India's Dr. Reddy's Laboratories is having to recall both an epilepsy drug and a combo cardiovascular drug all made in India. One, the FDA says, is too strong while the other is not strong enough. The recalls come even as the FDA has been paying special attention to generic equivalence after testing has found evidence that some generics are not measuring up.
China's Zhuhai United Laboratories bills itself as the world's largest manufacturer of the API for the antibiotic amoxicillin. But the sterile manufacturing for some of its amoxicillin products has been called into question by inspectors in Europe, which is banning the sterile drugs for now, except in limited cases.
When any member of the European Union finds issue with a drugmaker, it is reported to a central database to alert other members that might also buy from that facility. Now Slovenia has raised red flags about an Indian drugmaker it says it discovered during an inspection is not meeting cGMP standards.
Sterile injectable drugs are a growth area, but they are notoriously tricky to manufacture. Mylan has found that out the hard way and is having to expand a recall of cancer drugs that it began in April because they may contain particulate. Some of the drugs were manufactured for Pfizer.
The FDA has banned nearly two dozen plants operated by Indian drugmakers in the past two years, leading some in India's industry to complain that the FDA has it in for the country's drugmakers. It is a contention that the FDA denies. Now, a new survey by a private consulting firm shows that a lot of industry insiders in India recognize there are shortcomings in compliance at their companies.
Hospira recalled more than 60 lots of the pain reliever ketorolac tromethamine injection in January because of the potential for crystals in the 18 million vials that had been shipped in the U.S. and Singapore.
Indian drugmaker Wockhardt says remediation work at two plants that the FDA banned in 2013 will drag into 2016. The remarks by Chairman Habil Khorakiwala came a day after the drugmaker reported that sales in the U.S. last fiscal year were off by 50%.
The European Medicines Agency is standing by its original recommendation made earlier this year to suspend a number of medicines that received European Union clearance based on clinical studies conducted by GVK Biosciences in India.
Singapore, like other Asian countries looking to woo pharmaceutical manufacturers, is moving quickly to meet increasing demand for high-quality water required by strict regulations in the U.S. and European Union.
Cipla announced a drug recall of its asthma inhalant levalbuterol from the U.S. market following an FDA warning, and Wockhardt withdrew about a dozen drugs on manufacturing concerns at two of its plants in India.