Sun Pharma Still Has FDA Problems

Sun Pharma Still Has FDA Problems

September 12th, 2012 // 5:20 pm @ jmpickett

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Late last month, Sun Pharma happily declared that its Caraco unit was finally in compliance with good manufacturing practices after receiving notice from the FDA. This meant that two manufacturing and packaging facilities in Michigan were able to resume limited operations after various inspections and so-called 483 reports had been issued by the agency. Specifically, Caraco can now resume production of just two products – Carvedilol USP and Paramomycin USP

“Manufacturing of other products from these sites, including those pending approval with the USFDA, will be subject to similar rigorous approval procedure. As a result, the increase in production at these sites and resultant revenue contribution is expected to be gradual,” the Indian drugmaker, whose unit had been operating under a 2009 consent decree, said in a statement. Regular inspections will, otherwise, continue for an extended period.

Just one week later, though, Caraco had to recall a lot of Nimodipine capsules that are used to reduce bleeding in the brain. The voluntary measure was made because crystals formed in the gel capsules, which effected bioavailability. “Although clinical health implications are unknown, use of the product when the nimodipine has crystallized in the capsule may be of great clinical significance,” the recall notice says (read here).

The voluntary recall is unrelated, actually, to the production issues in Michigan, because the Nimodipine capsules are made by Pharmaceutics International, a contract manufacturer. A Pharmaceutics official, who confirmed the relationship, but asked not to be named, explained that the crystallization occurred due to dosage formulation, but was not related to a manufacturing issue. “There were no batch record deviations or GMP issues,” the official said.

Just the same, the timing is inopportune for Sun, which is one of the largest generic drugmakers in India and, like so many foreign drugmakers, is under increasing scrutiny from the FDA as the agency grapples with increased pressure to monitor the global supply chain. As the agency will remind drugmakers, they are, ultimately, responsible for product churned out by contract manufacturers, regardless of the underlying problem. The recall may likely serve, therefore, as one more reminder for FDA inspectors to keep a close watch.