reports 87% Growth for Q4 FY25, Expands Reach with Swiggy a
Updated : 10 months, 1 week ago IST
Mumbai (Maharashtra) [India], May 6: Nureca Limited, a leading player in the home healthcare and wellness industry, today announced its financial results for the fourth quarter and year ended March 31, 2025
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Zydus receives approval from the US drug authority to produce cholesterol-
Updated : 10 months, 2 weeks ago IST
Zydus Lifesciences Limited, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture Niacin Extended-Release Tablets.
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Rockwell Automation Empowers NKP Pharma Achieve Regulatory Compliance
Updated : 10 months, 3 weeks ago IST
New Delhi [India], April 21: Rockwell Automation, Inc. (NYSE: ROK), the world's largest company dedicated to industrial automation and digital, has successfully partnered with NKP Pharma, a leading manufacturer of pharmaceutical packaging machinery, to implement an advanced visualization sol
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'Zaynich' antibiotic for multi-drug resistant infections to get USFDA appr
Updated : 11 months ago IST
Zaynich is a novel antibiotic developed to target multi-drug-resistant Gram-negative infections.
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GoRoga Wearable: Revolutionizing Stress & Anxiety Management in India
Updated : 11 months, 2 weeks ago IST
Mumbai (Maharashtra) [India], April 1: In a groundbreaking discussion among leading psychiatrists in Mumbai, non-conventional approaches to stress and anxiety management took center stage. The spotlight was on GoRoga, India's first anti-stress wearable, which is redefining mental wellness th
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Veerhealth Care Successfully Completes USFDA Assessment of Form 4003 Pre-I
Updated : 1 year, 2 months ago IST
New Delhi [India], December 16: Veerhealth Care Ltd ((BSE: VEERHEALTH), AYUVEER, backed by Veerhealth Care's expertise in Ayurveda, specializes in crafting ayurvedic medicines and oral care products with natural ingredients. With a focus on quality and affordability, Ayuveer aims to offer
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Veerhealth Care Completes USFDA Assessment of Form 4003 FDA Pre-Inspection
Updated : 1 year, 3 months ago IST
Mumbai (Maharashtra) [India], December 13: Veerhealth Care Limited (BSE: VEERHEALTH), AYUVEER, backed by Veerhealth Care's expertise in Ayurveda, specialises in crafting Ayurvedic medicines and oral care products with natural ingredients. With a focus on quality and affordability, Ayuveer ai
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Rusan Pharma's API Plant in Ankleshwar Receives (India) USFDA GMP Approval
Updated : 1 year, 7 months ago IST
Ankleshwar (Gujarat) [India], July 22: RUSAN PHARMA PRIVATE LIMITED, a pharmaceutical company based in India specializing in the area of addiction treatment and pain management, recently announced that the United States Food and Drug Administration (USFDA) has granted Good Manufacturing Prac
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US FDA inspection closed at its Injectable Facility with Zero 483 observat
Updated : 1 year, 9 months ago IST
According to the stock market filing with the National Stock Exchange, the U.S. FDA carried out the inspection between June 10 to June 13, 2024, and concluded with zero 483 observations. The pharma major said in its filing, "The United States Food and Drug Administration (U.S. FDA) has compl
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Cipla secures USFDA approval for pancreatic disease injection, shares surg
Updated : 1 year, 9 months ago IST
Mumbai-headquartered pharma major, Cipla's US arm has secured final approval from the United States Food and Drug Administration (USFDA) for its Lanreotide Injection 120 mg/0.5 mL, 90 mg/0.3 mL, and 60 mg/0.2 mL.
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