Two weeks ago, India's Anuh Pharma let authorities in India know that its Boisar plant had been banned from shipping products to Europe after the European Medicines Agency (EMA) put the kibosh on its manufacturing certificate. The drugmaker said it was all about getting things fixed but didn't say what was in store to make that happen. According to an EMA report, quite a lot.
In its report following a February visit, the EMA said French inspectors documented two dozen deficiencies at the plant and found overall quality so lacking that it recommended recalling from Europe all of the antibiotic APIs the plant manufactures because their original sources were unknown. It named 8, including chloramphenicol, roxithromycin and azithromycin, but said the list may not be exhaustive. In the case of azithromycin, it said the source was known and that it came from Hebei Dongfeng Pharmaceutical in China, a producer that the EU had banned in 2014 for a long list of GMP deviations.
"The findings reveal a critical non-compliance of the quality system of the company as a whole," the report reads. "Moreover, due to the severe lack of transparency of the company regarding its manufacturing activities, there is no assurance as regards to the origin of every batch of active substances claimed to have been manufactured by the company at the Boisar site. Consequently, it is considered that the identified risks are applicable to all active substances manufactured at the site."
Anuh is the latest Indian drugmaker that Western authorities have nailed for poor manufacturing or data integrity issues. Just this week, both Natco Pharma and Lupin Pharmaceuticals reported getting Form 483s after inspections of plants by the FDA. Last year the FDA, EMA and Canada all suspended sales of products coming out of Polydrug Laboratories at its plant in Maharashtra after inspectors found problems with cross-contamination and that the company was ignoring customer complaints.
- here are the BSE filings