Jubilant Life Sciences has turned a corner at its HollisterStier sterile manufacturing facility in Washington state, highlighting an Indian success story of sorts on the long road of U.S. FDA manufacturing inspections.
The plant has been upgraded following inspections by the U.S. FDA last year that stemmed from a late 2013 violation notice.
At the time, the FDA said the plant had several good manufacturing violations, including a failure to assure adequate cleaning and disinfecting processing areas and equipment.
Among the specific notices by the FDA in 2013, posted on the FDA website, the plant lacked appropriate written procedures to prevent microbiological contamination of sterile drugs or products purporting to be sterile.
|Jubilant chairman Shyam Bhartia|
However, Jubilant appears to have been aggressive in fixing the Washington plant and at raising money and hiring experts to take a look at its global operations.
In May last year, a member of the World Bank loaned Jubilant Pharma $147.5 million aimed in part to improve its generic drug manufacturing plants in India while also tapping the bank's emerging market healthcare expertise.
Around the same time, an FDA-licensed plant in Canada passed inspection and the company also turned a corner on its manufacturing commitments to the FDA.
"Jubilant remains committed to continuous improvements to maintain compliance at all its pharmaceutical manufacturing facilities across the globe," Shyam Bhartia, chairman, and Hari Bhartia, co-chairman and managing director of Jubilant, said in a release on the Washington plant.
"We consider this development as another step towards building a reliable and sustainable pharmaceutical business."
- here's the Jubilant release