The company expects to launch its patented brand formulation of the acne medication isotretinoin in the fourth quarter of 2012, in the US.
Cipher president and CEO Larry Andrews said, "We look forward to working closely with our partner, Ranbaxy Laboratories Inc., in preparation for the upcoming U.S. launch of the product through its dermatology sales force."
The approval triggers $9m milestone from Ranbaxy approximately $4.5m of which will be shared with Galephar.
According to the agreement, Cipher will also receive royalties on net US sales and is eligible for future milestone payments based on sales targets.