Orchev Pharma Pvt. Ltd. is involved in the process of manufacturing quality Active Pharma Ingredients and Intermediates in accordance with GMP, USFDA and ICH Q7 guidelines. Our plant located at Rajkot has the following regulatory approvals for Ranitidine:
USFDA [AUGUST-2018]
EU- GMP (AEMPS- SPAIN) [JUNE-2015]
EDQM – COS
WHO – GMP (local)
Chinese DMF # Y20220000306 registration successful with IDL Status “A”
Korean Food and Drug Administration (KFDA)
COFEPRIS – Mexican Health Authority [May 2013]
DMF filed with TPD – Canada
Ranitidine HCl registered with RUSSIAN – State registration of medicinal products
ISO 9001:2015 issued by TUV SUD
Registration in Ukraine
Registration in Uzbekistan
Registration with IRAN MOH