Ranbaxy's active pharmaceutical ingredient (API) manufacturing factory in Toansa, Punjab has received a Form 483 warning from the US FDA, communicating concerns discovered during last week's inspection.
As Ranbaxy's main API factory, the Toansa facility supplies about 70% of the raw ingredients for production, including supplying to Ranbaxy's Ohm Laboratories plant in New Jersey.
Other India-based Ranbaxy factories — at Paonta Sahib (Himachal Pradesh), Dewas (Madhya Pradesh) and Mohali (Punjab) — are already barred from exporting drugs to the US.
In a press statement, Ranbaxy said it will assess the observations and respond to the FDA.
Read the Business Standard press release