Dr Reddy’s API plant in Mexico under FDA scrutiny
pharmafile | June 21, 2011 | News story | Manufacturing and Production | APIs, Dr Reddy's, FDA, GMP violations, pharma manufacturing news
Indian drugmaker Dr Reddy’s Laboratories has been sent a warning letter by the US FDA after a manufacturing facility in Mexico failed an inspection.
The plant in Jiutepec, Morelos is operated by subsidiary company Industrias Quimicas Falcon de Mexico and manufactures intermediates and active pharmaceutical ingredients (APIs) for use in Dr Reddy’s generic medicines.
An inspection by the US regulator in November 2010 revealed a number of Good Manufacturing Practice violations in the production of APIs, focusing particularly on analytical methods, according to the FDA’s warning letter.
Dr Reddy’s filed a response to the violations cited by the inspectors in December 2010 but failed to reassure the FDA that the remedial measures it proposed went far enough.
The agency’s primary concern was that methods used to test APIs, including high-performance liquid chromatography (HPLC) analyses, had not been validated and raised the risk that ‘adulterated’ API could reach the US market.
The letter also notes that several areas of the plant had no cleaning validation for manufacturing equipment, and the site quality unit had failed to properly investigate out-of-specification (OOS) testing results. In some cases there were four to eight-month delays in reporting failed stability tests for batches.
“Your firm’s quality unit did not exercise its responsibility to ensure the APIs manufactured were in compliance with GMP, and met intended specifications for quality and purity,” notes the letter, which includes the usual warning that the FDA may block approval of products using APIs made at the plant if the violations are not addressed.
“Dr Reddy’s takes these matters seriously and will respond to the US FDA within the stipulated timeframe,” said the firm in a statement.
Dr Reddy’s acquired the Jiutepec site from Roche in 2005. It is one of eight API-producing facilities operated by the firm – six others are based in India with one in the UK – and has the world’s largest capacity for sodium naproxen as well as specialist steroidal API capacities.
Phil Taylor
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