Dr Reddy’s says two plants clear FDA inspections

pharmafile | October 28, 2011 | News story | Manufacturing and Production Dr Reddy's, FDA 483s, India, generics 

Two manufacturing facilities operated by Indian drugmaker Dr Reddy’s Laboratories successfully passed inspections by the FDA, although a plant in Mexico remains under scrutiny.

Chief executive G. V. Prasad provided these updates during the firm’s second-quarter earnings call earlier this week, and noted that Dr Reddy’s plants in Bollaram, India, and Shreveport in the USA passed inspections with no negative ‘483’ observations from the FDA.

The endorsement of Dr Reddy’s active pharmaceutical ingredient (API) manufacturing unit at Bollaram in Hyderabad is good news, as the plant hit the headlines recently after two incidents involving worker fatalities. Two workers died in a fire there earlier this year, while there were two other deaths at the end of 2010 as a result of a gas leak.  

Meanwhile, Dr Reddy’s Shreveport facility is currently being expanded with a $16.5 million investment programme that should increase worker numbers at the plant by around 100 to 260-plus in mid-2012. The 300,000 sq. ft. facility is the largest producer of silver sulfadiazine cream and the second-largest producer of Ibuprofen for the North American market, and the latest phase of expansion is intended to allow multiple new products to be made at the site.

Regarding the Mexican API facility at Jiutepec, Prasad noted that Dr Reddy’s submitted responses to the FDA regarding recent quality failures, adding that remedial measures “are pretty much on track and progressing as per our expectations”.

The company expects a re-inspection of the plant by the FDA in the “near future”. Jiutepec has the world’s largest capacity for sodium naproxen as well as specialist steroidal API-producing capabilities. 

Meanwhile, Dr Reddy’s has great expectations for its recently-introduced fondaparinux product- a generic version of GlaxoSmithKline’s Arixtra – which was approved in the USA in July – and is progressively ramping up manufacturing capacity for the product after a slightly slow start.  

The drugmaker now estimates it has around 10% market share for the drug, which is licensed from Australian company Alchemia, and is part of a new portfolio of medicines designed to be less vulnerable to competition because they are relatively complex and challenging to make.

Overall, the company reported consolidated revenues of $462 million, up 21% year-on-year, with generic drugs contributing $329 million, up 18%, and pharmaceutical services and API sales bringing in $121 million, a rise of 28%.

Phil Taylor

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