FDA inspectors found a lot they didn't like about an API manufacturing plant in Japan, including dirty equipment, little ingredient testing and inconsistent practices for identifying lots. The problems at the plant provide an indication of why some Japanese companies have been looking to India as a growing source of APIs.
FDA inspectors went through the Asada Milling Co. plant in Gunma last October. According to the warning letter posted to the FDA site today, the API maker was not testing raw ingredients coming in the door to make sure they met specifications or finished APIs going out the door to see if the were safe and effective.
The company also appeared to have no written procedures for assigning lot numbers and so was not giving lots unique identifiers. "While firm officials stated that certain unwritten rules are followed in creating batch numbers, application of these rules appeared to be inconsistent," the letter says. The report also noted corroded and rust-covered equipment. It said walls, floors and equipment in the mixing room were covered with a white powder.
There has been a burst of activity in recent months as Japanese companies tie up with Indian API manufacturers. The move comes even as Japan is moving to more generic drugs to lower healthcare costs for an aging population. In January, Mitsui said it paid about ¥5.9 billion ($68 million) to boost its investment in Arch Pharmalabs to about 32%. The Japanese investment group noted that Arch has several plants serving both generic and branded drug clients. Last month, Mitsubishi said it was investing in Hyderabad-based Neuland Laboratories, which would expand its API production there and dedicate it to Mitsubishi.
The Pharmaceuticals Export Promotion Council of India (Pharmexcil) says that API sales to Japan have been growing rapidly, according to the Business Standard. Ahmedabad-based Dishman Pharmaceuticals told the newspaper that it expects its API sales in Japan grow to about $10 million this year, up from about $1.5 million last year.