Regulatory Approvals

Orchev Pharma Pvt. Ltd. is involved in the process of manufacturing quality Ranitidine Hydrochloride in accordance with GMP, USFDA and ICH Q7 guidelines. Our plant located at Rajkot is manufacturing only one API, i.e., Ranitidine Hydrochloride. The plant received renewal from local GMP in September 2009. In March 2010, the plant received COS from EDQM having approval number CEP 2007 – 320. The plant has been audited by Korean Food and Drug Administration and we are on the verge of receiving their approval. Orchev Pharma not only believes in providing best quality of Ranitidine HCl, but also supports costumers with Drug Master File for dossier form application.