USFDA

MUMBAI: A US congressional panelhas voiced concern on the ineffective action on quality lapses taken by its national drug regulator Food and Drug Administration (FDA) particularly in manufacturing facilities in India and China. Together,…

Yatendra Kumar engaged in trading Wockhardt Ltd's shares while having access to unpublished price-sensitive information.Yatendra Kumar is also prohibited from buying, selling, or engaging in any transactions involving Wockhardt. The…

Gujarat based Concept Medical, a multinational medical devices company, has announced that it has received its fourth Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (USFDA) for the…

<!-- -->Metoprolol is used with or without other medications to treat high blood pressure (hypertension).Ahmedabad: Zydus Lifesciences on Thursday said it received final approval from the US Food and Drug Administration (FDA) to…

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MedTech solutions provider Xplore Health has received approval from the Indian Regulatory Authority CDSCO(Central Drug Standard Control Organization) for its medical watch CardiacSense. The approval came ahead of its commercial launch in…

Last Updated: February 20, 2023, 10:40 ISTOn conclusion of the inspection, Cipla has received eight inspectional observations in Form 483. (Representational pic/AP)Cipla will work closely with the USFDA and is committed to address these…

In a warning letter, the US Food and Drug Administration pointed out various lapses at the Halol plant which produces finished pharmaceutical products. | Photo Credit: Special Arrangement The U.S. health regulator has pulled up drug major…

The US health regulator has pulled up drug major Sun Pharma for manufacturing lapses, including failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products, at its Gujarat-based plant.…

MUMBAI: Pandemic preparedness and supply chain alignment will be the priorities in 2023 for the domestic pharma sector as the threat of a new variant of coronavirus looms large for several countries, including India. Medicines, boosters and…