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FDA Approval granted to Zydus Cadilla for Ahemdabad Plant


FDA Approval granted to Zydus Cadilla for Ahemdabad Plant

Zydus Cadilla has  announced its return to the US business market . Cadilla’s U.S. business was closed down  in 2014, when the company was caught for malpractice of flouting FDA manufacturing standards.

According to Fierce Pharma Manufacturing the Indian owner of Zydus Cadilla has announced the FDA permission given to the company to ship Doxycycline capsule in a Bombay Stock Exchange filing . The approval will see the company begin sending supplies of the medicine from its manufacturing facility in Ahmedabad.

The first good news that the industrialist business man received was  an FDA Establishment Inspection Report (EIR) for a plant in Himachal Pradesh last month, signaling the wrap up of the inspection of the unit by the FDA .

The company now plans to expand business by increasing its range of products from this unit  at Himachal Pradesh.

After Cadilla received form 483s in the year 2014,  for its key manufacturing unit in Moraiya near Ahemdabad and Zyfine API plant in the state, the industrialist has been under tremendous pressure. The seriousness of the two issues became apparent in FDA’s letter expressing anxious concerns about the Warfarin products in 2014. “These persistent failures indicate that your manufacturing process is not in a state of control.” The letter made clear to him.

Keen to get its unit  back on operational track, the drug maker industrialist is working in close collaboration with the FDA. He has reiterated his commitment to bringing about the necessary changes to ensure quality product.

Zydus Cadilla is one of the long list of Indian company’s on the FDA’s list for playing foul.



Source: with inputs from fierce pharma
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