April 25 (Reuters) - The U.S. health regulator has sent a warning letter to Cardinal Health (CAH.N), opens new tab after an inspection of its facility in Illinois found the company was marketing and distributing unapproved devices made by a Chinese manufacturer.
USFDA conducted an inspection at the Injectable Manufacturing site situated at Jarod, near Vadodara. The inspection was conducted from April 15 to April 23, 2024.
Jubilant Pharmova Limited today announced that the United States Food and Drug Administration (USFDA) has concluded audit of the Radiopharmaceutical manufacturing facility on April, 23, 2024 at Montreal, Canada of Jubilant Draximage, a subsidiary of its wholly owned subsidiary Jubilant Pharma Limited.
Dr. Reddy's Laboratories Ltd on Tuesday announced that it is voluntarily recalling six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg in the U.S. due to powder discoloration in some packets, leading to decreased potency
Aarti Drugs said in an exchange filing that the company has received five observations in Form 483 from the United States Food and Drug Administration after the agency inspected the formulations manufacturing facility of the company’s subsidiary Pinnacle Life Science at Baddi, Himachal Pradesh.
Biosplice’s osteoarthritis drug has failed a Phase 3 clinical trial, according to the drugmaker, significantly clouding the drug’s chances of approval and the future of a company that was once valued at $12 billion.
Novartis is “actively” managing its existing relationships with Chinese service providers to mitigate risks if the Biosecure Act passes.
Natco Pharma failed to maintain cleanliness, sterilise equipment and utensils at appropriate intervals at its Telangana-based plant, as per the US health regulator.
Marksans Pharma slipped 1.50% to Rs 173.85 after the United States Food and Drug Administration (US FDA) issued 5 observations in Form 483 after inspecting the company's Goa-based plant.
FDA classifies recall of Boston Scientific device as `most serious`