It has been another tough week for some of India's troubled drugmakers. Wockhardt, which has two plants banned by the FDA, saw its hopes stymied for getting export approval for a different facility that it had hoped could help it recoup some of its lost U.S. revenues. And India's Ipca Laboratories, which has three plants on the import alert list, said Monday it has now gotten a warning letter for the facilities.
The FDA has again found a lot that it doesn't like about a Chinese drugmaker. The agency has followed up an import alert against Chan Yat Hing Medicine Factory's drugs and cosmetic products with a warning letter.
The FDA indicated in a warning letter this week that Sun Pharmaceutical has some gaps in its manufacturing processes at its Halol plant, as well as leaks in the ceiling, that put its drugs at risk for contamination.
The FDA has followed up a warning letter it issued to Pan Pharmaceuticals with an import alert that effectively extends a ban on the drugmaker's products in the U.S.
When Dr. Reddy's acknowledged last month that it had received a warning letter for three of its Indian plants, it proclaimed it was "actively engaged" with the FDA to resolve the issues. But an FDA warning letter posted last week says that even after the company responded 9 times to the host of observations, the agency has not been assured it is on top of serious problems which included the discovery of a previously undisclosed testing lab.
Dr. Reddy's has been investing in more automated plants in hopes of impressing the FDA and avoiding the kinds of regulatory actions that have sidelined competitors' plants. It didn't work out like the Indian drugmaker had hoped. Last week, the FDA sent the drugmaker a warning letter for three of its plants.
An Indiana aspirin and acetaminophen producer closed up production last year for lack of funds, but the FDA is making sure that it doesn't open back up again without meeting basic standards after the agency found it using slipshod manufacturing methods and producing OTC pain meds that failed to meet standards on just about every measure.
Novartis said on Tuesday in its earnings announcement that two Sandoz plants in India had been nailed last week with a warning letter. CEO Joseph Jimenez said the FDA issued the warning letter for the sites in Kalwe as well as one in Turbhe, a plant that Sandoz intends to close.
The FDA issued a warning letter last year to PharMEDium Healthcare Holdings, the large compounding pharmacy operation that AmerisourceBergen said last week it would buy for $2.6 billion. But it turns out that FDA inspectors were back at the compounder's Cleveland center more recently and found that some problems with sanitation have yet to be resolved, while noting new issues.
The Chinese half of a Pfizer joint venture has found itself crosswise with the FDA, which has banned products from one of its plants and written it up in warning letter.