Zydus Cadila, which had its U.S. business interrupted in 2014 after running afoul of FDA manufacturing standards, said in a brief statement on Friday that it is returning to the U.S. market.
The Indian drugmaker said in a filing with the Bombay Stock Exchange that it has received FDA approval to ship doxycycline capsules. "With this first approval, the group will now commence supplies to the U.S. market from its formulation manufacturing facility located at the SEZ in Ahmedabad," it reported.
It is the second piece of good news for the Indian drugmaker as it works to repair its U.S. business. Last month it reported it had received an FDA Establishment Inspection Report (EIR) for a plant in Himachal Pradesh. The agency issues an EIR when it has wrapped up its inspection of a facility. The company reported it that it will now seek approvals for other products from the plant in Himachal Pradesh.
The drugmaker has been under pressure since receiving Form 483s in 2014 for a key formulation plant in Moraiya near Ahmedabad, as well as its Zyfine API plant in Ahmedabad.
The extent of those issues became clear last month when the FDA posted the warning letter, which expressed the agency's serious concerns about Cadila's production of warfarin products in 2014, stating: "These persistent failures indicate that your manufacturing process is not in a state of control."
The drugmaker has said it is working closely with the FDA to get its operations back on track at the two plants and is committed to a revamp of its quality systems. Its targeted facilities are on a long list of Indian plants currently under some kind of action by the FDA, including facilities owned by Sun Pharmaceutical, Dr. Reddy's Laboratories ($RDY) and Mylan ($MYL).
- here's the BSE filing (PDF)