May 20, 2023 Source: drugdu 117
Global drug giant Pfizer is warning physicians and clinicians in India to immediately stop using four of its antibiotics due to manufacturing issues at a contract producer.The warning covers Magnex, Zosyn, Magnamycin and Magnex Forte.
All four products treat infections, with Zosyn used to target various infections caused by bacteria including stomach infections, skin infections, pneumonia, and severe uterine infections. Magnamycin injections and Magnex Forte are also used to treat bacterial infections.
The company issued the warning because of “deviations” at a manufacturing facility operated by Astral Steritech Private Limited, according to a letter shared on Twitter by Dr. Sudhir Kumar, M.D., of Apollo Hospitals in Hyderabad.
“Whilst the manufacturer is currently investigating the matter, they have requested Pfizer, as an abundant precautionary measure and as per best practices, to temporarily suspend the sale/distribution/supply and use of the aforementioned products, pending the investigation by the manufacturer,” the company said in its letter.
Pfizer added that it's taking "all reasonable efforts" to resolve the situation.
Astral Steritech Private Limited is based in Gujarat, India. In 2021, the company sold itself to Centrient Pharmaceuticals.
At the time of the deal, Centrient said Astral brought in-house production capacity for antibiotics at two FDA-approved production lines.
Reference: https://www.fiercepharma.com/manufacturing/pfizer-puts-kibosh-4-antibiotics-india-due-manufacturing-issues
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