Gloversville drug maker working to satisfy FDA

Ranbaxy Laboratories officials said Thursday that they are working to come into compliance with fede

Ranbaxy Laboratories officials said Thursday that they are working to come into compliance with federal regulations to prevent a shutdown of their liquid pharmaceuticals manufacturing plant on West Fulton Street.

The Ohm Laboratories Inc. plant in Gloversville is one of three pharmaceuticals manufacturing plants in the U.S. owned by generic drug giant Ranbaxy. The facility received a warning letter from the U.S. Food and Drug Administration in December.

According to the letter, available on the FDA’s Web site, Ranbaxy’s Gloversville facility was in violation of federal manufacturing guidelines when it was inspected in August, including manufacturing a drug not approved for sale in the U.S.

Ranbaxy spokesman Charles M. Caprariello said his company disputes the FDA’s claim that Ohm was manufacturing an unapproved drug. He said the issue is a technical misunderstanding.

“All our products are FDA approved; there was a misunderstanding because we manufacture one product for another company,” he said. “We’re working with officials on that. There were observations that were made and we have to work with them to effectively resolve all of the issues they’ve identified in a timely fashion.”

Caprariello said his company plans to continue operations at the West Fulton Street plant, which makes all of Ranbaxy’s liquid drug products for the U.S. He said the facility employs between 16 and 18 people.

In a written statement, Ranbaxy Laboratories officials said Ohm has retained the services of global consulting firm PRTM Inc. to provide expertise and advice on issues cited by the FDA at the Gloversville plant.

In 2008, the FDA issued an “import alert” blocking Ranbaxy from shipping more than 30 drugs to the U.S. because of concerns about manufacturing practices at two manufacturing plants in India.

Caprariello said Ranbaxy still hasn’t resolved the FDA’s concerns about the plants in India. He said those plants are much larger than the Ohm plant in Gloversville and the FDA had many more concerns about them. He said Ohm’s two manufacturing plants in New Jersey, which have not been cited by the FDA, have picked up production to compensate for the import block on the facilities in India.

“We would anticipate that [a shutdown of the Gloversville plant won’t] happen, and we’re working diligently to get that done,” he said.

FDA officials Thursday said they couldn’t comment on the matter.

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