2008-09 was a challenging year. In manyways. Every single economy of the world witnessed an economic downturn fuelled by the global liquidity crisis. The speed and the impact were in itself, daunting. Within the changes and corrections in the global systems is a ray of hope, not just for the world but for pharmaceutical companies like ours, as the focus on affordable health care intensifies.
Coincidentally, we too went through one of our more challenging years since we started business. Though new situations have been part of our business ever since we started to build it in 1983 and grew it to a Rs. 42,723 million business by 2008-09, the circumstances that we faced in 2008-09 were very different in magnitude and character.
Our 76% USA subsidiary Caraco received a Form 483 on inspection conducted by US FDA at its Detroit manufacturing facilities. This was followed by a warning letter on quality and non-conformance with SOP for the same facility. This did not have a material impact on the products that were already sold from this facility but it does block the approval of 25 pending ANDAs from Caraco. Caraco has since responded to the same. Caraco also had to recall all tablets of its brand Digoxin distributed prior to March 2009 as they differed in size. As communicated earlier, with support from Sun, Caraco is working hard to address these issues and ensure that such instances do not recur. From March beginning until May, the FDA conducted an inspection as a follow-up to its October 2008 warning letter and Caraco's subsequent response. On completion, the FDA investigators provided Caraco with a list of their observations on FDA Form 483, which Caraco has committed to provide a written response to. However, there were no deficiencies identified during the FDA inspection in the Quality Control Laboratory.
US FDA denied approval for our ANDA for generic Effexor XR®. The US FDA responding to a Citizen's Petition from Osmotica, also asked Sun Pharma to resubmit the ANDA if we wanted an approval. We have not been sued for our subsequent filing, but the generic approval will take its own course.
The Taro acquisition is under process. Mediation that was initiated on the recommendation of the Supreme Court of Israel, ended without any agreement being reached. A judgement is now awaited from the honourable court.
While these challenges called for quick responses, they did not affect the functioning of our underlying business across geographies. Our businesses continued to grow, add strength and earn a reasonable return. These events have made us stronger, and hopefully we are now better prepared to deal with similar, or even larger, situations in the future.
To quickly recap our 2008-09 results: We recorded sales of Rs. 42,723 million, a growth of 27% over the previous year Between Sun Pharma and Caraco, 38 ANDAs were filed covering 37 products 42 products were launched in India and ANDAs for 18 products were approved for the US We received the first approval for a controlled substance ANDA from our Cranbury, New Jersey facility Our expansion plans at Dadra, Halol and Detroit are being completed as per schedule.
Challenges and Beyond
