India Pharma Outlook Team | Monday, 18 November 2024
India holds the biggest share in global generic medicine supply with 20 percent, producing 60,000 generic brands in 60 therapeutic categories. Products made in the country are sent to more than 200 countries worldwide, with Japan, Australia, Western Europe, and the United States being the primary places they are shipped to.
Dr Reddy's Laboratories and FDC Ltd are withdrawing generic drugs from the US market because of production problems, as reported by the US health watchdog. According to the most recent Enforcement Report from the Food and Drug Administration (USFDA), the US branch of Dr Reddy's Laboratories is recalling several different dosages of Morphine Sulfate extended-release tablets in the United States.
The drug is prescribed for the alleviation of intense and lasting pain. According to the USFDA, Dr Reddy's Laboratories Inc in Princeton is withdrawing 2,040 bottles of 15 mg Morphine Sulfate extended-release tablets because of "Failed Impurities/Degradation Specification".
The drug manufacturer is recalling 532 more 100-count bottles of the 30 mg strength medication for the same reason, according to the USFDA. Dr Reddy's started the nationwide Class II recall on October 22 of this year.
USFDA announced that FDC Ltd, based in Mumbai, is withdrawing 1,55,232 bottles of Timolol Maleate ophthalmic solution from the US market.
The company is issuing a recall for the impacted batch because of a "Faulty Container: Inability to dispense the solution from the bottle as the cap's spike is stuck in the product bottle's nozzle," according to the US health regulator.