As its multinational drugmaker partner ends supply deal with Claris Lifesciences, city-based generic injectables player has decided to go alone in the US market.
The company will no longer supply to the US through any of its partners, but would sell on its own.
The company said in a release to the Bombay Stock Exchange (BSE) that it no longer wishes to pursue its strategy to supply to the US through any of its partners including Pfizer, West-Ward Pharmaceuticals Inc and Sagent. Claris will sell on its own through its subsidiary Claris Lifesciences Inc.
"The company is confident of selling on its own in the US and this strategy could be beneficial for the growth of the company as the pricing of products under the direct sale would be better than the supply through partners", Claris said.
Claris had entered into a supply deal with Pfizer in 2009 to gain access to markets like the US, Europe and Australia. Pfizer was selling 15 off-patent parenteral drugs that were manufactured by Claris. Pfizer had commercialised these off-patent drugs in the Western markets under its own brand name.
However, during April-May 2010, Claris' US distributor Sagent Pharmaceuticals and its customer Pfizer had reported that the Metronidazole injection USP IV bags were contaminated with fungi. After the alert, Claris itself had announced a nationwide recall of all lots of Ciprofloxacin, Metronidazole and Ondansetron from the country voluntarily.
More From This Section
"Post the recall, Pfizer and Claris had reviewed the supply agreement in the wake of the import alert and the warning letter and the supply agreement with Pfizer is terminated. The company had been selling in the US;before it had partnered with other companies;through its wholly owned subsidiary, Claris Lifesciences Inc, and had developed adequate capabilities to sell on its own.", Claris said in a statement here.
Following the recall, the USFDA too had issued a notice in November 2010 barring the company from exporting products manufactured at its Bavla site near Ahmedabad.
One and half years after receiving the FDA warning letter, Claris has finally managed to resolve the quality issue with the US drug regulator. The company received a formal letter from the regulator saying that it has completed evaluations of the firm's corrective actions taken at the Bavla plant earlier this week, thus paving way for Claris to re-start exports to the US.
However, Pfizer lost business during the period and the termination of the contract is a likely fall-out of that.