Browsing Tag
Form 483
7 posts
Aurobindo Pharma (NSE: AUROPHARMA) shares slide after FDA flags compliance gaps at Telangana unit
Aurobindo Pharma shares fell after the US FDA flagged nine issues at a Telangana plant. Find out what it means for compliance, investors, and the stock outlook.
Solara Pharma’s manufacturing site garners positive FDA review
Solara Active Pharma Sciences Ltd’s (Solara Pharma) manufacturing facility in Cuddalore has garnered approval from the US Food…
US FDA issues Form 483 to Alkem Laboratories for St. Louis manufacturing plant after pre-approval inspection
US FDA issues Form 483 to Alkem Laboratories’ St. Louis plant after a pre-approval inspection. Learn what this means for its US market plans.
FDA inspection at Zydus Lifesciences’ Moraiya facility results in four Form 483 observations
US FDA issues four Form 483 observations at Zydus Lifesciences’ Moraiya plant; company commits to corrective action while confirming no data integrity concerns.
Alkem Laboratories issued FDA Form 483 for St. Louis facility
Alkem Laboratories Limited said that it has been issued Form 483 from the US Food and Drug Administration…
Glenmark Pharmaceuticals receives FDA Form 483 with 17 observations for North Carolina facility
Glenmark Pharmaceuticals, a global pharmaceutical company based in India, announced that it has been issued Form 483 with…
Alkem Laboratories gets Form 483 from US FDA for St. Louis plant
Alkem Laboratories said that the US Food and Drug Administration (FDA) has issued Form 483 to the company…