The development comes in the wake of the strategic alliance between Ipca Laboratories Ltd and US-based Ranbaxy Pharmaceuticals Inc, a wholly owned subsidiary of RLL. Under the strategic alliance, this was the fourth such product for which approval had been received from USFDA, a company release here today said.
Initially, Ohm would manufacture the formulation and Ranbaxy would market it in the US healthcare system, using Ipca's DMF approved active pharmaceutical ingredient (API)-Hydrochlorothiazide.
Later, Ipca would manufacture this formulation, using its facilities in India.
Ipca was setting up a new formulations manufacturing facility, meeting US regulatory requirements at Indore SEZ.
Ranbaxy would commercialise this product in the US market using its established marketing expertise and distribution network, the release added.