IGMPI India



Ranbaxys U.S. plant gets USFDA clearance

According to the US Food and Drug Administration (FDA), their findings about the manufacturing practices at Ranbaxy's US facility, Ohm Laboratories Inc, are found satisfactory. This clearance from FDA also allows Ranbaxy to file applications for approvals for generics or off patent drugs from Ohm. This can sound like some relief to the drug company after the controversies created regarding three of its manufacturing units in India.
The United States is an important market for Ranbaxy’s product circulation and has always contributed to a large share of sales to the company. The manufacturing unit located at Ohm, is now the most important manufacturing plant of Ranbaxy that supplies products to the US market.

The other three facilities that supplied drugs to the US market are in India and have been under USFDA scanner for non-compliance of GMP standards. The manufacturing units at Paona Sahib in Himachal Pradesh, Dewas in Madhya Pradesh have been banned and now the plant in Mohali in Punjab has received an import alert. After payment of fine, the company has signed a consent decree and agreed to remain compliant with GMP standards. The company aims at working to resolve the issues at Mohali manufacturing plant and take measures to maintain GMP compliance.