Two leading Indian drug firms once again face quality in manufacturing issues with the U.S. FDA, leading in this case to voluntary recalls even as both face extensive remedial actions to bring plants back into the good graces of the regulator.
India's Sun Pharmaceutical Industries and Wockhardt each recalled products voluntarily in the past month, the Economic Times reports.
In the case of Sun, multiple lots of antidepressant drug bupropion hydrochloride extended-release tablets were pulled after the U.S. FDA said they "failed dissolution specification," while Wockhardt yanked lisinopril tablets linked to good manufacturing practice violations, the Economic Times said.
In June, Wockhardt was on its third voluntary recall in as many months with 85,000 cartons of over-the-counter heartburn treatment famotidine tablets pulled, which followed statements from the company in April of problems with more than a dozen drugs manufactured at its two facilities in Aurangabad, India--Chikalthana and Waluj.
In August, reporting first quarter earnings, Sun said it has a plan for triage on four Ranbaxy manufacturing plants banned by the U.S. FDA in the past 5 years. And that may mean one unit may not make it, the Economic Times reported earlier. Sun bough Ranbaxy earlier this year.
The plan now is to get the plants in Mohali, Dewas and Toansa back online in an orderly fashion, placing a priority on Mohali, and leaving the plant in Paonta Sahib to take down its former lead role to the U.S. market and keep producing for other markets, including the World Health Organization as well as Europe and Australia, the Economic Times said earlier.
In addition to the Ranbaxy unit, a plant owned by Sun at Halol also has to clear U.S. FDA regulatory hurdles.
In the recall for Sun, the FDA labelled it a Class-III classification--or "'a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences," the Economic Times said, adding that as many as 35,235 bottles were subject to recall.
For Wockhardt, the recall of the hypertension drug comes after a class-II classification from the FDA, the Economic Times said, adding that was for "past market complaints" on manufacturing violations.
- here's the story from the Economic Times